AzTrials
AzTrials

Recurrent Lung Non-Small Cell CarcinomaPhase 2/3NCT06616584

Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemotherapy and Immunotherapy (An Expanded Lung-MAP Treatment Trial)

A Phase 2/3 study testing Biospecimen Collection, Cemiplimab and Computed Tomography in people with Recurrent Lung Non-Small Cell Carcinoma and Stage IV Lung Cancer AJCC v8, run by SWOG Cancer Research Network at 413 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase II/III Expanded Lung-MAP treatment trial compares the effect of adding cemiplimab to docetaxel and ramucirumab versus docetaxel and ramucirumab alone in treating patients with non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Cemiplimab and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
378 participants
Where
413 sitesUnited States
Study dates
22 May 2025to 31 Dec 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have been assigned to S1800E by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1800E is determined by the LUNGMAP protocol
  • Participants must have measurable or non-measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to randomization. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to randomization. All disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration
  • Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to randomization
  • Participants must have received exactly one anti-PD-1 or anti-PD-L1 therapy for advanced disease (stage IV or recurrent disease, or stage I-III disease in certain circumstances outlined below). Anti-PD-1 or anti-PD-L1 therapy may have been given alone or in combination with other therapy. For participants who received neoadjuvant, adjuvant, and/or consolidation anti-PD-1 or anti-PD-L1 therapy for stage I-III disease:
  • If they experienced disease progression within (≤) 365 days from initiation (cycle 1 day 1) or anti-PD-1 or anti-PD-L1 therapy, this counts as the single allowed anti-PD-1 or anti-PD-L1 therapy for advanced disease
  • If they experienced disease progression more than (>) 365 days from initiation (cycle 1 day 1) or anti-PD-1 or anti-PD-L1 therapy, this is not considered anti-PD-1 or anti-PD-L1 therapy for advance disease. These participants must have received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease
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  • Participants must have experienced disease progression (in the opinion of the treating investigator) more than (>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or anti-PD-L1 therapy
  • Participants who received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease must have had a best response of stable disease, partial response or complete response (in the opinion of the treating investigator) on the anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease
  • Participants must have received platinum-based chemotherapy and experienced disease progression (in the opinion of the treating investigator) during or after this regimen
  • Participants with a known sensitizing molecular alteration for which a Food and Drug Administration (FDA)-approved targeted therapy for NSCLC exists (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, KRAS, HER2, and MET sensitizing mutations), must have previously received at least one of the approved therapy(s). Prior targeted therapy for participants with targetable alterations is allowed if all other eligibility criteria are also met
  • Participants must have recovered (≤ grade 1) from any side effects from the most recent anti-cancer treatment prior to randomization
  • Participants must not have received prior therapy with docetaxel for this disease
  • Participants must not have received any palliative radiation therapy within 14 days (or palliative bone radiation therapy within 7 days) prior to randomization
  • Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, or biologic therapy for cancer treatment while receiving treatment on this study
  • Participants must not have undergone major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization. Participants must not have postoperative bleeding complications or wound complications from a surgical procedure performed within 2 months prior to randomization. The participant must not have elective or planned major surgery to be performed during the course of this study
  • Absolute neutrophil count ≥ 1.5 x 10^3/uL (within 28 days prior to randomization)
  • Hemoglobin ≥ 9.0 g/dL (within 28 days prior to randomization)
  • Platelets ≥ 100 x 10^3/uL (within 28 days prior to randomization)
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to randomization) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN (within 28 days prior to randomization). Participants with history of liver metastasis must have AST and ALT ≤ 5 x ULN
  • Participants must have a creatinine ≤ the institutional (I)ULN or calculated creatinine clearance ≥ 50 mL/min using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to randomization
  • Participants must have a urinary protein test performed within 28 days prior to randomization
  • Participants' most recent Zubrod/Eastern Cooperative Oncology Group (ECOG) performance status must be 0-1 and be documented within 28 days prior to randomization
  • Participants must have a completed medical history and physical exam within 28 days prior to randomization
  • Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated by the treating investigator
  • Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization, if indicated by the treating investigator
  • Participants with known human immunodeficiency virus (HIV) infection are eligible, provided they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to randomization
  • Participants must not have a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
  • Participants must not have an active autoimmune disease that has required systemic treatment within 730 days prior to randomization (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
  • Participants must not have any history of primary immunodeficiency
  • Participants must be able to safely receive study therapy and must not have experienced the following:
  • Any grade 3 or worse immune-mediated adverse event. Exception: asymptomatic nonbullous/nonexfoliative rash
  • Any unresolved grade 2 immune-mediated adverse event
  • Any toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy
  • Exception to the above: Toxicities of any grade that requires replacement therapy and has stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are allowed
  • Participants must not have any history of organ transplant that requires use of immunosuppressives
  • Participants must not have received a live or live attenuated vaccine within 28 days prior to randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever rabies, Bacillus Calmette-Guerin (BCG) and typhoid vaccine. Seasonal influenza vaccines and COVID-19 vaccines are allowed, however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated and are not allowed
  • Participants must not have clinical signs or symptoms of active tuberculosis infection
  • Participants must not have a history of (non-infectious) pneumonitis that required steroids or current pneumonitis/interstitial lung disease
  • Participants must not have had a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization
  • Participants must not have a history of gastrointestinal perforation or fistula within 6 months prior to randomization
  • Participants must not have grade 3-4 gastrointestinal bleeding (defined by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]5) within 3 months prior to randomization. No history of gastrointestinal (GI) bleed within 3 months prior to randomization
  • Participants must not have any grade III/IV cardiac disease as defined by the New York Heart Association criteria (i.e., participants with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months prior to randomization, or serious uncontrolled cardiac arrhythmia
  • Participants must not have experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to randomization
  • Participants must not have gross hemoptysis within two months prior to randomization (defined as bright red blood or ≥ 1/2 teaspoon) or with radiographic evidence of intratumor cavitation or has radiologically documented evidence of major blood vessel invasion or encasement by cancer
  • Participants must not have been diagnosed with venous thrombosis within 3 months prior to randomization. Participants with venous thrombosis diagnosed more than 3 months prior to randomization must be on stable doses of anticoagulants
  • Participants must not have cirrhosis at a level of Child-Pugh B (or worse) AND a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis, OR any degree of cirrhosis
  • Participants must not be pregnant or breastfeeding (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
  • Participants must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)
  • Participants must be offered participation in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG specimen tracking system
  • NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. NOTE: Participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations

Who cannot join

None listed.

