AzTrials
AzTrials

Lung Non-Small Cell CarcinomaPhase 2NCT05364645

Testing the Use of Targeted Treatment for RET Positive Advanced Non-small Cell Lung Cancer

A Phase 2 study testing Carboplatin, Pemetrexed and Selpercatinib in people with Lung Non-Small Cell Carcinoma and Recurrent Lung Non-Small Cell Carcinoma, run by SWOG Cancer Research Network at 265 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase II Lung-MAP treatment trial tests whether carboplatin and pemetrexed with or without selpercatinib works to shrink tumors in patients with RET fusion-positive non-small cell lung cancer that is stage IV or has not responded to previous RET directed therapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Carboplatin, Pemetrexed and Selpercatinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
265 sitesUnited States
Study dates
25 Jul 2022to 1 May 2029
Phase
Phase 2
Are there results?
None posted in the registry

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 stage IV or recurrent disease
  • Participants must have been assigned to S1900F based on biomarker analysis of tissue and/or blood and determined to have RET fusion-positive NSCLC as defined here:
  • Participants must have RET fusion-positive NSCLC as determined by the Foundation Medicine (FMI) tissue-assay or other tumor-based assays such as next generation sequencing (NGS), polymerase chain reaction (PCR), or fluorescent in situ hybridization (FISH), or by cfDNA blood assay as outlined in the LUNGMAP Screening Protocol. Participants previously tested for and determined to have RET-fusion-positive NSCLC outside of LUNGMAP, must also submit tissue for central FMI testing on the LUNGMAP Screening Protocol. Participants with RET fusions detected by 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
  • Participants must be negative for all additional validated oncogenic drivers that could cause resistance to selpercatinib treatment. This includes EGFR sensitizing mutations, EGFR T790M mutations, ALK gene fusions, ROS1 gene fusion, KRAS activating mutations, BRAF V600E mutation and MET exon 14 skipping mutations 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 randomization.
  • Participants 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 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 sub-study 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 randomization
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  • Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study randomization
  • Participants must have received and developed disease progression during or after an anti-RET inhibitors treatment. The anti-RET inhibitor therapy must be the most recent therapy
  • Participants must have progressed (in the opinion of the treating physician) following the most recent line of therapy
  • Participants must have recovered (=< grade 1) from any side effects of prior therapy. Participants must not have received any radiation therapy within 14 days prior to sub-study randomization
  • For participants with stage IV or recurrent disease, the participant must not have received a platinum-based chemotherapy regimen. For participants whose prior systemic therapy was for stage I-III disease only (i.e., participant has not received any treatment for stage IV or recurrent disease), disease progression on platinum-based chemotherapy must not have occurred within one year (365 days) from the last date that the participant received that therapy. Prior anti-PD-1/PD-L1 therapy, alone or in combination (e.g., nivolumab, pembrolizumab, or durvalumab) is allowed
  • Participants must have an electrocardiogram (ECG) performed within 28 days prior to sub-study randomization. It is suggested that a local cardiologist review the corrected QT by Fridericia's correction formula (QTcF) intervals
  • Absolute neutrophil count (ANC) >= 1.5 x 10^3/uL obtained within 28 days prior to sub-study randomization
  • Platelet count >= 100 x 10^3/uL obtained within 28 days prior to sub-study randomization
  • Hemoglobin >= 9 g/dL obtained within 28 days prior to sub-study randomization
  • Serum bilirubin =< institutional upper limit of normal (IULN) and either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 2 x IULN within 28 days prior to sub-study randomization (if both ALT and AST are done, both must be < 2 x IULN). For participants 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)
  • Participants must have a serum creatinine =< the IULN OR measured 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 sub-study randomization
  • Participants must have Zubrod performance status 0-1 documented within 28 days prior to sub-study randomization
  • Participants must provide pre-study history and physical exam within 28 days prior to sub-study randomization
  • Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to sub-study randomization
  • Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment must have an undetectable HCV viral load within 28 days prior to sub-study randomization
  • 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 sub-study randomization
  • Participants must be able to swallow capsules
  • Participants must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)
  • Participants must also be offered participation in banking and in the correlative studies for collection and future use of specimens
  • Participants 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)
  • Participants 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

