AzTrials
AzTrials

Recurrent Lung Non-Small Cell CarcinomaPhase 2NCT04268550

Targeted Treatment for RET Fusion-Positive Advanced Non-Small Cell Lung Cancer (A LUNG-MAP Treatment Trial)

A Phase 2 study testing Selpercatinib in people with Recurrent Lung Non-Small Cell Carcinoma and Stage IV Lung Cancer AJCC v8, run by SWOG Cancer Research Network at 306 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This phase II LUNG-MAP treatment trial studies how well selpercatinib works in treating patients with RET fusion-positive non-small cell lung cancer that is stage IV or has come back (recurrent). Selpercatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Any age
What is being tested?
Selpercatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
306 sitesUnited States
Study dates
8 Apr 2020to 1 Dec 2026
Phase
Phase 2
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients must have been assigned to S1900B based on biomarker analysis of tissue and/or blood and determined to have RET fusion-positive NSCLC as defined here:
  • Patients must have RET fusion-positive NSCLC as determined by the Foundation Medicine (FMI) tissue-assay, other tumor-based assays such as next-generation sequencing (NGS), polymerase chain reaction (PCR), or follicular in situ hybridization (FISH), or by cfDNA blood assay. Patients with RET fusions detected by immunohistochemistry (IHC) alone are not eligible. The testing must be done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO/International Electrotechnical Commission (IEC), College of American Pathologists (CAP), or similar certification. Presence of RET fusions detected on tests performed outside of LUNGMAP must have been confirmed by the study biomarker review panel
  • For patients whose prior therapy was for stage IV or recurrent disease, the patient must have received at least one line of a platinum-based chemotherapy regimen. For patients whose prior systemic therapy was for stage I-III disease only (i.e. patient has not received any treatment for stage IV or recurrent disease), disease progression on platinum-based chemotherapy must have occurred within one year from the last date that the patient received that therapy. Prior anti-PD-1/PD-L1 therapy, alone or in combination (e.g. nivolumab, pembrolizumab, or durvalumab) is allowed
  • Patients must be negative for all additional validated oncogenic drivers that could cause resistance to LOXO-292 treatment. This includes EGFR sensitizing mutations, EGFR T790M, ALK gene fusion, ROS1 gene fusion, KRAS activating mutation, BRAF V600E mutation and MET exon 14 skipping mutation or high-level amplification and expression
  • Note: EGFR, ALK, ROS, KRAS, and BRAF testing is performed as part of the LUNGMAP screening/pre-screening FoundationOne test. If prior data is not available, results from the FMI testing must be obtained prior to sub-study registration
  • Patients must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (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 sub-study registration. 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 sub-study registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form. Patients 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. CT and MRI scans must be submitted for central review via transfer of images and data (TRIAD)
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  • Patients must have a CT or MRI scan of the brain to evaluate for CNS disease within 42 days prior to sub-study registration
  • Patients with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment must have an undetectable HCV viral load within 28 days prior to registration
  • Patients 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 registration
  • Patients must be able to swallow capsules
  • Patients must have progressed (in the opinion of the treating physician) following the most recent line of therapy
  • Patients must have recovered (=< grade 1) from any side effects of prior therapy. Patients must not have received any radiation therapy within 14 days prior to sub-study registration
  • Absolute neutrophil count (ANC) >= 1,500/mcl (obtained within 28 days prior to sub-study registration)
  • Platelet count >= 100,000 mcl (obtained within 28 days prior to sub-study registration)
  • Serum bilirubin =< institutional upper limit of normal (IULN) (within 28 days prior to sub-study registration). For patients with liver metastases, bilirubin must be =< 5 x IULN
  • Either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 2 x IULN (within 28 days prior to sub-study registration) (if both ALT and AST are done, both must be =< 2 IULN). For patients with liver metastases, bilirubin and either ALT or AST must be =< 5 x IULN (if both ALT and AST are done, both must be =< 5 x IULN)
  • Serum creatinine =< the IULN or calculated creatinine clearance >= 50 mL/min using the following Cockcroft-Gault formula (within 28 days prior to sub-study registration)
  • Patients must have Zubrod performance status 0-1 documented within 28 days prior to sub-study registration
  • Pre-study history and physical exam must be obtained within 28 days prior to sub-study registration
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
  • Patients must have electrolytes and blood urea nitrogen (BUN) performed within 14 days prior to sub-study registration
  • Patients must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)
  • Patients must also be offered participation in banking and in the correlative studies for collection and future use of specimens
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • 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
  • Patients with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)