Trial locations and contacts

413 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jennifer Beeler contact

210-614-8808

jbeeler@swog.org

SWOG Network Operations Center contact

protocols@swog.org

300 sites in 1 country

United States300 sites, 289 recruiting

  • UM Upper Chesapeake Hematology and Oncology - Aberdeen

    Aberdeen, Maryland, 21001

    Site Public Contact, 443-643-1029, nfadrwoski@umm.edu

    Ashkan Bahrani

    Recruiting

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

    Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu

    Moises Harari-Turquie

    Recruiting

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

    Site Public Contact, 806-212-1985, Gina.Cravey@bsahs.org

    Anita Ravipati

    Recruiting

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Eric C. McGary

    Recruiting

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

    Suspended

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

    Site Public Contact, 864-512-4651, rhonda.ballew@anmedhealth.org

    Jay B. Nayak

    Recruiting

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • OhioHealth O'Bleness Hospital

    Athens, Ohio, 45701

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Zachary Trisel

    Recruiting

  • Grady Health System

    Atlanta, Georgia, 30303

    Site Public Contact, 404-778-1868

    Jennifer W. Carlisle

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Site Public Contact, 888-946-7447

    Jennifer W. Carlisle

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Site Public Contact, 404-778-1868

    Jennifer W. Carlisle

    Recruiting

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

    Site Public Contact, 404-851-7115

    Jennifer W. Carlisle

    Recruiting

  • Northside Hospital

    Atlanta, Georgia, 30342

    Site Public Contact, 404-303-3355, ClinicalTrials@northside.com

    I-wen Chang

    Recruiting

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

    Site Public Contact, 207-626-4855

    Xiao Hu

    Recruiting

  • Advocate Outpatient Center - Aurora

    Aurora, Illinois, 60506

    Site Public Contact, ncorp@aah.org

    Thomas J. Saphner

    Recruiting

  • Saint Alphonsus Cancer Care Center-Baker City

    Baker City, Oregon, 97814

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    Christopher M. Reynolds

    Recruiting

  • Kaiser Permanente-Baldwin Park

    Baldwin Park, California, 91706

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Eric C. McGary

    Recruiting

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

    Site Public Contact, 410-368-2910

    Carole B. Miller

    Recruiting

  • Kaiser Permanente-Woodlawn Medical Center

    Baltimore, Maryland, 21244

    Site Public Contact, 240-632-4285, Charmaine.A.Mckie@kp.org

    James Liu

    Recruiting

  • Advocate Good Shepherd Hospital

    Barrington, Illinois, 60010

    Site Public Contact, 847-842-4847

    Thomas J. Saphner

    Recruiting

  • UPMC-Heritage Valley Health System Beaver

    Beaver, Pennsylvania, 15009

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Liza C. Villaruz

    Recruiting

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

    Site Public Contact, 443-643-3010

    Ashkan Bahrani

    Recruiting

  • MaineHealth Waldo Hospital

    Belfast, Maine, 04915

    Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org

    Xiao Hu

    Recruiting

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Eric C. McGary

    Recruiting

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

    Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • University of Iowa Healthcare Cancer Services Quad Cities

    Bettendorf, Iowa, 52722

    Site Public Contact, 563-355-7733, katherine-daprile@uiowa.edu

    William A. Zeitler

    Recruiting

  • Beverly Hospital

    Beverly, Massachusetts, 01915

    Site Public Contact, 978-922-3000 ext. 2405

    Karl J. D'Silva

    Recruiting

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211

    Site Public Contact, towercancerresearch@toweroncology.com

    Karen L. Reckamp

    Recruiting

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

    Site Public Contact, 800-996-2663, research@billingsclinic.org

    John M. Schallenkamp

    Recruiting

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Saint Joseph's/Candler - Bluffton Campus

    Bluffton, South Carolina, 29910

    Site Public Contact, 912-819-5704, underberga@sjchs.org

    Mark A. Taylor

    Recruiting

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Charles W. Drescher

    Recruiting

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Lafayette Family Cancer Center-EMMC

    Brewer, Maine, 04412

    Site Public Contact, 800-987-3005

    Sarah J. Sinclair

    Recruiting

  • United Hospital Center

    Bridgeport, West Virginia, 26330

    Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu

    Mohammed Almubarak

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • MaineHealth Cancer Care and IV Therapy - Brunswick

    Brunswick, Maine, 04011

    Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org

    Xiao Hu

    Recruiting

  • Lahey Clinic

    Burlington, Massachusetts, 01805

    Site Public Contact, 781-744-3421, lhmc-cancer-clinical-trials@lahey.org

    Karl J. D'Silva

    Recruiting

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • UPMC Hillman Cancer Center at Butler Health System

    Butler, Pennsylvania, 16001

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Liza C. Villaruz

    Recruiting

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Marshall Cancer Center

    Cameron Park, California, 95682

    Site Public Contact, 530-672-7050, cancerservices@marshallmedical.org

    Tianhong Li

    Recruiting

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Aultman Health Foundation

    Canton, Ohio, 44710

    Site Public Contact, 330-363-7274, ClinicalReserachDept@aultman.com

    Raza A. Khan

    Recruiting

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

    Site Public Contact, 573-334-2230, sfmc@sfmc.net

    Bryan A. Faller

    Recruiting

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Physicians' Clinic of Iowa PC

    Cedar Rapids, Iowa, 52402

    Site Public Contact, 319-297-2900

    Bharat Jenigiri

    Recruiting

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • WellSpan Medical Oncology and Hematology

