Testing the Use of Targeted Treatment for RET Positive Advanced Non-small Cell Lung Cancer
Purpose
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.
Conditions
- Lung Non-Small Cell Carcinoma
- Recurrent Lung Non-Small Cell Carcinoma
- Stage IV Lung Cancer AJCC v8
- Stage IVA Lung Cancer AJCC v8
- Stage IVB Lung Cancer AJCC v8
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
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. |
|
Recruiting Locations
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas 72401
Jonesboro, Arkansas 72401
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274
Site Public Contact
501-686-8274
Kaiser Permanente-Anaheim
Anaheim, California 92806
Anaheim, California 92806
Sutter Auburn Faith Hospital
Auburn, California 95602
Auburn, California 95602
Kaiser Permanente-Baldwin Park
Baldwin Park, California 91706
Baldwin Park, California 91706
Kaiser Permanente-Bellflower
Bellflower, California 90706
Bellflower, California 90706
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California 94704
Berkeley, California 94704
Kaiser Permanente-Fontana
Fontana, California 92335
Fontana, California 92335
Palo Alto Medical Foundation-Fremont
Fremont, California 94538
Fremont, California 94538
Kaiser Permanente - Harbor City
Harbor City, California 90710
Harbor City, California 90710
Kaiser Permanente-Irvine
Irvine, California 92618
Irvine, California 92618
Loma Linda University Medical Center
Loma Linda, California 92354
Loma Linda, California 92354
Contact:
Site Public Contact
909-558-4050
Site Public Contact
909-558-4050
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
Los Angeles, California 90027
Kaiser Permanente West Los Angeles
Los Angeles, California 90034
Los Angeles, California 90034
Kaiser Permanente-Ontario
Ontario, California 91761
Ontario, California 91761
Palo Alto Medical Foundation Health Care
Palo Alto, California 94301
Palo Alto, California 94301
Kaiser Permanente - Panorama City
Panorama City, California 91402
Panorama City, California 91402
Kaiser Permanente-Riverside
Riverside, California 92505
Riverside, California 92505
Sutter Roseville Medical Center
Roseville, California 95661
Roseville, California 95661
Sutter Medical Center Sacramento
Sacramento, California 95816
Sacramento, California 95816
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
Sacramento, California 95817
Contact:
Site Public Contact
916-734-3089
Site Public Contact
916-734-3089
Saint Helena Hospital
Saint Helena, California 94574
Saint Helena, California 94574
Contact:
Site Public Contact
707-967-3698
Site Public Contact
707-967-3698
Kaiser Permanente-San Diego Zion
San Diego, California 92120
San Diego, California 92120
California Pacific Medical Center-Pacific Campus
San Francisco, California 94115
San Francisco, California 94115
Veterans Affairs Medical Center - San Francisco
San Francisco, California 94121
San Francisco, California 94121
Contact:
Site Public Contact
415-221-4810
Site Public Contact
415-221-4810
Kaiser Permanente-San Marcos
San Marcos, California 92078
San Marcos, California 92078
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California 94086
Sunnyvale, California 94086
Sutter Solano Medical Center/Cancer Center
Vallejo, California 94589
Vallejo, California 94589
Presbyterian Intercommunity Hospital
Whittier, California 90602
Whittier, California 90602
Contact:
Site Public Contact
562-698-0811
Site Public Contact
562-698-0811
Kaiser Permanente-Woodland Hills
Woodland Hills, California 91367
Woodland Hills, California 91367
Mount Sinai Medical Center
Miami Beach, Florida 33140
Miami Beach, Florida 33140
Moffitt Cancer Center
Tampa, Florida 33612
Tampa, Florida 33612
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
Boise, Idaho 83706
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
Boise, Idaho 83712
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
Caldwell, Idaho 83605
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
Coeur d'Alene, Idaho 83814
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
Fruitland, Idaho 83619
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
Meridian, Idaho 83642
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83686
Nampa, Idaho 83686
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho 83687