Who cannot join

  • Participants 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 sub-study randomization, AND (2) participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to sub-study randomization
  • Participants must not have received any prior systemic therapy (systemic chemotherapy, tyrosine kinase inhibitor [TKI], immunotherapy or investigational drug) within 14 days prior to sub-study randomization
  • Participants 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
  • Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
  • Participants must not have had a major surgery within 14 days prior to sub-study randomization. Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator
  • 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, or serious uncontrolled cardiac arrhythmia
  • Participants must not be pregnant or nursing. 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

Trial locations and contacts

265 sites in 1 country.

265 sites in 1 country

United States265 sites

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • UPMC Altoona

    Altoona, Pennsylvania, 16601

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • AdventHealth Infusion Center Asheville

    Asheville, North Carolina, 28803

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

  • Sutter Auburn Faith Hospital

    Auburn, California, 95602

  • Kaiser Permanente-Baldwin Park

    Baldwin Park, California, 91706

  • Advocate Good Shepherd Hospital

    Barrington, Illinois, 60010

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • UPMC-Heritage Valley Health System Beaver

    Beaver, Pennsylvania, 15009

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • Saint Joseph Mercy Brighton

    Brighton, Michigan, 48114

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • UPMC Hillman Cancer Center at Butler Health System

    Butler, Pennsylvania, 16001

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • UPMC Camp Hill

    Camp Hill, Pennsylvania, 17011

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Saint Joseph Mercy Canton

    Canton, Michigan, 48188

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Carlisle Regional Cancer Center

    Carlisle, Pennsylvania, 17015

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • WellSpan Medical Oncology and Hematology

    Chambersburg, Pennsylvania, 17201

  • Ralph H Johnson VA Medical Center

    Charleston, South Carolina, 29401

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Saint Joseph Mercy Chelsea

    Chelsea, Michigan, 48118

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

  • Northwestern University

    Chicago, Illinois, 60611

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • AdventHealth Infusion Center Haywood

    Clyde, North Carolina, 28721

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Baptist Memorial Hospital and Cancer Center-Collierville

    Collierville, Tennessee, 38017

  • Baptist Memorial Hospital and Cancer Center-Golden Triangle

    Columbus, Mississippi, 39705

  • New Hampshire Oncology Hematology PA-Concord

    Concord, New Hampshire, 03301

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • UPMC Hillman Cancer Center - Passavant - Cranberry

    Cranberry Township, Pennsylvania, 16066

  • AMG Crystal Lake - Oncology

    Crystal Lake, Illinois, 60014

  • UPMC Western Maryland

    Cumberland, Maryland, 21502

  • Carle on Vermilion

    Danville, Illinois, 61832

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Ascension Saint John Hospital

    Detroit, Michigan, 48236

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Great Lakes Cancer Management Specialists-Doctors Park

    East China Township, Michigan, 48054

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Advocate Sherman Hospital

    Elgin, Illinois, 60123

  • Ephrata Cancer Center

    Ephrata, Pennsylvania, 17522

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Essentia Health Cancer Center-South University Clinic

    Fargo, North Dakota, 58103

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • UPMC Cancer Center at UPMC Horizon

    Farrell, Pennsylvania, 16121

  • Genesee Cancer and Blood Disease Treatment Center

    Flint, Michigan, 48503

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Kaiser Permanente-Fontana

    Fontana, California, 92335

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Palo Alto Medical Foundation-Fremont

    Fremont, California, 94538

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • 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

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • UPMC Cancer Centers - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

  • Oncology Hematology Associates

    Greenville, Pennsylvania, 16125

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Baptist Cancer Center-Grenada

    Grenada, Mississippi, 38901

  • Academic Hematology Oncology Specialists

    Grosse Pointe Woods, Michigan, 48236

  • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

    Grosse Pointe Woods, Michigan, 48236

  • Kaiser Permanente - Harbor City

    Harbor City, California, 90710

  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    Harrisburg, Pennsylvania, 17109