    Chambersburg, Pennsylvania, 17201

    Site Public Contact, 717-217-6020

    Ikechukwu I. Akunyili

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu

    Christopher A. Rangel

    Recruiting

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

    Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu

    Richard D. Hall

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Site Public Contact, 312-695-1301, cancer@northwestern.edu

    Young Kwang Chae

    Recruiting

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

    Site Public Contact, 773-296-5360

    Thomas J. Saphner

    Recruiting

  • Enloe Medical Center

    Chico, California, 95926

    Site Public Contact, 530-332-4700

    Tianhong Li

    Recruiting

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Saiama N. Waqar

    Recruiting

  • Louis Stokes Cleveland VA Medical Center

    Cleveland, Ohio, 44106

    Site Public Contact, holly.henry@va.gov

    Charles J. Nock

    Recruiting

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Baptist Memorial Hospital and Cancer Center-Collierville

    Collierville, Tennessee, 38017

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Wail Alnas

    Recruiting

  • Baptist Memorial Hospital and Cancer Center-Golden Triangle

    Columbus, Mississippi, 39705

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Wail Alnas

    Recruiting

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Zachary Trisel

    Recruiting

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Zachary Trisel

    Recruiting

  • Grant Medical Center

    Columbus, Ohio, 43215

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Zachary Trisel

    Recruiting

  • Doctors Hospital

    Columbus, Ohio, 43228

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Zachary Trisel

    Recruiting

  • New Hampshire Oncology Hematology PA-Concord

    Concord, New Hampshire, 03301

    Site Public Contact, 603-224-2556

    Michael S. Buff

    Recruiting

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • UPMC Hillman Cancer Center - Passavant - Cranberry

    Cranberry Township, Pennsylvania, 16066

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Liza C. Villaruz

    Recruiting

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Saiama N. Waqar

    Recruiting

  • Northwest Cancer Center - Crown Point

    Crown Point, Indiana, 46307

    Site Public Contact, 219-836-6879, CancerResearch@powershealth.org

    Tanmay Sahai

    Recruiting

  • AMG Crystal Lake - Oncology

    Crystal Lake, Illinois, 60014

    Site Public Contact, 630-929-6129, advocateresearch@advocate.com

    Thomas J. Saphner

    Recruiting

  • Aurora Saint Luke's South Shore

    Cudahy, Wisconsin, 53110

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • UPMC Western Maryland

    Cumberland, Maryland, 21502

    Site Public Contact, 240-964-1400

    Liza C. Villaruz

    Recruiting

  • MaineHealth LincolnHealth Hospital

    Damariscotta, Maine, 04543

    Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org

    Xiao Hu

    Recruiting

  • Carle at The Riverfront

    Danville, Illinois, 61832

    Site Public Contact, 800-446-5532, Research@Carle.com

    Tanmay Sahai

    Recruiting

  • Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis

    Daphne, Alabama, 36526

    Site Public Contact, 251-435-2273, donna.goggins@infirmaryhealth.org

    Jan O. Kemnade

    Recruiting

  • Miami Valley Hospital

    Dayton, Ohio, 45409

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Premier Blood and Cancer Center

    Dayton, Ohio, 45409

    Site Public Contact, 937-276-8320

    Tarek M. Sabagh

    Recruiting

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

    Site Public Contact, 404-321-6111 ext. 7632

    Badi El Osta

    Recruiting

  • Emory Decatur Hospital

    Decatur, Georgia, 30033

    Site Public Contact, 440-778-1868, clinicaltrialsoncology@dekalbmedical.org

    Jennifer W. Carlisle

    Recruiting

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Young Kwang Chae

    Recruiting

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Zachary Trisel

    Recruiting

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Zachary Trisel

    Recruiting

  • Smilow Cancer Hospital-Derby Care Center

    Derby, Connecticut, 06418

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Michael J. Grant

    Recruiting

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

    Site Public Contact, 815-285-7800

    Bryan A. Faller

    Recruiting

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515

    Site Public Contact, 630-275-1270, Barbara.barhamand@advocatehealth.com

    Thomas J. Saphner

    Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

    Site Public Contact, 800-826-4673, becomingapatient@coh.org

    Tanyanika L. Phillips

    Recruiting

  • Columbus Oncology and Hematology Associates

    Dublin, Ohio, 43016

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Zachary Trisel

    Recruiting

  • Dublin Methodist Hospital

    Dublin, Ohio, 43016

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Zachary Trisel

    Recruiting

  • Northside Hospital - Duluth

    Duluth, Georgia, 30096

    Site Public Contact, 404-303-3355, Clinical.trials@northside.com

    I-wen Chang

    Recruiting

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Durham VA Medical Center

    Durham, North Carolina, 27705

    Site Public Contact, 919-286-0411, VHADURcancertrials@va.gov

    Michael J. Kelley

    Recruiting

  • Northwest Oncology LLC

    Dyer, Indiana, 46311

    Site Public Contact, 219-924-8178

    Tanmay Sahai

    Recruiting

  • The Cancer Institute at Saint Francis Hospital

    East Hills, New York, 11548

    Site Public Contact, 516-325-7514, Stephanie.Solito@chsli.org

    Bhoomi Mehrotra

    Recruiting

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

    Site Public Contact, 800-446-5532, Research@carle.com

    Tanmay Sahai

    Recruiting

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Advocate Sherman Hospital

    Elgin, Illinois, 60123

    Site Public Contact, 847-429-2907

    Thomas J. Saphner

    Recruiting

  • Ephrata Cancer Center

    Ephrata, Pennsylvania, 17522

    Site Public Contact, 717-721-4840

    Ikechukwu I. Akunyili

    Recruiting

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

    Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu

    Liza C. Villaruz

    Recruiting

  • OSF Saint Francis Hospital and Medical Group

    Escanaba, Michigan, 49829

    Site Public Contact, 920-433-8889, WI_research_admin@hshs.org

    Matthew L. Ryan

    Recruiting

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Smilow Cancer Hospital Care Center-Fairfield