Nampa, Idaho 83687
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
Post Falls, Idaho 83854
Kootenai Cancer Clinic
Sandpoint, Idaho 83864
Sandpoint, Idaho 83864
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301
Twin Falls, Idaho 83301
Advocate Good Shepherd Hospital
Barrington, Illinois 60010
Barrington, Illinois 60010
Contact:
Site Public Contact
847-842-4847
Site Public Contact
847-842-4847
Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Bloomington, Illinois 61704
Illinois CancerCare-Canton
Canton, Illinois 61520
Canton, Illinois 61520
Illinois CancerCare-Carthage
Carthage, Illinois 62321
Carthage, Illinois 62321
Centralia Oncology Clinic
Centralia, Illinois 62801
Centralia, Illinois 62801
Northwestern University
Chicago, Illinois 60611
Chicago, Illinois 60611
Advocate Illinois Masonic Medical Center
Chicago, Illinois 60657
Chicago, Illinois 60657
Contact:
Site Public Contact
773-296-5360
Site Public Contact
773-296-5360
AMG Crystal Lake - Oncology
Crystal Lake, Illinois 60014
Crystal Lake, Illinois 60014
Carle on Vermilion
Danville, Illinois 61832
Danville, Illinois 61832
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Decatur, Illinois 62526
Decatur Memorial Hospital
Decatur, Illinois 62526
Decatur, Illinois 62526
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
DeKalb, Illinois 60115
Illinois CancerCare-Dixon
Dixon, Illinois 61021
Dixon, Illinois 61021
Contact:
Site Public Contact
815-285-7800
Site Public Contact
815-285-7800
Advocate Good Samaritan Hospital
Downers Grove, Illinois 60515
Downers Grove, Illinois 60515
Carle Physician Group-Effingham
Effingham, Illinois 62401
Effingham, Illinois 62401
Crossroads Cancer Center
Effingham, Illinois 62401
Effingham, Illinois 62401
Advocate Sherman Hospital
Elgin, Illinois 60123
Elgin, Illinois 60123
Contact:
Site Public Contact
847-429-2907
Site Public Contact
847-429-2907
Illinois CancerCare-Eureka
Eureka, Illinois 61530
Eureka, Illinois 61530
Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Galesburg, Illinois 61401
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
Geneva, Illinois 60134
Advocate South Suburban Hospital
Hazel Crest, Illinois 60429
Hazel Crest, Illinois 60429
Contact:
Site Public Contact
708-799-9995
Site Public Contact
708-799-9995
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
Kewanee, Illinois 61443
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois 60045
Lake Forest, Illinois 60045
AMG Libertyville - Oncology
Libertyville, Illinois 60048
Libertyville, Illinois 60048
Condell Memorial Hospital
Libertyville, Illinois 60048
Libertyville, Illinois 60048
Illinois CancerCare-Macomb
Macomb, Illinois 61455
Macomb, Illinois 61455
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
Mattoon, Illinois 61938
Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
Advocate Christ Medical Center
Oak Lawn, Illinois 60453-2699
Oak Lawn, Illinois 60453-2699
Contact:
Site Public Contact
800-323-8622
Site Public Contact
800-323-8622
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Ottawa, Illinois 61350
Advocate Lutheran General Hospital
Park Ridge, Illinois 60068
Park Ridge, Illinois 60068
Contact:
Site Public Contact
847-384-3621
Site Public Contact
847-384-3621
Illinois CancerCare-Pekin
Pekin, Illinois 61554
Pekin, Illinois 61554
Illinois CancerCare-Peoria
Peoria, Illinois 61615
Peoria, Illinois 61615
Illinois CancerCare-Peru
Peru, Illinois 61354
Peru, Illinois 61354
Illinois CancerCare-Princeton
Princeton, Illinois 61356
Princeton, Illinois 61356
Southern Illinois University School of Medicine
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929
Site Public Contact
217-545-7929
Springfield Clinic
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541
Site Public Contact
800-444-7541
Memorial Medical Center
Springfield, Illinois 62781
Springfield, Illinois 62781
Carle Cancer Center
Urbana, Illinois 61801
Urbana, Illinois 61801
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
Warrenville, Illinois 60555
Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
Des Moines, Iowa 50314
HaysMed University of Kansas Health System
Hays, Kansas 67601
Hays, Kansas 67601
Contact:
Site Public Contact
785-623-5774
Site Public Contact
785-623-5774