Who cannot join

  • Patients must not have received any prior treatment with selective anti-RET inhibitors (anti-RET multikinase inhibitors are permitted)
  • Patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to registration, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to sub-study registration
  • Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 14 days prior to sub-study registration
  • Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study. Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable
  • Patient must not have had a major surgery within 14 days prior to sub-study registration. Patient must have fully recovered from the effects of prior surgery in the opinion of the treating investigator
  • Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients 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, or serious uncontrolled cardiac arrhythmia
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  • Patients must not have a QT interval by Fridericia (QTcF) > 470 msec based on the electrocardiogram (ECG) within 28 days prior to registration. It is suggested that a local cardiologist review the QTcF intervals
  • Patients must not have any clinically significant uncontrolled systemic illness, including but not limited to uncontrolled infection, requiring intravenous antibiotics, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmias, uncontrolled hypertension, or uncontrolled diabetes mellitus
  • Uncontrolled diabetes: Patients who have a diagnosis of diabetes must have an hemoglobin (Hb) A1C < 7% within 28 days prior to registration. The same criterion will be used in patients with confirmed diagnosis of diabetes mellitus who have been on a stable dietary or therapeutic regimen for this condition in the last three months
  • Uncontrolled blood pressure and hypertension: All blood pressure measurements within the 28 days prior to registration must be systolic blood pressure (SBP) =< 180 and diastolic blood pressure (DBP) =< 100. An exception can be made by a healthcare provider for a patient with a single blood pressure elevation who upon rechecking has a blood pressure within the parameters above
  • Patients must not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of LOXO-292 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or active peptic ulcer disease)
  • Patients must not be planning to receive any strong inhibitors or inducers of CYP3A4 at least 14 days prior to sub-study registration and throughout protocol treatment
  • Patients must not be planning to use proton pump inhibitors (PPIs) at least one week prior to sub-study registration and throughout protocol treatment
  • Patients must not be pregnant or nursing. Women study patients of reproductive potential and fertile men study patients and their partners must abstain or use effective contraception (including barrier method) while receiving study treatment and for at least 3 months after the last dose of LOXO-292. Male study patients must agree not to donate sperm for 6 months after the last dose of LOXO-292. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures

Trial locations and contacts

306 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Hawaii Cancer Care - Savio

    ‘Aiea, Hawaii, 96701

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • New Mexico Oncology Hematology Consultants

    Albuquerque, New Mexico, 87109

  • Presbyterian Kaseman Hospital

    Albuquerque, New Mexico, 87110

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic PC - Ames

    Ames, Iowa, 50010

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Langlade Hospital and Cancer Center

    Antigo, Wisconsin, 54409

  • Randolph Hospital

    Asheboro, North Carolina, 27203

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Sutter Auburn Faith Hospital

    Auburn, California, 95602

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Mount Sinai Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

  • Kaiser Permanente-Baldwin Park

    Baldwin Park, California, 91706

  • Medical Center of Baton Rouge

    Baton Rouge, Louisiana, 70816

  • Ochsner High Grove

    Baton Rouge, Louisiana, 70836

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122

  • Waldo County General Hospital

    Belfast, Maine, 04915

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford

    Biddeford, Maine, 04005

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Saint Luke's Mountain States Tumor Institute

    Boise, Idaho, 83712

  • McFarland Clinic PC-Boone

    Boone, Iowa, 50036

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Northeast Georgia Medical Center Braselton