    Fairfield, Connecticut, 06824

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Michael J. Grant

    Recruiting

  • Thomas Hospital

    Fairhope, Alabama, 36532

    Site Public Contact, 251-435-4584

    Jan O. Kemnade

    Recruiting

  • University of Kansas Clinical Research Center

    Fairway, Kansas, 66205

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Anusha Chidharla

    Recruiting

  • Essentia Health Cancer Center-South University Clinic

    Fargo, North Dakota, 58103

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • UPMC Cancer Center at UPMC Horizon

    Farrell, Pennsylvania, 16121

    Site Public Contact, protocols@swog.org

    Liza C. Villaruz

    Recruiting

  • Cancer Hematology Centers - Flint

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Christopher M. Reynolds

    Recruiting

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

    Suspended

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Christopher M. Reynolds

    Recruiting

  • Kaiser Permanente-Fontana

    Fontana, California, 92335

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Eric C. McGary

    Recruiting

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Kaiser Permanente Fresno Orchard Plaza

    Fresno, California, 93720

    Site Public Contact, 833-574-2273

    Jennifer M. Suga

    Recruiting

  • Kaiser Permanente-Fresno

    Fresno, California, 93720

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Jennifer M. Suga

    Recruiting

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Charles W. Drescher

    Recruiting

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

    Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org

    Michael Humeniuk

    Recruiting

  • Malcom Randall Veterans Administration Medical Center

    Gainesville, Florida, 32610

    Site Public Contact, 352-273-8675, trials@cancer.ufl.edu

    Brittany K. Rogers

    Recruiting

  • Northeast Georgia Medical Center-Gainesville

    Gainesville, Georgia, 30501

    Site Public Contact, 770-219-8800, cancerpatient.navigator@nghs.com

    Charles H. Nash

    Recruiting

  • Kaiser Permanente-Gaithersburg Medical Center

    Gaithersburg, Maryland, 20879

    Site Public Contact, 240-632-4285, Charmaine.A.Mckie@kp.org

    James Liu

    Recruiting

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Young Kwang Chae

    Recruiting

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

    Site Public Contact, 877-441-7957

    Ikechukwu I. Akunyili

    Recruiting

  • Smilow Cancer Hospital Care Center at Glastonbury

    Glastonbury, Connecticut, 06033

    Suspended

  • Northwestern Medicine Glenview Outpatient Center

    Glenview, Illinois, 60026

    Site Public Contact, 312-695-1102

    Young Kwang Chae

    Recruiting

  • Addison Gilbert Hospital

    Gloucester, Massachusetts, 01930

    Site Public Contact, 978-283-4000 ext. 559

    Karl J. D'Silva

    Recruiting

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Northwestern Medicine Grayslake Outpatient Center

    Grayslake, Illinois, 60030

    Site Public Contact, 312-695-1102

    Young Kwang Chae

    Recruiting

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

    Site Public Contact, 920-433-8889, WI_research_admin@hshs.org

    Matthew L. Ryan

    Recruiting

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

    Site Public Contact, 920-433-8889, wi_research_admin@hshs.org

    Matthew L. Ryan

    Recruiting

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • UPMC Cancer Centers - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

    Site Public Contact, 724-838-1900

    Liza C. Villaruz

    Recruiting

  • Miami Valley Cancer Care and Infusion

    Greenville, Ohio, 45331

    Site Public Contact, 937-569-7515

    Tarek M. Sabagh

    Recruiting

  • Smilow Cancer Hospital Care Center at Greenwich

    Greenwich, Connecticut, 06830

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Michael J. Grant

    Recruiting

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

    Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org

    Michael Humeniuk

    Recruiting

  • Baptist Cancer Center-Grenada

    Grenada, Mississippi, 38901

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Wail Alnas

    Recruiting

  • Smilow Cancer Hospital Care Center - Guilford

    Guilford, Connecticut, 06437

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Michael J. Grant

    Recruiting

  • Gulfport Memorial Hospital

    Gulfport, Mississippi, 39502

    Site Public Contact, 504-210-3539, emede1@lsuhsc.edu

    Augusto C. Ochoa

    Recruiting

  • WellSpan Medical Oncology and Hematology

    Hanover, Pennsylvania, 17331

    Site Public Contact, 717-632-1559

    Ikechukwu I. Akunyili

    Recruiting

  • Kaiser Permanente South Bay

    Harbor City, California, 90710

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Eric C. McGary

    Recruiting

  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    Harrisburg, Pennsylvania, 17109

