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

February 28, 2023 updated by: Southwest Oncology Group

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. 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:

I. 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:

I. 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.

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Arkansas
  - Jonesboro, Arkansas, United States, 72401
    - Recruiting
    - NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
    - Principal Investigator:
      
      Osarenren Ogbeide
  - Little Rock, Arkansas, United States, 72205
    - Recruiting
    - University of Arkansas for Medical Sciences
    - Principal Investigator:
      
      Konstantinos Arnaoutakis
- California
  - Anaheim, California, United States, 92806
    - Recruiting
    - Kaiser Permanente-Anaheim
  - Auburn, California, United States, 95602
    - Recruiting
    - Sutter Auburn Faith Hospital
  - Baldwin Park, California, United States, 91706
    - Recruiting
    - Kaiser Permanente-Baldwin Park
  - Bellflower, California, United States, 90706
    - Recruiting
    - Kaiser Permanente-Bellflower
  - Berkeley, California, United States, 94704
    - Recruiting
    - Alta Bates Summit Medical Center-Herrick Campus
  - Fontana, California, United States, 92335
    - Recruiting
    - Kaiser Permanente-Fontana
  - Fremont, California, United States, 94538
    - Recruiting
    - Palo Alto Medical Foundation-Fremont
  - Harbor City, California, United States, 90710
    - Recruiting
    - Kaiser Permanente - Harbor City
  - Irvine, California, United States, 92618
    - Recruiting
    - Kaiser Permanente-Irvine
  - Loma Linda, California, United States, 92354
    - Recruiting
    - Loma Linda University Medical Center
  - Los Angeles, California, United States, 90027
    - Recruiting
    - Kaiser Permanente Los Angeles Medical Center
  - Los Angeles, California, United States, 90034
    - Recruiting
    - Kaiser Permanente West Los Angeles
  - Ontario, California, United States, 91761
    - Recruiting
    - Kaiser Permanente-Ontario
  - Palo Alto, California, United States, 94301
    - Recruiting
    - Palo Alto Medical Foundation Health Care
  - Panorama City, California, United States, 91402
    - Recruiting
    - Kaiser Permanente - Panorama City
  - Riverside, California, United States, 92505
    - Recruiting
    - Kaiser Permanente-Riverside
  - Roseville, California, United States, 95661
    - Recruiting
    - Sutter Roseville Medical Center
  - Sacramento, California, United States, 95817
    - Recruiting
    - University of California Davis Comprehensive Cancer Center
  - Sacramento, California, United States, 95816
    - Recruiting
    - Sutter Medical Center Sacramento
  - Saint Helena, California, United States, 94574
    - Recruiting
    - Saint Helena Hospital
  - San Diego, California, United States, 92120
    - Recruiting
    - Kaiser Permanente-San Diego Zion
  - San Francisco, California, United States, 94115
    - Recruiting
    - California Pacific Medical Center-Pacific Campus
  - San Francisco, California, United States, 94121
    - Recruiting
    - Veterans Affairs Medical Center - San Francisco
  - San Marcos, California, United States, 92078
    - Recruiting
    - Kaiser Permanente-San Marcos
  - Sunnyvale, California, United States, 94086
    - Recruiting