    Braselton, Georgia, 30517

  • IHA Hematology Oncology Consultants-Brighton

    Brighton, Michigan, 48114

  • Saint Joseph Mercy Brighton

    Brighton, Michigan, 48114

  • Cone Health Cancer Center at Alamance Regional

    Burlington, North Carolina, 27215

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • IHA Hematology Oncology Consultants-Canton

    Canton, Michigan, 48188

  • Saint Joseph Mercy Canton

    Canton, Michigan, 48188

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Rex Hematology Oncology Associates-Cary

    Cary, North Carolina, 27518

  • Geauga Hospital

    Chardon, Ohio, 44024

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • IHA Hematology Oncology Consultants-Chelsea

    Chelsea, Michigan, 48118

  • Saint Joseph Mercy Chelsea

    Chelsea, Michigan, 48118

  • Northwestern University

    Chicago, Illinois, 60611

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Doctors Hospital

    Columbus, Ohio, 43228

  • New Hampshire Oncology Hematology PA-Concord

    Concord, New Hampshire, 03301

  • Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • Western Maryland Regional Medical Center

    Cumberland, Maryland, 21502

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Genesis Medical Center - East Campus

    Davenport, Iowa, 52803

  • Genesis Cancer Care Institute

    Davenport, Iowa, 52804

  • Iowa Cancer Specialists

    Davenport, Iowa, 52807

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

  • Bayhealth Hospital Kent Campus

    Dover, Delaware, 19901

  • Northside Hospital - Duluth

    Duluth, Georgia, 30096

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Durham VA Medical Center

    Durham, North Carolina, 27705

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Fox Chase Cancer Center - East Norriton Hospital Outpatient Center

    East Norriton, Pennsylvania, 19401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Arnot Ogden Medical Center/Falck Cancer Center

    Elmira, New York, 14905

  • Ephrata Cancer Center

    Ephrata, Pennsylvania, 17522

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • Genesee Cancer and Blood Disease Treatment Center

    Flint, Michigan, 48503

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Kaiser Permanente-Fontana

    Fontana, California, 92335

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Cancer Care and Hematology-Fort Collins

    Fort Collins, Colorado, 80528

  • McFarland Clinic PC-Trinity Cancer Center

    Fort Dodge, Iowa, 50501

  • Parkview Regional Medical Center

    Fort Wayne, Indiana, 46845

  • Palo Alto Medical Foundation-Fremont

    Fremont, California, 94538

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

  • Northeast Georgia Medical Center-Gainesville

    Gainesville, Georgia, 30501

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Rex Hematology Oncology Associates-Garner

    Garner, North Carolina, 27529

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois, 60026

  • Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • UCHealth Greeley Hospital

    Greeley, Colorado, 80631

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Cherry Tree Cancer Center

    Hanover, Pennsylvania, 17331

  • Kaiser Permanente - Harbor City

    Harbor City, California, 90710

  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    Harrisburg, Pennsylvania, 17109

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • HaysMed University of Kansas Health System

    Hays, Kansas, 67601

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746

  • NorthShore University HealthSystem-Highland Park Hospital

    Highland Park, Illinois, 60035

  • UCHealth Highlands Ranch Hospital

    Highlands Ranch, Colorado, 80129

  • Hawaii Cancer Care Inc-POB II

    Honolulu, Hawaii, 96813

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

  • Edwards Comprehensive Cancer Center

    Huntington, West Virginia, 25701

  • Franciscan Health Indianapolis

    Indianapolis, Indiana, 46237

  • Kaiser Permanente-Irvine

    Irvine, California, 92618

  • Allegiance Health

    Jackson, Michigan, 49201

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • McFarland Clinic PC-Jefferson

    Jefferson, Iowa, 50129

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Truman Medical Centers

    Kansas City, Missouri, 64108

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

  • Ochsner Medical Center Kenner

    Kenner, Louisiana, 70065

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • OptumCare Cancer Care at Oakey