    Site Public Contact, 717-724-6765, klitchfield@PINNACLEHEALTH.org

    Liza C. Villaruz

    Recruiting

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

    Suspended

  • HaysMed

    Hays, Kansas, 67601

    Site Public Contact, 785-623-5774

    Anusha Chidharla

    Recruiting

  • Advocate South Suburban Hospital

    Hazel Crest, Illinois, 60429

    Site Public Contact, 708-799-9995

    Thomas J. Saphner

    Recruiting

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746

    Site Public Contact, 218-786-3308

    Bret E. Friday

    Recruiting

  • South Carolina Cancer Specialists PC

    Hilton Head Island, South Carolina, 29926-3827

    Site Public Contact, 912-819-5704, underberga@sjchs.org

    Mark A. Taylor

    Recruiting

  • Saint Mary Medical Center

    Hobart, Indiana, 46342

    Site Public Contact, 219-836-6875, CancerResearch@COMHS.org

    Tanmay Sahai

    Recruiting

  • Edwards Comprehensive Cancer Center

    Huntington, West Virginia, 25701

    Site Public Contact, 304-399-6566, Christina.Cole@chhi.org

    Toni O. Pacioles

    Recruiting

  • IRMC Cancer Center

    Indiana, Pennsylvania, 15701

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Liza C. Villaruz

    Recruiting

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

    Site Public Contact, 317-278-5632, iutrials@iu.edu

    Rohan Maniar

    Recruiting

  • Richard L. Roudebush Veterans Affairs Medical Center

    Indianapolis, Indiana, 46202

    Site Public Contact, 317-278-5632, iutrials@iu.edu

    Bharathi Muthusamy

    Recruiting

  • Sidney and Lois Eskenazi Hospital

    Indianapolis, Indiana, 46202

    Site Public Contact, 317-278-5632, iutrials@iu.edu

    Rohan Maniar

    Recruiting

  • Saint Catherine Hospital

    Indianapolis, Indiana, 46312

    Site Public Contact, protocols@swog.org

    Tanmay Sahai

    Recruiting

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

    Site Public Contact, 800-237-1225

    William A. Zeitler

    Recruiting

  • City of Hope at Irvine Lennar

    Irvine, California, 92618

    Site Public Contact, 877-467-3411

    Tanyanika L. Phillips

    Recruiting

  • Kaiser Permanente-Irvine

    Irvine, California, 92618

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Eric C. McGary

    Recruiting

  • Emory Johns Creek Hospital

    Johns Creek, Georgia, 30097

    Site Public Contact, 404-778-5714, m.lisa.hwang@emory.edu

    Jennifer W. Carlisle

    Recruiting

  • UPMC-Johnstown/John P. Murtha Regional Cancer Center

    Johnstown, Pennsylvania, 15901

    Site Public Contact, 814-534-4724

    Liza C. Villaruz

    Recruiting

  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

    Jonesboro, Arkansas, 72401

    Site Public Contact, 870-936-7066, Emily.Carvell@bmhcc.org

    Wail Alnas

    Recruiting

  • Logan Health Medical Center

    Kalispell, Montana, 59901

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Anusha Chidharla

    Recruiting

  • University Health Truman Medical Center

    Kansas City, Missouri, 64108

    Site Public Contact, 816-404-4375

    Anusha Chidharla

    Recruiting

  • University of Kansas Cancer Center - Briarcliff

    Kansas City, Missouri, 64116

    Site Public Contact, 913-588-3671

    Anusha Chidharla

    Recruiting

  • Kansas City Veterans Affairs Medical Center

    Kansas City, Missouri, 64128

    Site Public Contact, 800-525-1483

    Chao H. Huang

    Recruiting

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Anusha Chidharla

    Recruiting

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

    Site Public Contact, 608-775-2385, cancerctr@gundersenhealth.org

    Kurt Oettel

    Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

    Site Public Contact, 858-822-5354, cancercto@ucsd.edu

    Lyudmila A. Bazhenova

    Recruiting

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

    Site Public Contact, cancertrials@northwestern.edu

    Young Kwang Chae

    Recruiting

  • City of Hope Antelope Valley

    Lancaster, California, 93534

    Site Public Contact, 800-826-4673, becomingapatient@coh.org

    Tanyanika L. Phillips

    Recruiting

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

    Site Public Contact, 517-364-3712, harsha.trivedi@umhsparrow.org

    Christopher M. Reynolds

    Recruiting

  • Kaiser Permanente - Largo Medical Center

    Largo, Maryland, 20774

    Site Public Contact, 240-632-4285, Charmaine.A.Mckie@kp.org

    James Liu

    Recruiting

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

    Site Public Contact, 785-505-2800, Stephanie.Norris@LMH.ORG

    Anusha Chidharla

    Recruiting

  • Northside Hospital - Gwinnett

    Lawrenceville, Georgia, 30046

    Site Public Contact, 404-303-3355, Clinical.trials@northside.com

    I-wen Chang

    Recruiting

  • Cancer Centers of Southwest Oklahoma Research

    Lawton, Oklahoma, 73505

    Site Public Contact, 877-231-4440

    Abdul Rafeh Naqash

    Recruiting

  • Veteran Administration Eastern Kansas Healthcare

    Leavenworth, Kansas, 66048

    Suspended

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

    Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu

    Ivy L. Riano Monsalve

    Recruiting

  • Sechler Family Cancer Center

    Lebanon, Pennsylvania, 17042

    Site Public Contact, 717-741-8303, doxenberg@wellspan.org

    Ikechukwu I. Akunyili

    Recruiting

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Anusha Chidharla

    Recruiting

  • Markey Cancer Center at Lexington Clinic

    Lexington, Kentucky, 40504

    Site Public Contact, 859-257-3379

    Susanne M. Arnold

    Recruiting

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

    Site Public Contact, 859-257-3379

    Susanne M. Arnold

    Recruiting

  • AMG Libertyville - Oncology

    Libertyville, Illinois, 60048

    Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com

    Thomas J. Saphner

    Recruiting

  • Condell Memorial Hospital

    Libertyville, Illinois, 60048

    Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com

    Thomas J. Saphner

    Recruiting

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

    Site Public Contact, 909-558-4050

    Hamid R. Mirshahidi

    Recruiting

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Eric C. McGary

    Recruiting

  • Kaiser Permanente West Los Angeles

    Los Angeles, California, 90034

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Eric C. McGary

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Site Public Contact, 310-423-2133, Cancer.trial.info@cshs.org

    Karen L. Reckamp

    Recruiting

  • Kaiser Permanente Lutherville - Timonium Medical Center

    Lutherville, Maryland, 21093

    Site Public Contact, 240-632-4285, Charmaine.A.Mckie@kp.org

    James Liu

    Recruiting

  • Centra Alan B Pearson Regional Cancer Center

    Lynchburg, Virginia, 24501

    Site Public Contact, 434-200-1495, Kevin.Patel@centrahealth.com

    Renato G. Martins

    Recruiting

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    Madison, Wisconsin, 53718

    Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu

    Cheryl M. Czerlanis

    Recruiting

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

    Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu

    Cheryl M. Czerlanis

    Recruiting

  • Solinsky Center for Cancer Care

    Manchester, New Hampshire, 03103

    Site Public Contact, 800-339-6484

    Michael S. Buff

    Recruiting

  • OhioHealth Mansfield Hospital

    Mansfield, Ohio, 44903

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Zachary Trisel

    Recruiting

  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • OhioHealth Marion General Hospital