University of Kansas Cancer Center
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Lawrence Memorial Hospital
Lawrence, Kansas 66044
Lawrence, Kansas 66044
Olathe Health Cancer Center
Olathe, Kansas 66061
Olathe, Kansas 66061
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas 66210
Overland Park, Kansas 66210
Salina Regional Health Center
Salina, Kansas 67401
Salina, Kansas 67401
University of Kansas Health System Saint Francis Campus
Topeka, Kansas 66606
Topeka, Kansas 66606
Contact:
Site Public Contact
785-295-8000
Site Public Contact
785-295-8000
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
Westwood, Kansas 66205
University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
Lexington, Kentucky 40536
UPMC Western Maryland
Cumberland, Maryland 21502
Cumberland, Maryland 21502
Contact:
Site Public Contact
240-964-1400
Site Public Contact
240-964-1400
Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48106
Bronson Battle Creek
Battle Creek, Michigan 49017
Battle Creek, Michigan 49017
Saint Joseph Mercy Brighton
Brighton, Michigan 48114
Brighton, Michigan 48114
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
Brighton, Michigan 48114
Saint Joseph Mercy Canton
Canton, Michigan 48188
Canton, Michigan 48188
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
Canton, Michigan 48188
Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Ascension Saint John Hospital
Detroit, Michigan 48236
Detroit, Michigan 48236
Great Lakes Cancer Management Specialists-Doctors Park
East China Township, Michigan 48054
East China Township, Michigan 48054
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan 48503
Flint, Michigan 48503
Genesee Hematology Oncology PC
Flint, Michigan 48503
Flint, Michigan 48503
Genesys Hurley Cancer Institute
Flint, Michigan 48503
Flint, Michigan 48503
Hurley Medical Center
Flint, Michigan 48503
Flint, Michigan 48503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Academic Hematology Oncology Specialists
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
Bronson Methodist Hospital
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
West Michigan Cancer Center
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
Sparrow Hospital
Lansing, Michigan 48912
Lansing, Michigan 48912
Contact:
Site Public Contact
517-364-9400
Site Public Contact
517-364-9400
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
Livonia, Michigan 48154
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan 48044
Macomb, Michigan 48044
Trinity Health Muskegon Hospital
Muskegon, Michigan 49444
Muskegon, Michigan 49444
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan 49444
Norton Shores, Michigan 49444
Spectrum Health Reed City Hospital
Reed City, Michigan 49677
Reed City, Michigan 49677
Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
Saint Joseph, Michigan 49085
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan 48312
Sterling Heights, Michigan 48312
Munson Medical Center
Traverse City, Michigan 49684
Traverse City, Michigan 49684
Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren, Michigan 48093
Warren, Michigan 48093
Saint John Macomb-Oakland Hospital
Warren, Michigan 48093
Warren, Michigan 48093
Metro Health Hospital
Wyoming, Michigan 49519
Wyoming, Michigan 49519
Huron Gastroenterology PC
Ypsilanti, Michigan 48106
Ypsilanti, Michigan 48106
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
Ypsilanti, Michigan 48197
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
Bemidji, Minnesota 56601
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota 56401
Brainerd, Minnesota 56401
Mercy Hospital
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
Essentia Health - Deer River Clinic
Deer River, Minnesota 56636
Deer River, Minnesota 56636
Essentia Health Cancer Center
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Fairview Southdale Hospital
Edina, Minnesota 55435
Edina, Minnesota 55435
Essentia Health Hibbing Clinic
Hibbing, Minnesota 55746
Hibbing, Minnesota 55746
Contact:
Site Public Contact
218-786-3308
Site Public Contact
218-786-3308
Minneapolis VA Medical Center
Minneapolis, Minnesota 55417
Minneapolis, Minnesota 55417
Contact:
Site Public Contact
612-467-2800
Site Public Contact
612-467-2800
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