    - Palo Alto Medical Foundation-Sunnyvale
  - Vallejo, California, United States, 94589
    - Recruiting
    - Sutter Solano Medical Center/Cancer Center
  - Whittier, California, United States, 90602
    - Recruiting
    - Presbyterian Intercommunity Hospital
  - Woodland Hills, California, United States, 91367
    - Recruiting
    - Kaiser Permanente-Woodland Hills
- Florida
  - Miami Beach, Florida, United States, 33140
    - Recruiting
    - Mount Sinai Medical Center
  - Tampa, Florida, United States, 33612
    - Recruiting
    - Moffitt Cancer Center
- Idaho
  - Boise, Idaho, United States, 83712
    - Recruiting
    - Saint Luke's Cancer Institute - Boise
  - Boise, Idaho, United States, 83706
    - Recruiting
    - Saint Alphonsus Cancer Care Center-Boise
  - Caldwell, Idaho, United States, 83605
    - Recruiting
    - Saint Alphonsus Cancer Care Center-Caldwell
  - Coeur d'Alene, Idaho, United States, 83814
    - Recruiting
    - Kootenai Health - Coeur d'Alene
  - Fruitland, Idaho, United States, 83619
    - Recruiting
    - Saint Luke's Cancer Institute - Fruitland
  - Meridian, Idaho, United States, 83642
    - Recruiting
    - Saint Luke's Cancer Institute - Meridian
  - Nampa, Idaho, United States, 83686
    - Recruiting
    - Saint Luke's Cancer Institute - Nampa
  - Nampa, Idaho, United States, 83687
    - Recruiting
    - Saint Alphonsus Cancer Care Center-Nampa
  - Post Falls, Idaho, United States, 83854
    - Recruiting
    - Kootenai Clinic Cancer Services - Post Falls
  - Sandpoint, Idaho, United States, 83864
    - Recruiting
    - Kootenai Cancer Clinic
  - Twin Falls, Idaho, United States, 83301
    - Recruiting
    - Saint Luke's Cancer Institute - Twin Falls
- Illinois
  - Barrington, Illinois, United States, 60010
    - Recruiting
    - Advocate Good Shepherd Hospital
  - Bloomington, Illinois, United States, 61704
    - Recruiting
    - Illinois CancerCare-Bloomington
  - Canton, Illinois, United States, 61520
    - Recruiting
    - Illinois CancerCare-Canton
  - Carthage, Illinois, United States, 62321
    - Recruiting
    - Illinois CancerCare-Carthage
  - Centralia, Illinois, United States, 62801
    - Recruiting
    - Centralia Oncology Clinic
  - Chicago, Illinois, United States, 60611
    - Recruiting
    - Northwestern University
  - Chicago, Illinois, United States, 60657
    - Recruiting
    - Advocate Illinois Masonic Medical Center
  - Crystal Lake, Illinois, United States, 60014
    - Recruiting
    - AMG Crystal Lake - Oncology
  - Danville, Illinois, United States, 61832
    - Recruiting
    - Carle on Vermilion
  - DeKalb, Illinois, United States, 60115
    - Recruiting
    - Northwestern Medicine Cancer Center Kishwaukee
  - Decatur, Illinois, United States, 62526
    - Recruiting
    - Cancer Care Specialists of Illinois - Decatur
  - Decatur, Illinois, United States, 62526
    - Recruiting
    - Decatur Memorial Hospital
  - Dixon, Illinois, United States, 61021
    - Recruiting
    - Illinois CancerCare-Dixon
  - Downers Grove, Illinois, United States, 60515
    - Recruiting
    - Advocate Good Samaritan Hospital
  - Effingham, Illinois, United States, 62401
    - Recruiting
    - Carle Physician Group-Effingham
  - Effingham, Illinois, United States, 62401
    - Recruiting
    - Crossroads Cancer Center
  - Elgin, Illinois, United States, 60123
    - Recruiting
    - Advocate Sherman Hospital