    Las Vegas, Nevada, 89102

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada, 89148

  • Northside Hospital - Gwinnett

    Lawrenceville, Georgia, 30046

  • Sechler Family Cancer Center

    Lebanon, Pennsylvania, 17042

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Rocky Mountain Cancer Centers-Littleton

    Littleton, Colorado, 80120

  • Hope Cancer Clinic

    Livonia, Michigan, 48154

  • Saint Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Rocky Mountain Cancer Centers-Sky Ridge

    Lone Tree, Colorado, 80124

  • UCHealth Lone Tree Health Center

    Lone Tree, Colorado, 80124

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Kaiser Permanente-Cadillac

    Los Angeles, California, 90034

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Solinsky Center for Cancer Care

    Manchester, New Hampshire, 03103

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143

  • OhioHealth Marion General Hospital

    Marion, Ohio, 43302

  • McFarland Clinic PC-Marshalltown

    Marshalltown, Iowa, 50158

  • UH Seidman Cancer Center at Landerbrook Health Center

    Mayfield Heights, Ohio, 44124

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Bon Secours Memorial Regional Medical Center

    Mechanicsville, Virginia, 23116

  • Aspirus Medford Hospital

    Medford, Wisconsin, 54451

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • UH Seidman Cancer Center at Southwest General Hospital

    Middleburg Heights, Ohio, 44130

  • Bon Secours Saint Francis Medical Center

    Midlothian, Virginia, 23114

  • Bayhealth Hospital Sussex Campus

    Milford, Delaware, 19963

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • Minneapolis VA Medical Center

    Minneapolis, Minnesota, 55417

  • Virtua Samson Cancer Center

    Moorestown, New Jersey, 08057

  • Franciscan Health Mooresville

    Mooresville, Indiana, 46158

  • Palo Alto Medical Foundation-Camino Division

    Mountain View, California, 94040

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83686

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

  • Licking Memorial Hospital

    Newark, Ohio, 43055

  • University of Kansas Cancer Center at North Kansas City Hospital

    North Kansas City, Missouri, 64116

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

  • Olathe Health Cancer Center

    Olathe, Kansas, 66061

  • Kaiser Permanente-Ontario

    Ontario, California, 91761

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210

  • Palo Alto Medical Foundation Health Care

    Palo Alto, California, 94301

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304

  • Kaiser Permanente - Panorama City

    Panorama City, California, 91402

  • University Hospitals Parma Medical Center

    Parma, Ohio, 44129

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232

  • Jefferson Healthcare

    Port Townsend, Washington, 98368

  • Kaiser Permanente Northwest

    Portland, Oregon, 97227

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Southern Ohio Medical Center

    Portsmouth, Ohio, 45662

  • Pottstown Hospital

    Pottstown, Pennsylvania, 19464

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Aurora Cancer Care-Racine

    Racine, Wisconsin, 53406

  • Rex Cancer Center

    Raleigh, North Carolina, 27607

  • Rex Hematology Oncology Associates-Blue Ridge

    Raleigh, North Carolina, 27607

  • Rex Cancer Center of Wakefield

    Raleigh, North Carolina, 27614

  • University Hospitals Portage Medical Center

    Ravenna, Ohio, 44266

  • Spectrum Health Reed City Hospital

    Reed City, Michigan, 49677

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • Bon Secours Saint Mary's Hospital

    Richmond, Virginia, 23226

  • Presbyterian Rust Medical Center/Jorgensen Cancer Center

    Rio Rancho, New Mexico, 87124

  • Kaiser Permanente-Riverside

    Riverside, California, 92505

  • University of Rochester

    Rochester, New York, 14642

  • Penobscot Bay Medical Center

    Rockport, Maine, 04856

  • Sutter Roseville Medical Center

    Roseville, California, 95661

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Ascension Saint Mary's Hospital

    Saginaw, Michigan, 48601

  • Oncology Hematology Associates of Saginaw Valley PC

    Saginaw, Michigan, 48604

  • Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

  • Salem Hospital

    Salem, Oregon, 97301

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • Kaiser Permanente-San Diego Zion