Saint Louis Park, Minnesota 55416
Regions Hospital
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55101
United Hospital
Saint Paul, Minnesota 55102
Saint Paul, Minnesota 55102
Essentia Health Sandstone
Sandstone, Minnesota 55072
Sandstone, Minnesota 55072
Essentia Health Virginia Clinic
Virginia, Minnesota 55792
Virginia, Minnesota 55792
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi 39705
Columbus, Mississippi 39705
Baptist Cancer Center-Grenada
Grenada, Mississippi 38901
Grenada, Mississippi 38901
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi 38652
New Albany, Mississippi 38652
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi 38655
Oxford, Mississippi 38655
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi 38671
Southhaven, Mississippi 38671
Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
Parkland Health Center - Farmington
Farmington, Missouri 63640
Farmington, Missouri 63640
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Truman Medical Centers
Kansas City, Missouri 64108
Kansas City, Missouri 64108
Contact:
Site Public Contact
816-404-4375
Site Public Contact
816-404-4375
University of Kansas Cancer Center - North
Kansas City, Missouri 64154
Kansas City, Missouri 64154
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri 64064
Lee's Summit, Missouri 64064
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri 64116
North Kansas City, Missouri 64116
Missouri Baptist Medical Center
Saint Louis, Missouri 63131
Saint Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
Sainte Genevieve, Missouri 63670
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
Sullivan, Missouri 63080
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri 63127
Sunset Hills, Missouri 63127
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Community Hospital of Anaconda
Anaconda, Montana 59711
Anaconda, Montana 59711
Billings Clinic Cancer Center
Billings, Montana 59101
Billings, Montana 59101
Bozeman Deaconess Hospital
Bozeman, Montana 59715
Bozeman, Montana 59715
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
Great Falls, Montana 59405
Kalispell Regional Medical Center
Kalispell, Montana 59901
Kalispell, Montana 59901
Community Medical Hospital
Missoula, Montana 59804
Missoula, Montana 59804
OptumCare Cancer Care at Charleston
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire 03301
Concord, New Hampshire 03301
Contact:
Site Public Contact
603-224-2556
Site Public Contact
603-224-2556
Solinsky Center for Cancer Care
Manchester, New Hampshire 03103
Manchester, New Hampshire 03103
Contact:
Site Public Contact
800-339-6484
Site Public Contact
800-339-6484
Virtua Samson Cancer Center
Moorestown, New Jersey 08057
Moorestown, New Jersey 08057
Contact:
Site Public Contact
856-247-7395
Site Public Contact
856-247-7395
Virtua Voorhees
Voorhees, New Jersey 08043
Voorhees, New Jersey 08043
Contact:
Site Public Contact
856-247-7395
Site Public Contact
856-247-7395
University of New Mexico Cancer Center
Albuquerque, New Mexico 87102
Albuquerque, New Mexico 87102
University of Rochester
Rochester, New York 14642
Rochester, New York 14642
Contact:
Site Public Contact
585-275-5830
Site Public Contact
585-275-5830
AdventHealth Infusion Center Asheville
Asheville, North Carolina 28803
Asheville, North Carolina 28803
AdventHealth Infusion Center Haywood
Clyde, North Carolina 28721
Clyde, North Carolina 28721
AdventHealth Hendersonville
Hendersonville, North Carolina 28792
Hendersonville, North Carolina 28792
AdventHealth Infusion Center Weaverville
Weaverville, North Carolina 28787
Weaverville, North Carolina 28787
Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota 58103
Fargo, North Dakota 58103
Sanford Broadway Medical Center
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Aultman Health Foundation
Canton, Ohio 44710
Canton, Ohio 44710
Miami Valley Hospital South
Centerville, Ohio 45459
Centerville, Ohio 45459
Miami Valley Hospital
Dayton, Ohio 45409
Dayton, Ohio 45409
Miami Valley Hospital North
Dayton, Ohio 45415
Dayton, Ohio 45415
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
Franklin, Ohio 45005-1066
Trinity's Tony Teramana Cancer Center
Steubenville, Ohio 43952
Steubenville, Ohio 43952
Contact:
Site Public Contact