  - Eureka, Illinois, United States, 61530
    - Recruiting
    - Illinois CancerCare-Eureka
  - Galesburg, Illinois, United States, 61401
    - Recruiting
    - Illinois CancerCare-Galesburg
  - Geneva, Illinois, United States, 60134
    - Recruiting
    - Northwestern Medicine Cancer Center Delnor
  - Hazel Crest, Illinois, United States, 60429
    - Recruiting
    - Advocate South Suburban Hospital
  - Kewanee, Illinois, United States, 61443
    - Recruiting
    - Illinois CancerCare-Kewanee Clinic
  - Lake Forest, Illinois, United States, 60045
    - Recruiting
    - Northwestern Medicine Lake Forest Hospital
  - Libertyville, Illinois, United States, 60048
    - Recruiting
    - AMG Libertyville - Oncology
  - Libertyville, Illinois, United States, 60048
    - Recruiting
    - Condell Memorial Hospital
  - Macomb, Illinois, United States, 61455
    - Recruiting
    - Illinois CancerCare-Macomb
  - Mattoon, Illinois, United States, 61938
    - Recruiting
    - Carle Physician Group-Mattoon/Charleston
  - O'Fallon, Illinois, United States, 62269
    - Recruiting
    - Cancer Care Center of O'Fallon
  - Oak Lawn, Illinois, United States, 60453-2699
    - Recruiting
    - Advocate Christ Medical Center
  - Ottawa, Illinois, United States, 61350
    - Recruiting
    - Illinois CancerCare-Ottawa Clinic
  - Park Ridge, Illinois, United States, 60068
    - Recruiting
    - Advocate Lutheran General Hospital
  - Pekin, Illinois, United States, 61554
    - Recruiting
    - Illinois CancerCare-Pekin
  - Peoria, Illinois, United States, 61615
    - Recruiting
    - Illinois CancerCare-Peoria
  - Peru, Illinois, United States, 61354
    - Recruiting
    - Illinois CancerCare-Peru
  - Princeton, Illinois, United States, 61356
    - Recruiting
    - Illinois CancerCare-Princeton
  - Springfield, Illinois, United States, 62702
    - Recruiting
    - Southern Illinois University School of Medicine
  - Springfield, Illinois, United States, 62702
    - Recruiting
    - Springfield Clinic
  - Springfield, Illinois, United States, 62781
    - Recruiting
    - Memorial Medical Center
  - Urbana, Illinois, United States, 61801
    - Recruiting
    - Carle Cancer Center
  - Warrenville, Illinois, United States, 60555
    - Recruiting
    - Northwestern Medicine Cancer Center Warrenville
- Iowa
  - Des Moines, Iowa, United States, 50314
    - Recruiting
    - Mercy Medical Center - Des Moines
- Kansas
  - Hays, Kansas, United States, 67601
    - Recruiting
    - HaysMed University of Kansas Health System
  - Kansas City, Kansas, United States, 66160
    - Recruiting
    - University of Kansas Cancer Center
  - Lawrence, Kansas, United States, 66044
    - Recruiting
    - Lawrence Memorial Hospital
  - Olathe, Kansas, United States, 66061
    - Recruiting
    - Olathe Health Cancer Center
  - Overland Park, Kansas, United States, 66210
    - Recruiting
    - University of Kansas Cancer Center-Overland Park
  - Salina, Kansas, United States, 67401
    - Recruiting
    - Salina Regional Health Center
  - Topeka, Kansas, United States, 66606
    - Recruiting
    - University of Kansas Health System Saint Francis Campus
  - Westwood, Kansas, United States, 66205
    - Recruiting
    - University of Kansas Hospital-Westwood Cancer Center
- Kentucky
  - Lexington, Kentucky, United States, 40536
    - Recruiting
    - University of Kentucky/Markey Cancer Center
    - Contact:
      