    San Diego, California, 92120

  • California Pacific Medical Center-Pacific Campus

    San Francisco, California, 94115

  • Kaiser Permanente-San Marcos

    San Marcos, California, 92078

  • Essentia Health Sandstone

    Sandstone, Minnesota, 55072

  • UH Seidman Cancer Center at Firelands Regional Medical Center

    Sandusky, Ohio, 44870

  • MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford

    Sanford, Maine, 04073

  • Palo Alto Medical Foundation-Santa Cruz

    Santa Cruz, California, 95065

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081

  • Genesis Cancer Center - Silvis

    Silvis, Illinois, 61282

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Suburban Hematology Oncology Associates - Snellville

    Snellville, Georgia, 30078

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Maine Medical Partners - South Portland

    South Portland, Maine, 04106

  • Prisma Health Cancer Institute - Spartanburg

    Spartanburg, South Carolina, 29307

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Mercy Hospital South

    St Louis, Missouri, 63128

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Missouri Baptist Sullivan Hospital

    Sullivan, Missouri, 63080

  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066

  • Palo Alto Medical Foundation-Sunnyvale

    Sunnyvale, California, 94086

  • Missouri Baptist Outpatient Center-Sunset Hills

    Sunset Hills, Missouri, 63127

  • ProMedica Flower Hospital

    Sylvania, Ohio, 43560

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Ascension Saint Joseph Hospital

    Tawas City, Michigan, 48764

  • James J Peters VA Medical Center

    The Bronx, New York, 10468

  • University of Kansas Health System Saint Francis Campus

    Topeka, Kansas, 66606

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Saint Luke's Cancer Institute - Twin Falls

    Twin Falls, Idaho, 83301

  • Vince Lombardi Cancer Clinic-Two Rivers

    Two Rivers, Wisconsin, 54241

  • Sutter Solano Medical Center/Cancer Center

    Vallejo, California, 94589

  • Essentia Health Virginia Clinic

    Virginia, Minnesota, 55792

  • Virtua Voorhees

    Voorhees Township, New Jersey, 08043

  • University Hospitals Sharon Health Center

    Wadsworth, Ohio, 44281

  • Aspirus Regional Cancer Center

    Wausau, Wisconsin, 54401

  • Aurora Cancer Care-Milwaukee West

    Wauwatosa, Wisconsin, 53226

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

  • Froedtert West Bend Hospital/Kraemer Cancer Center

    West Bend, Wisconsin, 53095

  • Mercy Medical Center-West Lakes

    West Des Moines, Iowa, 50266

  • Veterans Affairs Connecticut Healthcare System-West Haven Campus

    West Haven, Connecticut, 06516

  • UH Seidman Cancer Center at Saint John Medical Center

    Westlake, Ohio, 44145

  • UHHS-Westlake Medical Center

    Westlake, Ohio, 44145

  • Marshfield Clinic - Weston Center

    Weston, Wisconsin, 54476

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205

  • Presbyterian Intercommunity Hospital

    Whittier, California, 90602

  • UPMC Susquehanna

    Williamsport, Pennsylvania, 17701

  • Aspirus UW Cancer Center

    Wisconsin Rapids, Wisconsin, 54494

Other trials in United States

About this study

Official title: A Phase II Study of LOXO-292 in Patients With RET Fusion-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP Sub-Study)

This phase II LUNG-MAP treatment trial studies how well selpercatinib works in treating patients with RET fusion-positive non-small cell lung cancer that is stage IV or has come back (recurrent). Selpercatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the objective response rate (ORR) (confirmed complete or partial response) by blinded independent centralized review (BICR) associated with selpercatinib (LOXO-292) in patients with previously-treated stage IV or recurrent RET fusion-positive non-small cell lung cancer (NSCLC).

SECONDARY OBJECTIVES:

  1. To evaluate the duration of BICR-assessed response among BICR responders. II. To evaluate the frequency and severity of toxicities. III. To evaluate the investigator-assessed objective response rate (confirmed complete or partial response).