888-874-7000
Site Public Contact
888-874-7000
ProMedica Flower Hospital
Sylvania, Ohio 43560
Sylvania, Ohio 43560
Upper Valley Medical Center
Troy, Ohio 45373
Troy, Ohio 45373
Saint Alphonsus Medical Center-Ontario
Ontario, Oregon 97914
Ontario, Oregon 97914
Kaiser Permanente Northwest
Portland, Oregon 97227
Portland, Oregon 97227
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania 15009
Beaver, Pennsylvania 15009
UPMC Hillman Cancer Center at Butler Health System
Butler, Pennsylvania 16001
Butler, Pennsylvania 16001
UPMC Camp Hill
Camp Hill, Pennsylvania 17011
Camp Hill, Pennsylvania 17011
Contact:
Site Public Contact
717-975-8900
Site Public Contact
717-975-8900
Carlisle Regional Cancer Center
Carlisle, Pennsylvania 17015
Carlisle, Pennsylvania 17015
WellSpan Medical Oncology and Hematology
Chambersburg, Pennsylvania 17201
Chambersburg, Pennsylvania 17201
Contact:
Site Public Contact
717-217-6020
Site Public Contact
717-217-6020
UPMC Hillman Cancer Center - Passavant - Cranberry
Cranberry Township, Pennsylvania 16066
Cranberry Township, Pennsylvania 16066
Ephrata Cancer Center
Ephrata, Pennsylvania 17522
Ephrata, Pennsylvania 17522
Contact:
Site Public Contact
717-721-4840
Site Public Contact
717-721-4840
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania 16505
Erie, Pennsylvania 16505
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania 16121
Farrell, Pennsylvania 16121
Adams Cancer Center
Gettysburg, Pennsylvania 17325
Gettysburg, Pennsylvania 17325
Contact:
Site Public Contact
877-441-7957
Site Public Contact
877-441-7957
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania 15601
Greensburg, Pennsylvania 15601
Contact:
Site Public Contact
724-838-1900
Site Public Contact
724-838-1900
Oncology Hematology Associates
Greenville, Pennsylvania 16125
Greenville, Pennsylvania 16125
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania 17109
Harrisburg, Pennsylvania 17109
IRMC Cancer Center
Indiana, Pennsylvania 15701
Indiana, Pennsylvania 15701
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania 15901
Johnstown, Pennsylvania 15901
Contact:
Site Public Contact
814-534-4724
Site Public Contact
814-534-4724
Sechler Family Cancer Center
Lebanon, Pennsylvania 17042
Lebanon, Pennsylvania 17042
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania 15132
McKeesport, Pennsylvania 15132
Contact:
Site Public Contact
412-647-8073
Site Public Contact
412-647-8073
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania 17050
Mechanicsburg, Pennsylvania 17050
UPMC Cancer Center - Monroeville
Monroeville, Pennsylvania 15146
Monroeville, Pennsylvania 15146
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania 15146
Monroeville, Pennsylvania 15146
UPMC Hillman Cancer Center in Coraopolis
Moon, Pennsylvania 15108
Moon, Pennsylvania 15108
Arnold Palmer Cancer Center Medical Oncology Norwin
N. Huntingdon, Pennsylvania 15642
N. Huntingdon, Pennsylvania 15642
UPMC Cancer Center-Natrona Heights
Natrona Heights, Pennsylvania 15065
Natrona Heights, Pennsylvania 15065
Contact:
Site Public Contact
724-230-3030
Site Public Contact
724-230-3030
UPMC Hillman Cancer Center - New Castle
New Castle, Pennsylvania 16105
New Castle, Pennsylvania 16105
UPMC-Saint Margaret
Pittsburgh, Pennsylvania 15215
Pittsburgh, Pennsylvania 15215
Contact:
Site Public Contact
412-784-4900
Site Public Contact
412-784-4900
UPMC-Mercy Hospital
Pittsburgh, Pennsylvania 15219
Pittsburgh, Pennsylvania 15219
Contact:
Site Public Contact
800-533-8762
Site Public Contact
800-533-8762
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-647-8073
Site Public Contact
412-647-8073
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania 15237
Pittsburgh, Pennsylvania 15237
Contact:
Site Public Contact
412-367-6454
Site Public Contact
412-367-6454
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania 15243
Pittsburgh, Pennsylvania 15243
Contact:
Site Public Contact
412-502-3920
Site Public Contact
412-502-3920
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania 16346
Seneca, Pennsylvania 16346
Contact:
Site Public Contact
814-676-7900
Site Public Contact
814-676-7900
UPMC Cancer Center-Uniontown
Uniontown, Pennsylvania 15401
Uniontown, Pennsylvania 15401
UPMC Uniontown Hospital Radiation Oncology