      Susanne M. Arnold
      
      Phone Number: 859-323-8043
      
      Email: smarno0@uky.edu
- Maryland
  - Cumberland, Maryland, United States, 21502
    - Recruiting
    - UPMC Western Maryland
- Michigan
  - Ann Arbor, Michigan, United States, 48106
    - Recruiting
    - Saint Joseph Mercy Hospital
  - Battle Creek, Michigan, United States, 49017
    - Recruiting
    - Bronson Battle Creek
  - Brighton, Michigan, United States, 48114
    - Recruiting
    - Saint Joseph Mercy Brighton
  - Brighton, Michigan, United States, 48114
    - Recruiting
    - Trinity Health IHA Medical Group Hematology Oncology - Brighton
  - Canton, Michigan, United States, 48188
    - Recruiting
    - Saint Joseph Mercy Canton
  - Canton, Michigan, United States, 48188
    - Recruiting
    - Trinity Health IHA Medical Group Hematology Oncology - Canton
  - Chelsea, Michigan, United States, 48118
    - Recruiting
    - Saint Joseph Mercy Chelsea
  - Chelsea, Michigan, United States, 48118
    - Recruiting
    - Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
  - Detroit, Michigan, United States, 48236
    - Recruiting
    - Ascension Saint John Hospital
  - East China Township, Michigan, United States, 48054
    - Recruiting
    - Great Lakes Cancer Management Specialists-Doctors Park
  - Flint, Michigan, United States, 48503
    - Recruiting
    - Genesee Cancer and Blood Disease Treatment Center
  - Flint, Michigan, United States, 48503
    - Recruiting
    - Genesee Hematology Oncology PC
  - Flint, Michigan, United States, 48503
    - Recruiting
    - Genesys Hurley Cancer Institute
  - Flint, Michigan, United States, 48503
    - Recruiting
    - Hurley Medical Center
  - Grand Rapids, Michigan, United States, 49503
    - Recruiting
    - Spectrum Health at Butterworth Campus
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Recruiting
    - Academic Hematology Oncology Specialists
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Recruiting
    - Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
  - Kalamazoo, Michigan, United States, 49007
    - Recruiting
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49007
    - Recruiting
    - West Michigan Cancer Center
  - Lansing, Michigan, United States, 48912
    - Recruiting
    - Sparrow Hospital
  - Livonia, Michigan, United States, 48154
    - Recruiting
    - Trinity Health Saint Mary Mercy Livonia Hospital
  - Macomb, Michigan, United States, 48044
    - Recruiting
    - Great Lakes Cancer Management Specialists-Macomb Medical Campus
  - Muskegon, Michigan, United States, 49444
    - Recruiting
    - Trinity Health Muskegon Hospital
  - Norton Shores, Michigan, United States, 49444
    - Recruiting
    - Cancer and Hematology Centers of Western Michigan - Norton Shores
  - Reed City, Michigan, United States, 49677
    - Recruiting
    - Spectrum Health Reed City Hospital
  - Saint Joseph, Michigan, United States, 49085
    - Recruiting
    - Marie Yeager Cancer Center
  - Sterling Heights, Michigan, United States, 48312
    - Recruiting
    - Bhadresh Nayak MD PC-Sterling Heights
  - Traverse City, Michigan, United States, 49684
    - Recruiting
    - Munson Medical Center
  - Warren, Michigan, United States, 48093
    - Recruiting
    - Great Lakes Cancer Management Specialists-Macomb Professional Building
  - Warren, Michigan, United States, 48093
    - Recruiting
    - Saint John Macomb-Oakland Hospital
  - Wyoming, Michigan, United States, 49519
    - Recruiting
    - Metro Health Hospital
  - Ypsilanti, Michigan, United States, 48106
    - Recruiting
    - Huron Gastroenterology PC
  - Ypsilanti, Michigan, United States, 48197
    - Recruiting
    - Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
- Minnesota
  - Bemidji, Minnesota, United States, 56601
    - Recruiting
    - Sanford Joe Lueken Cancer Center
  - Brainerd, Minnesota, United States, 56401
    - Recruiting
    - Essentia Health Saint Joseph's Medical Center
  - Coon Rapids, Minnesota, United States, 55433
    - Recruiting
    - Mercy Hospital
  - Deer River, Minnesota, United States, 56636
    - Recruiting
    - Essentia Health - Deer River Clinic
  - Duluth, Minnesota, United States, 55805
    - Recruiting
    - Essentia Health Cancer Center
  - Edina, Minnesota, United States, 55435
    - Recruiting
    - Fairview Southdale Hospital
  - Hibbing, Minnesota, United States, 55746
    - Recruiting
    - Essentia Health Hibbing Clinic
  - Minneapolis, Minnesota, United States, 55417
    - Recruiting
    - Minneapolis VA Medical Center
  - Saint Louis Park, Minnesota, United States, 55416
    - Recruiting
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Paul, Minnesota, United States, 55101
    - Recruiting
    - Regions Hospital
  - Saint Paul, Minnesota, United States, 55102
    - Recruiting
    - United Hospital
  - Sandstone, Minnesota, United States, 55072
    - Recruiting
    - Essentia Health Sandstone
  - Virginia, Minnesota, United States, 55792
    - Recruiting
    - Essentia Health Virginia Clinic
- Mississippi
  - Columbus, Mississippi, United States, 39705
    - Recruiting
    - Baptist Memorial Hospital and Cancer Center-Golden Triangle
    - Principal Investigator:
      
      Osarenren Ogbeide
  - Grenada, Mississippi, United States, 38901
    - Recruiting
    - Baptist Cancer Center-Grenada
    - Principal Investigator:
      
      Osarenren Ogbeide
  - New Albany, Mississippi, United States, 38652
    - Recruiting
    - Baptist Memorial Hospital and Cancer Center-Union County
    - Principal Investigator:
      
      Osarenren Ogbeide
  - Oxford, Mississippi, United States, 38655
    - Recruiting
    - Baptist Memorial Hospital and Cancer Center-Oxford
    - Principal Investigator:
      
      Osarenren Ogbeide
  - Southhaven, Mississippi, United States, 38671
    - Recruiting
    - Baptist Memorial Hospital and Cancer Center-Desoto
    - Principal Investigator:
      