    Marion, Ohio, 43302

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Zachary Trisel

    Recruiting

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Adedayo A. Onitilo

    Recruiting

  • WVUH-Berkely Medical Center

    Martinsburg, West Virginia, 25401

    Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu

    Mohammed Almubarak

    Recruiting

  • Fremont - Rideout Cancer Center

    Marysville, California, 95901

    Site Public Contact, 530-749-4400

    Tianhong Li

    Recruiting

  • Mather Veteran Affairs Medical Center

    Mather, California, 95655

    Site Public Contact, protocols@swog.org

    Tianhong Li

    Recruiting

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

    Site Public Contact, 800-446-5532, Research@carle.com

    Tanmay Sahai

    Recruiting

  • Loyola University Medical Center

    Maywood, Illinois, 60153

    Site Public Contact, 708-226-4357

    Kathy S. Albain

    Recruiting

  • UPMC Cancer Center at UPMC McKeesport

    McKeesport, Pennsylvania, 15132

    Site Public Contact, 412-647-8073

    Liza C. Villaruz

    Recruiting

  • Kaiser Permanente Tysons Corner Medical Center

    McLean, Virginia, 22102

    Site Public Contact, 240-632-4285, Charmaine.A.Mckie@kp.org

    James Liu

    Recruiting

  • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

    Mechanicsburg, Pennsylvania, 17050

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Liza C. Villaruz

    Recruiting

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Wail Alnas

    Recruiting

  • Idaho Urologic Institute-Meridian

    Meridian, Idaho, 83642

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Charles W. Drescher

    Recruiting

  • Beebe South Coastal Health Campus

    Millville, Delaware, 19967

    Site Public Contact, 302-291-6730, research@beebehealthcare.org

    Gregory A. Masters

    Recruiting

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Community Medical Center

    Missoula, Montana, 59804

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36607

    Site Public Contact, 251-435-3942

    Jan O. Kemnade

    Recruiting

  • UPMC Hillman Cancer Center - Monroeville

    Monroeville, Pennsylvania, 15146

    Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu

    Liza C. Villaruz

    Recruiting

  • UPMC Hillman Cancer Center in Coraopolis

    Moon Township, Pennsylvania, 15108

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Liza C. Villaruz

    Recruiting

  • Virtua Samson Cancer Center

    Moorestown, New Jersey, 08057

    Site Public Contact, 856-206-4721, nctn@pennmedicine.upenn.edu

    Rachel S. Levenbach

    Recruiting

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

    Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu

    Mohammed Almubarak

    Recruiting

  • UPMC Hillman Cancer Center - Part of Frick Hospital

    Mount Pleasant, Pennsylvania, 15666

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Liza C. Villaruz

    Recruiting

  • The Community Hospital

    Munster, Indiana, 46321

    Site Public Contact, 219-836-3349

    Tanmay Sahai

    Recruiting

  • Women's Diagnostic Center - Munster

    Munster, Indiana, 46321

    Site Public Contact, 219-934-8869, mnicholson@comhs.org

    Tanmay Sahai

    Recruiting

  • Arnold Palmer Cancer Center Medical Oncology Norwin

    N. Huntingdon, Pennsylvania, 15642

    Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu

    Liza C. Villaruz

    Recruiting

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    Christopher M. Reynolds

    Recruiting

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83687

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Charles W. Drescher

    Recruiting

  • UPMC Cancer Center-Natrona Heights

    Natrona Heights, Pennsylvania, 15065

    Site Public Contact, 724-230-3030

    Liza C. Villaruz

    Recruiting

  • Baptist Memorial Hospital and Cancer Center-Union County

    New Albany, Mississippi, 38652

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Wail Alnas

    Recruiting

  • UPMC Hillman Cancer Center - New Castle

    New Castle, Pennsylvania, 16105

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Liza C. Villaruz

    Recruiting

  • Yale University

    New Haven, Connecticut, 06520

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Michael J. Grant

    Recruiting

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    David M. King

    Recruiting

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

    Suspended

  • Carle BroMenn Medical Center

    Normal, Illinois, 61761

    Site Public Contact, 800-446-5532, Research@Carle.com

    Tanmay Sahai

    Recruiting

  • Carle Cancer Institute Normal

    Normal, Illinois, 61761

    Site Public Contact, 800-446-5532, Research@Carle.com

    Tanmay Sahai

    Recruiting

  • Yale-New Haven Hospital North Haven Medical Center

    North Haven, Connecticut, 06473

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Michael J. Grant

    Recruiting

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • HSHS Saint Elizabeth's Hospital

    O'Fallon, Illinois, 62269

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Northwestern Medicine Oak Brook