Uniontown, Pennsylvania 15401
Uniontown, Pennsylvania 15401
Contact:
Site Public Contact
724-437-2503
Site Public Contact
724-437-2503
UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania 15301
Washington, Pennsylvania 15301
UPMC West Mifflin-Cancer Center Jefferson
West Mifflin, Pennsylvania 15122
West Mifflin, Pennsylvania 15122
Contact:
Site Public Contact
412-653-8100
Site Public Contact
412-653-8100
WellSpan Health-York Cancer Center
York, Pennsylvania 17403
York, Pennsylvania 17403
Contact:
Site Public Contact
877-441-7957
Site Public Contact
877-441-7957
WellSpan Health-York Hospital
York, Pennsylvania 17403
York, Pennsylvania 17403
Contact:
Site Public Contact
877-441-7957
Site Public Contact
877-441-7957
UPMC Memorial
York, Pennsylvania 17408
York, Pennsylvania 17408
Contact:
Site Public Contact
717-724-6760
Site Public Contact
717-724-6760
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina 29316
Boiling Springs, South Carolina 29316
Contact:
Site Public Contact
864-241-6251
Site Public Contact
864-241-6251
Ralph H Johnson VA Medical Center
Charleston, South Carolina 29401
Charleston, South Carolina 29401
Medical University of South Carolina
Charleston, South Carolina 29425
Charleston, South Carolina 29425
Prisma Health Cancer Institute - Easley
Easley, South Carolina 29640
Easley, South Carolina 29640
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina 29605
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-241-6251
Site Public Contact
864-241-6251
Prisma Health Cancer Institute - Faris
Greenville, South Carolina 29605
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-241-6251
Site Public Contact
864-241-6251
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina 29605
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-241-6251
Site Public Contact
864-241-6251
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina 29615
Greenville, South Carolina 29615
Contact:
Site Public Contact
864-241-6251
Site Public Contact
864-241-6251
Prisma Health Cancer Institute - Greer
Greer, South Carolina 29650
Greer, South Carolina 29650
Contact:
Site Public Contact
864-241-6251
Site Public Contact
864-241-6251
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina 29672
Seneca, South Carolina 29672
Contact:
Site Public Contact
864-241-6251
Site Public Contact
864-241-6251
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Sioux Falls, South Dakota 57117-5134
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee 38017
Collierville, Tennessee 38017
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee 38120
Memphis, Tennessee 38120
Duluth Clinic Ashland
Ashland, Wisconsin 54806
Ashland, Wisconsin 54806
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin 53105
Burlington, Wisconsin 53105
Aurora Health Care Germantown Health Center
Germantown, Wisconsin 53022
Germantown, Wisconsin 53022
Aurora Cancer Care-Grafton
Grafton, Wisconsin 53024
Grafton, Wisconsin 53024
Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
Green Bay, Wisconsin 54311
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin 53142
Kenosha, Wisconsin 53142
Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
La Crosse, Wisconsin 54601
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin 54143
Marinette, Wisconsin 54143
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin 53209
Milwaukee, Wisconsin 53209
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53215
Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
Milwaukee, Wisconsin 53233
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
Oshkosh, Wisconsin 54904
Aurora Cancer Care-Racine
Racine, Wisconsin 53406
Racine, Wisconsin 53406
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin 53081
Sheboygan, Wisconsin 53081
Aurora Medical Center in Summit
Summit, Wisconsin 53066
Summit, Wisconsin 53066
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin 54241
Two Rivers, Wisconsin 54241
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin 53226
Wauwatosa, Wisconsin 53226
Aurora West Allis Medical Center
West Allis, Wisconsin 53227
West Allis, Wisconsin 53227
More Details
- NCT ID
- NCT05364645
- Status
- Recruiting
- Sponsor
- SWOG Cancer Research Network
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.