      Osarenren Ogbeide
- Missouri
  - Cape Girardeau, Missouri, United States, 63703
    - Recruiting
    - Saint Francis Medical Center
  - Farmington, Missouri, United States, 63640
    - Recruiting
    - Parkland Health Center - Farmington
  - Kansas City, Missouri, United States, 64108
    - Recruiting
    - Truman Medical Centers
  - Kansas City, Missouri, United States, 64154
    - Recruiting
    - University of Kansas Cancer Center - North
  - Lee's Summit, Missouri, United States, 64064
    - Recruiting
    - University of Kansas Cancer Center - Lee's Summit
  - North Kansas City, Missouri, United States, 64116
    - Recruiting
    - University of Kansas Cancer Center at North Kansas City Hospital
  - Saint Louis, Missouri, United States, 63131
    - Recruiting
    - Missouri Baptist Medical Center
  - Sainte Genevieve, Missouri, United States, 63670
    - Recruiting
    - Sainte Genevieve County Memorial Hospital
  - Sullivan, Missouri, United States, 63080
    - Recruiting
    - Missouri Baptist Sullivan Hospital
  - Sunset Hills, Missouri, United States, 63127
    - Recruiting
    - Missouri Baptist Outpatient Center-Sunset Hills
- Montana
  - Anaconda, Montana, United States, 59711
    - Recruiting
    - Community Hospital of Anaconda
  - Billings, Montana, United States, 59101
    - Recruiting
    - Billings Clinic Cancer Center
  - Bozeman, Montana, United States, 59715
    - Recruiting
    - Bozeman Deaconess Hospital
  - Great Falls, Montana, United States, 59405
    - Recruiting
    - Benefis Healthcare- Sletten Cancer Institute
  - Kalispell, Montana, United States, 59901
    - Recruiting
    - Kalispell Regional Medical Center
  - Missoula, Montana, United States, 59804
    - Recruiting
    - Community Medical Hospital
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - Recruiting
    - OptumCare Cancer Care at Charleston
  - Las Vegas, Nevada, United States, 89148
    - Recruiting
    - OptumCare Cancer Care at Fort Apache
- New Hampshire
  - Concord, New Hampshire, United States, 03301
    - Recruiting
    - New Hampshire Oncology Hematology PA-Concord
  - Manchester, New Hampshire, United States, 03103
    - Recruiting
    - Solinsky Center for Cancer Care
- New Jersey
  - Moorestown, New Jersey, United States, 08057
    - Recruiting
    - Virtua Samson Cancer Center
  - Voorhees, New Jersey, United States, 08043
    - Recruiting
    - Virtua Voorhees
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - Recruiting
    - University of New Mexico Cancer Center
- New York
  - Rochester, New York, United States, 14642
    - Recruiting
    - University of Rochester
- North Carolina
  - Asheville, North Carolina, United States, 28803
    - Recruiting
    - AdventHealth Infusion Center Asheville
  - Clyde, North Carolina, United States, 28721
    - Recruiting
    - AdventHealth Infusion Center Haywood
  - Hendersonville, North Carolina, United States, 28792
    - Recruiting
    - AdventHealth Hendersonville
  - Weaverville, North Carolina, United States, 28787
    - Recruiting
    - AdventHealth Infusion Center Weaverville
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Recruiting
    - Sanford Bismarck Medical Center
  - Fargo, North Dakota, United States, 58122
    - Recruiting
    - Sanford Broadway Medical Center
  - Fargo, North Dakota, United States, 58103
    - Recruiting
    - Essentia Health Cancer Center-South University Clinic
  - Fargo, North Dakota, United States, 58122
    - Recruiting
    - Sanford Roger Maris Cancer Center
- Ohio
  - Canton, Ohio, United States, 44710
    - Recruiting
    - Aultman Health Foundation
  - Centerville, Ohio, United States, 45459
    - Recruiting
    - Miami Valley Hospital South
  - Cleveland, Ohio, United States, 44195
    - Active, not recruiting
    - Cleveland Clinic Foundation
  - Cleveland, Ohio, United States, 44111
    - Active, not recruiting
    - Cleveland Clinic Cancer Center/Fairview Hospital
  - Dayton, Ohio, United States, 45409
    - Recruiting
    - Miami Valley Hospital
  - Dayton, Ohio, United States, 45415
    - Recruiting
    - Miami Valley Hospital North
  - Franklin, Ohio, United States, 45005-1066
    - Recruiting
    - Atrium Medical Center-Middletown Regional Hospital
  - Mansfield, Ohio, United States, 44906
    - Active, not recruiting
    - Cleveland Clinic Cancer Center Mansfield
  - Mayfield Heights, Ohio, United States, 44124
    - Active, not recruiting
    - Hillcrest Hospital Cancer Center
  - Sandusky, Ohio, United States, 44870
    - Active, not recruiting
    - North Coast Cancer Care
  - Steubenville, Ohio, United States, 43952
    - Recruiting
    - Trinity's Tony Teramana Cancer Center
  - Strongsville, Ohio, United States, 44136
    - Active, not recruiting
    - Cleveland Clinic Cancer Center Strongsville
  - Sylvania, Ohio, United States, 43560
    - Recruiting
    - ProMedica Flower Hospital
    - Principal Investigator:
      