  • HaysMed University of Kansas Health System

    Hays, Kansas, 67601

  • Advocate South Suburban Hospital

    Hazel Crest, Illinois, 60429

  • AdventHealth Hendersonville

    Hendersonville, North Carolina, 28792

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746

  • IRMC Cancer Center

    Indiana, Pennsylvania, 15701

  • Kaiser Permanente-Irvine

    Irvine, California, 92618

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

    Johnstown, Pennsylvania, 15901

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

    Jonesboro, Arkansas, 72401

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • 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

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • OptumCare Cancer Care at Charleston

    Las Vegas, Nevada, 89102

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada, 89148

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • 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

  • AMG Libertyville - Oncology

    Libertyville, Illinois, 60048

  • Condell Memorial Hospital

    Libertyville, Illinois, 60048

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Kaiser Permanente West Los Angeles

    Los Angeles, California, 90034

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Great Lakes Cancer Management Specialists-Macomb Medical Campus

    Macomb, Michigan, 48044

  • Solinsky Center for Cancer Care

    Manchester, New Hampshire, 03103

  • Cleveland Clinic Cancer Center Mansfield

    Mansfield, Ohio, 44906

  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • UPMC Cancer Center at UPMC McKeesport

    McKeesport, Pennsylvania, 15132

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

    Mechanicsburg, Pennsylvania, 17050

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • Minneapolis VA Medical Center

    Minneapolis, Minnesota, 55417

  • Community Medical Hospital

    Missoula, Montana, 59804

  • UPMC Cancer Center - Monroeville

    Monroeville, Pennsylvania, 15146

  • UPMC Hillman Cancer Center - Monroeville

    Monroeville, Pennsylvania, 15146

  • UPMC Hillman Cancer Center in Coraopolis

    Moon Township, Pennsylvania, 15108

  • Virtua Samson Cancer Center

    Moorestown, New Jersey, 08057

  • Trinity Health Muskegon Hospital

    Muskegon, Michigan, 49444

  • Arnold Palmer Cancer Center Medical Oncology Norwin

    N. Huntingdon, Pennsylvania, 15642

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83686

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

  • UPMC Cancer Center-Natrona Heights

    Natrona Heights, Pennsylvania, 15065

  • Baptist Memorial Hospital and Cancer Center-Union County

    New Albany, Mississippi, 38652

  • UPMC Hillman Cancer Center - New Castle

    New Castle, Pennsylvania, 16105

  • University of Kansas Cancer Center at North Kansas City Hospital

    North Kansas City, Missouri, 64116

  • Cancer and Hematology Centers of Western Michigan - Norton Shores

    Norton Shores, Michigan, 49444

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453-2699

  • Olathe Health Cancer Center

    Olathe, Kansas, 66061

  • Kaiser Permanente-Ontario

    Ontario, California, 91761

  • Saint Alphonsus Medical Center-Ontario

    Ontario, Oregon, 97914

  • 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

  • Baptist Memorial Hospital and Cancer Center-Oxford

    Oxford, Mississippi, 38655

  • Palo Alto Medical Foundation Health Care

    Palo Alto, California, 94301

  • Kaiser Permanente - Panorama City

    Panorama City, California, 91402

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • UPMC-Saint Margaret

    Pittsburgh, Pennsylvania, 15215

  • UPMC-Mercy Hospital

    Pittsburgh, Pennsylvania, 15219

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232

  • UPMC-Passavant Hospital

    Pittsburgh, Pennsylvania, 15237

  • UPMC-Saint Clair Hospital Cancer Center

    Pittsburgh, Pennsylvania, 15243

  • Kaiser Permanente Northwest

    Portland, Oregon, 97227

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Aurora Cancer Care-Racine

    Racine, Wisconsin, 53406

  • Spectrum Health Reed City Hospital

    Reed City, Michigan, 49677

  • Kaiser Permanente-Riverside

    Riverside, California, 92505

  • University of Rochester

    Rochester, New York, 14642

  • Sutter Roseville Medical Center

    Roseville, California, 95661

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

  • 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

  • Veterans Affairs Medical Center - San Francisco

    San Francisco, California, 94121

  • Kaiser Permanente-San Marcos

    San Marcos, California, 92078

  • Kootenai Cancer Clinic

    Sandpoint, Idaho, 83864

  • Essentia Health Sandstone

    Sandstone, Minnesota, 55072

  • North Coast Cancer Care

    Sandusky, Ohio, 44870

  • UPMC Cancer Center at UPMC Northwest

    Seneca, Pennsylvania, 16346

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Baptist Memorial Hospital and Cancer Center-Desoto