    Oak Brook, Illinois, 60523

    Site Public Contact, nctnprogram_rhlccc@northwestern.edu

    Young Kwang Chae

    Recruiting

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453-2699

    Site Public Contact, 800-323-8622

    Thomas J. Saphner

    Recruiting

  • Advocate Outpatient Center - Oak Lawn

    Oak Lawn, Illinois, 60453

    Site Public Contact, ncorp@aah.org

    Thomas J. Saphner

    Recruiting

  • Kaiser Permanente-Oakland

    Oakland, California, 94611

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Jennifer M. Suga

    Recruiting

  • Saint Vincent Hospital Cancer Center at Oconto Falls

    Oconto Falls, Wisconsin, 54154

    Site Public Contact, 920-433-8889, WI_research_admin@hshs.org

    Matthew L. Ryan

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu

    Abdul Rafeh Naqash

    Recruiting

  • Integris Southwest Medical Center

    Oklahoma City, Oklahoma, 73109

    Suspended

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

    Site Public Contact, 405-752-3402

    Jay W. Carlson

    Recruiting

  • The University of Kansas Cancer Center - Olathe

    Olathe, Kansas, 66061

    Site Public Contact, 913-588-1569, OlatheCCResearch@kumc.edu

    Anusha Chidharla

    Recruiting

  • Kaiser Permanente-Ontario

    Ontario, California, 91761

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Eric C. McGary

    Recruiting

  • Saint Alphonsus Cancer Care Center-Ontario

    Ontario, Oregon, 97914

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    Christopher M. Reynolds

    Recruiting

  • Providence Willamette Falls Medical Center

    Oregon City, Oregon, 97045

    Suspended

  • Northwestern Medicine Orland Park

    Orland Park, Illinois, 60462

    Site Public Contact, nctnprogram_rhlccc@northwestern.edu

    Young Kwang Chae

    Recruiting

  • Lake Regional Hospital

    Osage Beach, Missouri, 65065

    Site Public Contact, 573-302-2768, clinicaltrials@lakeregional.com

    Jay W. Carlson

    Recruiting

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Anusha Chidharla

    Recruiting

  • University of Kansas Hospital-Indian Creek Campus

    Overland Park, Kansas, 66211

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Anusha Chidharla

    Recruiting

  • Baptist Memorial Hospital and Cancer Center-Oxford

    Oxford, Mississippi, 38655

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Wail Alnas

    Recruiting

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304

    Site Public Contact, 800-455-0057

    Harlan A. Pinto

    Recruiting

  • Advocate High Tech Medical Park

    Palos Heights, Illinois, 60463

    Site Public Contact, ncorp@aah.org

    Thomas J. Saphner

    Recruiting

  • Kaiser Permanente - Panorama City

    Panorama City, California, 91402

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Eric C. McGary

    Recruiting

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

    Site Public Contact, 847-384-3621

    Thomas J. Saphner

    Recruiting

  • Camden Clark Medical Center

    Parkersburg, West Virginia, 26101

    Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu

    Mohammed Almubarak

    Recruiting

  • Lahey Clinic Peabody

    Peabody, Massachusetts, 01960

    Site Public Contact, 781-744-3421, lhmc-cancer-clinical-trials@lahey.org

    Karl J. D'Silva

    Recruiting

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

    Site Public Contact, 215-349-8245, PMCancerResearch@pennmedicine.upenn.edu

    Corey J. Langer

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Site Public Contact, 215-728-4790

    Hossein Borghaei

    Recruiting

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

    Site Public Contact, 215-728-2983

    Hossein Borghaei

    Recruiting

  • OhioHealth Pickerington Methodist Hospital

    Pickerington, Ohio, 43147

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Zachary Trisel

    Recruiting

  • FirstHealth of the Carolinas-Moore Regional Hospital

    Pinehurst, North Carolina, 28374

    Site Public Contact, 910-715-3500, jcwilliams@firsthealth.org

    Charles S. Kuzma

    Recruiting

  • UPMC-Saint Margaret

    Pittsburgh, Pennsylvania, 15215

    Site Public Contact, 412-784-4900

    Liza C. Villaruz

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Site Public Contact, 412-647-8073

    Liza C. Villaruz

    Recruiting

  • UPMC-Passavant Hospital

    Pittsburgh, Pennsylvania, 15237

    Site Public Contact, 412-367-6454

    Liza C. Villaruz

    Recruiting

  • UPMC-Saint Clair Hospital Cancer Center

    Pittsburgh, Pennsylvania, 15243

    Site Public Contact, 412-502-3920

    Liza C. Villaruz

    Recruiting

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Suspended

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

    Suspended

  • Kaiser Permanente Northwest

    Portland, Oregon, 97227

    Site Public Contact, 503-335-2400, information@kpchr.org

    Abdul Hai Mansoor

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Site Public Contact, 503-494-1080, trials@ohsu.edu

    Jeremy P. Cetnar

    Recruiting

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Aurora Cancer Care-Racine

    Racine, Wisconsin, 53406

    Site Public Contact, 414-302-2304, ncorp@aurora.org

    Thomas J. Saphner

    Recruiting

  • Eisenhower Medical Center

    Rancho Mirage, California, 92270

    Suspended

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

    Site Public Contact, 605-755-2370, research@monument.health

    Abdel-Ghani Azzouqa

    Recruiting

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

    Site Public Contact, 302-291-6730, research@beebehealthcare.org

    Gregory A. Masters

    Recruiting

Other trials in United States

About this study

Official title: A Randomized Phase II/III Study of Docetaxel and Ramucirumab With or Without Cemiplimab for Participants Previously Treated With Platinum-Based Chemotherapy and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)

This phase II/III Expanded Lung-MAP treatment trial compares the effect of adding cemiplimab to docetaxel and ramucirumab versus docetaxel and ramucirumab alone in treating patients with non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Cemiplimab is a monoclonal antibody that stimulates the immune system by blocking the PD-1 pathway. Tumors use the PD-1 pathway to escape attacks from the immune system. By blocking the PD-1 pathway, cemiplimab may help the immune system recognize and attack tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Adding cemiplimab to usual treatment, docetaxel and ramucirumab, may kill more tumor cells compared to docetaxel and ramucirumab alone in treating patients with stage IV or recurrent non-small cell lung cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To compare overall survival (OS) between participants randomized to docetaxel and ramucirumab with or without cemiplimab (REGN2810) who have acquired resistance to platinum-based chemotherapy and immunotherapy for stage IV or recurrent non-small cell lung cancer (NSCLC).

SECONDARY OBJECTIVES:

  1. To compare investigator-assessed progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 between the arms.

II. To compare investigator-assessed response rates (confirmed or unconfirmed, complete response [CR] or partial response [PR]) per RECIST 1.1 between the arms among participants with measurable disease.

III. To compare the investigator-assessed disease control rate (confirmed or unconfirmed, complete response [CR], or partial response [PR], and stable disease) between the arms.

IV. To evaluate the duration of response (DoR) among responders within each arm.

  1. To evaluate the frequency and severity of toxicities within each arm. VI. To compare investigator-assessed PFS between the arms within the subgroups defined by the stratification factors (histology and performance status) and by PD-L1 subgroups defined as PD-L1 negative (< 1% tumor proportion score [TPS]), intermediate PD-L1 (1-49% TPS), and PD-L1 high (>= 50% TPS).