      Ahmed G. Elsayed
  - Troy, Ohio, United States, 45373
    - Recruiting
    - Upper Valley Medical Center
  - Warrensville Heights, Ohio, United States, 44122
    - Active, not recruiting
    - South Pointe Hospital
  - Wooster, Ohio, United States, 44691
    - Active, not recruiting
    - Cleveland Clinic Wooster Family Health and Surgery Center
- Oregon
  - Ontario, Oregon, United States, 97914
    - Recruiting
    - Saint Alphonsus Medical Center-Ontario
  - Portland, Oregon, United States, 97227
    - Recruiting
    - Kaiser Permanente Northwest
- Pennsylvania
  - Altoona, Pennsylvania, United States, 16601
    - Recruiting
    - UPMC Altoona
  - Beaver, Pennsylvania, United States, 15009
    - Recruiting
    - UPMC-Heritage Valley Health System Beaver
  - Butler, Pennsylvania, United States, 16001
    - Recruiting
    - UPMC Hillman Cancer Center at Butler Health System
  - Camp Hill, Pennsylvania, United States, 17011
    - Recruiting
    - UPMC Camp Hill
  - Carlisle, Pennsylvania, United States, 17015
    - Recruiting
    - Carlisle Regional Cancer Center
  - Chambersburg, Pennsylvania, United States, 17201
    - Recruiting
    - WellSpan Medical Oncology and Hematology
    - Principal Investigator:
      
      Chanh T. Huynh
  - Cranberry Township, Pennsylvania, United States, 16066
    - Recruiting
    - UPMC Hillman Cancer Center - Passavant - Cranberry
  - Ephrata, Pennsylvania, United States, 17522
    - Recruiting
    - Ephrata Cancer Center
    - Principal Investigator:
      
      Chanh T. Huynh
  - Erie, Pennsylvania, United States, 16505
    - Recruiting
    - UPMC Hillman Cancer Center Erie
  - Farrell, Pennsylvania, United States, 16121
    - Recruiting
    - UPMC Cancer Center at UPMC Horizon
  - Gettysburg, Pennsylvania, United States, 17325
    - Recruiting
    - Adams Cancer Center
    - Principal Investigator:
      
      Chanh T. Huynh
  - Greensburg, Pennsylvania, United States, 15601
    - Recruiting
    - UPMC Cancer Centers - Arnold Palmer Pavilion
  - Greenville, Pennsylvania, United States, 16125
    - Recruiting
    - Oncology Hematology Associates
  - Harrisburg, Pennsylvania, United States, 17109
    - Recruiting
    - UPMC Pinnacle Cancer Center/Community Osteopathic Campus
  - Indiana, Pennsylvania, United States, 15701
    - Recruiting
    - IRMC Cancer Center
  - Johnstown, Pennsylvania, United States, 15901
    - Recruiting
    - UPMC-Johnstown/John P. Murtha Regional Cancer Center
  - Lebanon, Pennsylvania, United States, 17042
    - Recruiting
    - Sechler Family Cancer Center
    - Principal Investigator:
      
      Chanh T. Huynh
  - McKeesport, Pennsylvania, United States, 15132
    - Recruiting
    - UPMC Cancer Center at UPMC McKeesport
  - Mechanicsburg, Pennsylvania, United States, 17050
    - Recruiting
    - UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
  - Monroeville, Pennsylvania, United States, 15146
    - Recruiting
    - UPMC Hillman Cancer Center - Monroeville
  - Monroeville, Pennsylvania, United States, 15146
    - Recruiting
    - UPMC Cancer Center - Monroeville
  - Moon, Pennsylvania, United States, 15108
    - Recruiting
    - UPMC Hillman Cancer Center in Coraopolis
  - N. Huntingdon, Pennsylvania, United States, 15642
    - Recruiting
    - Arnold Palmer Cancer Center Medical Oncology Norwin
  - Natrona Heights, Pennsylvania, United States, 15065
    - Recruiting
    - UPMC Cancer Center-Natrona Heights
  - New Castle, Pennsylvania, United States, 16105
    - Recruiting
    - UPMC Hillman Cancer Center - New Castle
  - Pittsburgh, Pennsylvania, United States, 15232
    - Recruiting
    - University of Pittsburgh Cancer Institute (UPCI)
  - Pittsburgh, Pennsylvania, United States, 15215
    - Recruiting
    - UPMC-Saint Margaret
  - Pittsburgh, Pennsylvania, United States, 15219
    - Recruiting
    - UPMC-Mercy Hospital
  - Pittsburgh, Pennsylvania, United States, 15237
    - Recruiting
    - UPMC-Passavant Hospital
  - Pittsburgh, Pennsylvania, United States, 15243
    - Recruiting
    - UPMC-Saint Clair Hospital Cancer Center
  - Seneca, Pennsylvania, United States, 16346
    - Recruiting
    - UPMC Cancer Center at UPMC Northwest
  - Uniontown, Pennsylvania, United States, 15401
    - Recruiting
    - UPMC Cancer Center-Uniontown
  - Uniontown, Pennsylvania, United States, 15401
    - Recruiting
    - UPMC Uniontown Hospital Radiation Oncology
  - Washington, Pennsylvania, United States, 15301
    - Recruiting
    - UPMC Washington Hospital Radiation Oncology
  - West Mifflin, Pennsylvania, United States, 15122
    - Recruiting
    - UPMC West Mifflin-Cancer Center Jefferson
  - York, Pennsylvania, United States, 17403
    - Recruiting
    - WellSpan Health-York Cancer Center
    - Principal Investigator:
      