    Southhaven, Mississippi, 38671

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Saint Helena Hospital

    St. Helena, California, 94574

  • Bhadresh Nayak MD PC-Sterling Heights

    Sterling Heights, Michigan, 48312

  • Trinity's Tony Teramana Cancer Center

    Steubenville, Ohio, 43952

  • Cleveland Clinic Cancer Center Strongsville

    Strongsville, Ohio, 44136

  • 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

  • University of Kansas Health System Saint Francis Campus

    Topeka, Kansas, 66606

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Upper Valley Medical Center

    Troy, Ohio, 45373

  • Saint Luke's Cancer Institute - Twin Falls

    Twin Falls, Idaho, 83301

  • Vince Lombardi Cancer Clinic-Two Rivers

    Two Rivers, Wisconsin, 54241

  • UPMC Cancer Center-Uniontown

    Uniontown, Pennsylvania, 15401

  • UPMC Uniontown Hospital Radiation Oncology

    Uniontown, Pennsylvania, 15401

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Sutter Solano Medical Center/Cancer Center

    Vallejo, California, 94589

  • Essentia Health Virginia Clinic

    Virginia, Minnesota, 55792

  • Virtua Voorhees

    Voorhees Township, New Jersey, 08043

  • Great Lakes Cancer Management Specialists-Macomb Professional Building

    Warren, Michigan, 48093

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

  • South Pointe Hospital

    Warrensville Heights, Ohio, 44122

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

  • UPMC Washington Hospital Radiation Oncology

    Washington, Pennsylvania, 15301

  • Aurora Cancer Care-Milwaukee West

    Wauwatosa, Wisconsin, 53226

  • AdventHealth Infusion Center Weaverville

    Weaverville, North Carolina, 28787

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

  • UPMC West Mifflin-Cancer Center Jefferson

    West Mifflin, Pennsylvania, 15122

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205

  • Presbyterian Intercommunity Hospital

    Whittier, California, 90602

  • Kaiser Permanente-Woodland Hills

    Woodland Hills, California, 91367

  • Cleveland Clinic Wooster Family Health and Surgery Center

    Wooster, Ohio, 44691

  • Metro Health Hospital

    Wyoming, Michigan, 49519

  • WellSpan Health-York Cancer Center

    York, Pennsylvania, 17403

  • WellSpan Health-York Hospital

    York, Pennsylvania, 17403

  • UPMC Memorial

    York, Pennsylvania, 17408

  • Huron Gastroenterology PC

    Ypsilanti, Michigan, 48106

  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: A Randomized Phase II Study of Carboplatin and Pemetrexed w/ or w/o Selpercatinib in Participants With Non-Squamous RET Fusion-Positive Stage IV Non-Small Cell Lung Cancer and Progression of Disease on Prior RET Directed Therapy (Lung-MAP Sub-Study)

This phase II Lung-MAP treatment trial tests whether carboplatin and pemetrexed with or without selpercatinib works to shrink tumors in patients with RET fusion-positive non-small cell lung cancer that is stage IV or has not responded to previous RET directed therapy. Chemotherapy drugs, such as carboplatin and pemetrexed, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Selpercatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving selpercatinib in combination with carboplatin and pemetrexed may help lower the chance of the cancer growing and spreading.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To compare investigator-assessed progression-free survival (IA-PFS) in participants with RET fusion-positive non-small cell lung cancer (NSCLC) with acquired selective RET inhibitor resistance randomized to carboplatin and pemetrexed with or without selpercatinib.

SECONDARY OBJECTIVES:

  1. To evaluate if the combination of selpercatinib combined with carboplatin and pemetrexed during the first cycle of treatment has an acceptable toxicity rate.