IV. To evaluate duration of investigator-assessed response among patients with a response as determined by the local investigator.

  1. To evaluate investigator-assessed progression-free survival (IA-PFS). VI. To evaluate BICR-assessed PFS. VII. To evaluate overall survival (OS).

VIII. Among patients with brain metastases at baseline:

VIIIa. To evaluate the central nervous system (CNS) response rate (confirmed complete response [CR]).

VIIIb. To evaluate the duration of intracranial response among patients with a CNS response.

TRANSLATIONAL MEDICINE OBJECTIVES:

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

II. To establish a tissue/blood repository from patients with refractory non-small cell lung cancer (NSCLC).

OUTLINE:

Patients receive selpercatinib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 2 years and then at the end of 3 years from date of sub-study registration.

Being tested
Selpercatinib
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.

  • SelpercatinibDrug

    Also called LOXO-292, RET Kinase Inhibitor LOXO-292

    Given PO

Study groups in NCT04268550
Study groupRoleWhat they receive
Treatment (selpercatinib)ExperimentalPatients receive selpercatinib orally PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Selpercatinib

What is being measured

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

  1. Response rate by blinded independent centralized review (BICR)

    A response will be confirmed by a complete response (CR) or partial response (PR). Proportions and associated confidence intervals will be calculated.

    Measured: Up to 3 years from date of sub-study registration

Secondary outcomes (7)

  1. Incidence of adverse events

    Will be assessed using Common Terminology Criteria for Adverse Event version 5.0.

    Measured: Up to 3 years from date of sub-study registration

  2. BICR-progression-free survival (PFS)

    Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to estimate confidence intervals for the median using Greenwood's formula and based on a log-log transformation applied on the survival function for landmark times

    Measured: From date of sub-study registration to date of first documentation of progression assessed by BICR or symptomatic deterioration, or death due to any cause, assessed up to 3 years from date of sub-study registration

  3. Investigator-assessed (IA) PFS

    Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to estimate confidence intervals for the median using Greenwood's formula and based on a log-log transformation applied on the survival function for landmark times

    Measured: From date of sub-study registration to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 3 years from date of sub-study registration

  4. Overall survival

    Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to estimate confidence intervals for the median using Greenwood's formula and based on a log-log transformation applied on the survival function for landmark times

    Measured: Up to 3 years from date of sub-study registration

  5. BICR-duration of response (DOR)

    Will be evaluated among patients who achieve a confirmed response. Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to estimate confidence intervals for the median using Greenwood's formula and based on a log-log transformation applied on the survival function for landmark times. The median DOR and percentage with DOR at landmark times at 6 and 12 months after documentation of confirmed response will be estimated.

    Measured: From date of first documentation of confirmed response (CR or PR) to date of first documentation of progression assessed by BICR or symptomatic deterioration, or death due to any cause among patients who achieve, assessed at 6 and 12 months

  6. Central nervous system (CNS) response rate

    Will be assessed among patients with brain metastases. Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to estimate confidence intervals for the median using Greenwood's formula and based on a log-log transformation applied on the survival function for landmark times

    Measured: Baseline

  7. Duration of intracranial response among patients with a CNS response

    Will be assessed among patients with brain metastases. Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to estimate confidence intervals for the median using Greenwood's formula and based on a log-log transformation applied on the survival function for landmark times

    Measured: Baseline

Timeline

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

  1. First posted13 Feb 2020
  2. Study start8 Apr 2020
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2026 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
124 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04268550
Sponsor's protocol ID
S1900B
Other IDs
NCI-2019-08097, S1900B, S1900B, U10CA180888
Status last verified
Mar 2026
First submitted
8 Jan 2020
Last updated
23 Mar 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 study testing Selpercatinib in people with Recurrent Lung Non-Small Cell Carcinoma and Stage IV Lung Cancer AJCC v8, run by SWOG Cancer Research Network at 306 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 27 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 306 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 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.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate by blinded independent centralized review (BICR) (time frame: Up to 3 years from date of sub-study registration). 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 NCT04268550.

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 23 Mar 2026.

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