      Chanh T. Huynh
  - York, Pennsylvania, United States, 17403
    - Recruiting
    - WellSpan Health-York Hospital
    - Principal Investigator:
      
      Chanh T. Huynh
  - York, Pennsylvania, United States, 17408
    - Recruiting
    - UPMC Memorial
- South Carolina
  - Boiling Springs, South Carolina, United States, 29316
    - Recruiting
    - Prisma Health Cancer Institute - Spartanburg
  - Charleston, South Carolina, United States, 29425
    - Recruiting
    - Medical University of South Carolina
    - Principal Investigator:
      
      John M. Wrangle
  - Charleston, South Carolina, United States, 29401
    - Recruiting
    - Ralph H Johnson VA Medical Center
  - Easley, South Carolina, United States, 29640
    - Recruiting
    - Prisma Health Cancer Institute - Easley
  - Greenville, South Carolina, United States, 29605
    - Recruiting
    - Prisma Health Cancer Institute - Faris
  - Greenville, South Carolina, United States, 29605
    - Recruiting
    - Prisma Health Cancer Institute - Butternut
  - Greenville, South Carolina, United States, 29615
    - Recruiting
    - Prisma Health Cancer Institute - Eastside
  - Greenville, South Carolina, United States, 29605
    - Recruiting
    - Prisma Health Greenville Memorial Hospital
  - Greer, South Carolina, United States, 29650
    - Recruiting
    - Prisma Health Cancer Institute - Greer
  - Seneca, South Carolina, United States, 29672
    - Recruiting
    - Prisma Health Cancer Institute - Seneca
- South Dakota
  - Sioux Falls, South Dakota, United States, 57104
    - Recruiting
    - Sanford Cancer Center Oncology Clinic
  - Sioux Falls, South Dakota, United States, 57117-5134
    - Recruiting
    - Sanford USD Medical Center - Sioux Falls
- Tennessee
  - Collierville, Tennessee, United States, 38017
    - Recruiting
    - Baptist Memorial Hospital and Cancer Center-Collierville
    - Principal Investigator:
      
      Osarenren Ogbeide
  - Memphis, Tennessee, United States, 38120
    - Recruiting
    - Baptist Memorial Hospital and Cancer Center-Memphis
    - Principal Investigator:
      
      Osarenren Ogbeide
- Wisconsin
  - Ashland, Wisconsin, United States, 54806
    - Recruiting
    - Duluth Clinic Ashland
  - Burlington, Wisconsin, United States, 53105
    - Recruiting
    - Aurora Cancer Care-Southern Lakes VLCC
  - Germantown, Wisconsin, United States, 53022
    - Recruiting
    - Aurora Health Care Germantown Health Center
  - Grafton, Wisconsin, United States, 53024
    - Recruiting
    - Aurora Cancer Care-Grafton
  - Green Bay, Wisconsin, United States, 54311
    - Recruiting
    - Aurora BayCare Medical Center
  - Kenosha, Wisconsin, United States, 53142
    - Recruiting
    - Aurora Cancer Care-Kenosha South
  - La Crosse, Wisconsin, United States, 54601
    - Recruiting
    - Gundersen Lutheran Medical Center
  - Marinette, Wisconsin, United States, 54143
    - Recruiting
    - Aurora Bay Area Medical Group-Marinette
  - Milwaukee, Wisconsin, United States, 53209
    - Recruiting
    - Aurora Cancer Care-Milwaukee
  - Milwaukee, Wisconsin, United States, 53215
    - Recruiting
    - Aurora Saint Luke's Medical Center
  - Milwaukee, Wisconsin, United States, 53233
    - Recruiting
    - Aurora Sinai Medical Center
  - Oshkosh, Wisconsin, United States, 54904
    - Recruiting
    - Vince Lombardi Cancer Clinic - Oshkosh
  - Racine, Wisconsin, United States, 53406
    - Recruiting
    - Aurora Cancer Care-Racine
  - Sheboygan, Wisconsin, United States, 53081
    - Recruiting
    - Vince Lombardi Cancer Clinic-Sheboygan
  - Summit, Wisconsin, United States, 53066
    - Recruiting
    - Aurora Medical Center in Summit
  - Two Rivers, Wisconsin, United States, 54241
    - Recruiting
    - Vince Lombardi Cancer Clinic-Two Rivers
  - Wauwatosa, Wisconsin, United States, 53226
    - Recruiting
    - Aurora Cancer Care-Milwaukee West
  - West Allis, Wisconsin, United States, 53227
    - Recruiting
    - Aurora West Allis Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