II. To evaluate the frequency and severity of toxicities within the arms. III. To compare the investigator-assessed objective response rate (ORR) (complete or partial confirmed response) between the arms.

IV. To compare overall survival (OS) between the arms. V. To evaluate duration of investigator-assessed response among responders within each treatment arm.

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 participants with refractory non-small cell lung cancer (NSCLC).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive carboplatin intravenously (IV) over 30 minutes and pemetrexed IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also selpercatinib orally (PO) twice daily (BID) in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive carboplatin IV over 30 minutes and pemetrexed IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients who had disease progression are followed up every 6 months for 2 years and then at 3 years. Patients who did not have disease progression are followed up every 12 weeks until disease progression.

Being tested
Carboplatin, Pemetrexed, 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.

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • PemetrexedDrug

    Also called MTA, Multitargeted Antifolate, Pemfexy

    Given IV

  • SelpercatinibDrug

    Also called LOXO-292, RET Kinase Inhibitor LOXO-292, Retevmo, WHO 10967

    Given PO

Study groups in NCT05364645
Study groupRoleWhat they receive
Arm A (carboplatin, pemetrexed, selpercatinib)ExperimentalPatients receive carboplatin IV over 30 minutes and pemetrexed IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also selpercatinib PO BID in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Carboplatin; Drug: Pemetrexed; Drug: Selpercatinib
Arm B (carboplatin, pemetrexed)Active comparatorPatients receive carboplatin IV over 30 minutes and pemetrexed IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Carboplatin; Drug: Pemetrexed

What is being measured

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

  1. Investigator-assessed progression-free survival (PFS)

    Will be compared between the arms using a 1-sided log-rank test at the 0.10 level upon the observation of 55 PFS events or at a maximum follow-up duration (from closure of accrual of 15 months). Will be estimated using the method of Kaplan-Meier. Confidence intervals about median event times will be estimated using the Brookmeyer-Crowley method. For point estimates at landmark times, the associated 95% confidence interval (CI) will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Hazard ratios for these outcomes will be estimated using a Cox Proportional Hazards regression.

    Measured: From date of sub-study randomization 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

Secondary outcomes (5)

  1. Incidence of grade 3 or higher non hematologic toxicity and grade 4 or higher hematologic toxicity

    Measured: During first cycle (1 cycle = 21 days)

  2. Frequency and severity of adverse events

    Measured: Up to 3 years

  3. Investigator-assessed objective response rate

    Measured: Up to 3 years

  4. Overall survival

    Will be estimated using the method of Kaplan-Meier. Confidence intervals about median event times will be estimated using the Brookmeyer-Crowley method. For point estimates at landmark times, the associated 95% CI will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Hazard ratios for these outcomes will be estimated using a Cox Proportional Hazards regression.

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

  5. Duration of investigator-assessed response

    Will be estimated using the method of Kaplan-Meier. Confidence intervals about median event times will be estimated using the Brookmeyer-Crowley method. For point estimates at landmark times, the associated 95% CI will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Hazard ratios for these outcomes will be estimated using a Cox Proportional Hazards regression.

    Measured: From date of first documentation of response (complete response [CR] or partial response [PR]) to date of first documentation of progression, or death due to any cause among participants who achieve a response (CR or PR), assessed up to 3 years

Timeline

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

  1. First posted6 May 2022
  2. Study start25 Jul 2022 (estimated)
  3. Primary completion27 Jun 2023 (estimated)
  4. Study completion1 May 2029 (estimated)

Why it stopped: lack of accrual

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05364645
Sponsor's protocol ID
S1900F
Other IDs
NCI-2022-02517, S1900F, S1900F, U10CA180888
Status last verified
Jul 2024
First submitted
3 May 2022
Last updated
9 Jul 2024
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 Carboplatin, Pemetrexed and Selpercatinib in people with Lung Non-Small Cell Carcinoma and Recurrent Lung Non-Small Cell Carcinoma, run by SWOG Cancer Research Network at 265 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 7 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: withdrawn, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 265 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Investigator-assessed progression-free survival (PFS) (time frame: From date of sub-study randomization 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). 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 NCT05364645.

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 Jul 2024.

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