VII. To compare OS between the arms within the subgroups defined by the stratification factors (histology and performance status) and by PD-L1 subgroups defined as PD-L1 negative (< 1% TPS), intermediate PD-L1 (1-49% TPS), and PD-L1 high (>= 50% TPS).

TRANSLATIONAL MEDICINE OBJECTIVES:

  1. To collect, process, and bank cell-free deoxyribonucleic acid (cfDNA) at baseline, cycle 3 day 1, and progression for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor DNA (ctDNA).

II. To establish a tissue/blood repository to pursue future studies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive dexamethasone orally (PO) twice daily (BID) on days 0-2, ramucirumab intravenously (IV) over 30-60 minutes on day 1 and docetaxel IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, and computed tomography (CT) or magnetic resonance imaging (MRI) throughout the study.

ARM II: Patients receive dexamethasone PO BID on days 0-2, ramucirumab IV over 30-60 minutes on day 1, docetaxel IV over 60 minutes on day 1, and cemiplimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, and CT or MRI throughout the study.

After completion of study treatment, patients are followed up every 3-6 months for up to 3 years after randomization.

Being tested
Biospecimen Collection, Cemiplimab, Computed Tomography, Dexamethasone, Docetaxel
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • CemiplimabBiological

    Also called Cemiplimab RWLC, Cemiplimab-rwlc, Libtayo, REGN 2810

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • DexamethasoneDrug

    Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex

    Given PO

  • DocetaxelDrug

    Also called Docecad, RP 56976, RP-56976, RP56976

    Given IV

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • RamucirumabBiological

    Also called Anti-VEGFR-2 Fully Human Monoclonal Antibody IMC-1121B, Cyramza, IMC 1121B, IMC-1121B

    Given IV

Study groups in NCT06616584
Study groupRoleWhat they receive
Arm I (ramucirumab, docetaxel)Active comparatorPatients receive dexamethasone PO BID on days 0-2, ramucirumab IV over 30-60 minutes on day 1 and docetaxel IV over 60 minutes on day 1 of each cycle (each cycle is 21 days). Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, and CT or MRI throughout the study.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Dexamethasone; Drug: Docetaxel; Procedure: Magnetic Resonance Imaging; Biological: Ramucirumab
Arm II (cemiplimab, ramucirumab, docetaxel)ExperimentalPatients receive dexamethasone PO BID on days 0-2, ramucirumab IV over 30-60 minutes on day 1, docetaxel IV over 60 minutes on day 1, and cemiplimab IV over 30 minutes on day 1 of each cycle (each cycle is 21 days). Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, and CT or MRI throughout the study.
Receives: Procedure: Biospecimen Collection; Biological: Cemiplimab; Procedure: Computed Tomography; Drug: Dexamethasone; Drug: Docetaxel; Procedure: Magnetic Resonance Imaging; Biological: Ramucirumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    OS will be compared between arms and within the subgroups defined by the stratification factors and by PD-L1 subgroups. Distributions of OS will be estimated using the method of Kaplan-Meier. Hazard ratios for comparisons of OS will be estimated using a Cox Proportional Hazards regression model, with baseline hazard stratification using the stratification factors. Testing will be done using a stratified log-rank test. Confidence intervals (CIs) about medians will be estimated using the method of Brookmeyer-Crowley. For point estimates at landmark times, the associated CIs will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function.

    Measured: From date of randomization to date of death due to any cause, assessed up to 3 years

Secondary outcomes (5)

  1. Progression-free survival (PFS)

    PFS will be compared between arms and within the subgroups defined by the stratification factors and by PD-L1 subgroups. PFS between the arms will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Distributions of PFS will be estimated using the method of Kaplan-Meier. Hazard ratios for comparisons of PFS will be estimated using a Cox Proportional Hazards regression model, with baseline hazard stratification using the stratification factors. Testing will be done using a stratified log-rank test. CIs about medians will be estimated using the method of Brookmeyer-Crowley. For point estimates at landmark times, the associated CIs will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function.

    Measured: From date of randomization to date of first documentation of progression, symptomatic deterioration, or death, whichever comes first, assessed up to 3 years

  2. Response rates

    Response rates (complete response [CR] or partial response [PR]) between the arms will be assessed per RECIST 1.1. Binary proportions along with confidence intervals will be estimated for response. CIs will be estimated using the Wilson Score method with continuity correction.

    Measured: Up to 3 years

  3. Disease control rates

    Disease control rates (CR or PR and stable disease) between the arms. Binary proportions along with confidence intervals will be estimated for disease control rate. CIs will be estimated using the Wilson Score method with continuity correction.

    Measured: Up to 3 years

  4. Duration of response (DOR)

    Will be assessed among participants who achieve a response. Distributions of DOR will be estimated using the method of Kaplan-Meier.

    Measured: From date of first documentation of response by RECIST 1.1 (CR or PR, confirmed or unconfirmed) to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years

  5. Incidence of adverse events

    Adverse events will be assessed and graded using Common Terminology Criteria for Adverse Events version 5.0. Individual toxicities within each treatment arm will be summarized by grade, among those reported as being attributable to treatment (possibly, probably, or definitely attributable to treatment). The frequency and severity for each adverse event term will be summarized for grade 3, 4 and 5 separately, and as worst grade reported overall all reported adverse events.

    Measured: Up to 90 days after last dose of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2024
  2. Study start22 May 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
378 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06616584
Sponsor's protocol ID
S1800E
Other IDs
NCI-2024-06444, S1800E, S1800E, U10CA180888
Status last verified
Oct 2026
First submitted
27 Aug 2024
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Biospecimen Collection, Cemiplimab and Computed Tomography in people with Recurrent Lung Non-Small Cell Carcinoma and Stage IV Lung Cancer AJCC v8, run by SWOG Cancer Research Network at 413 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 52 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 413 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jennifer Beeler (210-614-8808, jbeeler@swog.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: From date of randomization to date of death due to any cause, assessed up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06616584.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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