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
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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A (carboplatin, pemetrexed, selpercatinib) 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. Patients also selpercatinib PO BID in the absence of disease progression or unacceptable toxicity.	Drug: Carboplatin Given IV Other Names: Blastocarb Carboplat Carboplatin Hexal Carboplatino Carboplatinum Carbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 Nealorin Novoplatinum Paraplatin Paraplatin AQ Paraplatine Platinwas Ribocarbo Drug: Selpercatinib Given PO Other Names: LOXO-292 RET Kinase Inhibitor LOXO-292 Retevmo WHO 10967 Drug: Pemetrexed Given IV Other Names: MTA Multitargeted Antifolate Pemfexy
Active Comparator: Arm B (carboplatin, pemetrexed) 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.	Drug: Carboplatin Given IV Other Names: Blastocarb Carboplat Carboplatin Hexal Carboplatino Carboplatinum Carbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 Nealorin Novoplatinum Paraplatin Paraplatin AQ Paraplatine Platinwas Ribocarbo Drug: Pemetrexed Given IV Other Names: MTA Multitargeted Antifolate Pemfexy

Participant Group / Arm

Intervention / Treatment

Experimental: Arm A (carboplatin, pemetrexed, selpercatinib)

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. Patients also selpercatinib PO BID in the absence of disease progression or unacceptable toxicity.

Drug: Carboplatin

Given IV

Other Names:

Blastocarb
Carboplat
Carboplatin Hexal
Carboplatino
Carboplatinum
Carbosin
Carbosol
Carbotec
CBDCA
Displata
Ercar
JM-8
Nealorin
Novoplatinum
Paraplatin
Paraplatin AQ
Paraplatine
Platinwas
Ribocarbo

Drug: Selpercatinib

Given PO

Other Names:

LOXO-292
RET Kinase Inhibitor LOXO-292
Retevmo
WHO 10967

Drug: Pemetrexed

Given IV

Other Names:

MTA
Multitargeted Antifolate
Pemfexy

Active Comparator: Arm B (carboplatin, pemetrexed)

Drug: Carboplatin

Given IV

Other Names:

Blastocarb
Carboplat
Carboplatin Hexal
Carboplatino
Carboplatinum
Carbosin
Carbosol
Carbotec
CBDCA
Displata
Ercar
JM-8
Nealorin
Novoplatinum
Paraplatin
Paraplatin AQ
Paraplatine
Platinwas
Ribocarbo

Drug: Pemetrexed

Given IV

Other Names:

MTA
Multitargeted Antifolate
Pemfexy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of grade 3 or higher non hematologic toxicity and grade 4 or higher hematologic toxicity Time Frame: During first cycle (1 cycle = 21 days)		During first cycle (1 cycle = 21 days)
Frequency and severity of adverse events Time Frame: Up to 3 years		Up to 3 years
Investigator-assessed objective response rate Time Frame: Up to 3 years		Up to 3 years
Overall survival Time Frame: From date of sub-study randomization to date of death due to any cause, assessed up to 3 years	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.	From date of sub-study randomization to date of death due to any cause, assessed up to 3 years
Duration of investigator-assessed response Time Frame: 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	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.	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Yasir Y Elamin, Southwest Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2022

Primary Completion (Anticipated)

May 1, 2028

Study Completion (Anticipated)

May 1, 2029

Study Registration Dates

First Submitted

May 3, 2022

First Submitted That Met QC Criteria

May 3, 2022

First Posted (Actual)

May 6, 2022

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

S1900F (Other Identifier: CTEP)
U10CA180888 (U.S. NIH Grant/Contract)
NCI-2022-02517 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Anticipated)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Anticipated)

Study Completion (Anticipated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

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Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations