Purpose

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

Conditions

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients must have been assigned to S1900B based on biomarker analysis of tissue and/or blood and determined to have RET fusion-positive NSCLC as defined here: - Patients must have RET fusion-positive NSCLC as determined by the Foundation Medicine (FMI) tissue-assay, other tumor-based assays such as next-generation sequencing (NGS), polymerase chain reaction (PCR), or follicular in situ hybridization (FISH), or by cfDNA blood assay. Patients with RET fusions detected by immunohistochemistry (IHC) alone are not eligible. The testing must be done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO/International Electrotechnical Commission (IEC), College of American Pathologists (CAP), or similar certification. Presence of RET fusions detected on tests performed outside of LUNGMAP must have been confirmed by the study biomarker review panel - For patients whose prior therapy was for stage IV or recurrent disease, the patient must have received at least one line of a platinum-based chemotherapy regimen. For patients whose prior systemic therapy was for stage I-III disease only (i.e. patient has not received any treatment for stage IV or recurrent disease), disease progression on platinum-based chemotherapy must have occurred within one year from the last date that the patient received that therapy. Prior anti-PD-1/PD-L1 therapy, alone or in combination (e.g. nivolumab, pembrolizumab, or durvalumab) is allowed - Patients must be negative for all additional validated oncogenic drivers that could cause resistance to LOXO-292 treatment. This includes EGFR sensitizing mutations, EGFR T790M, ALK gene fusion, ROS1 gene fusion, KRAS activating mutation, BRAF V600E mutation and MET exon 14 skipping mutation or high-level amplification and expression - Note: EGFR, ALK, ROS, KRAS, and BRAF testing is performed as part of the LUNGMAP screening/pre-screening FoundationOne test. If prior data is not available, results from the FMI testing must be obtained prior to sub-study registration - Patients must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI). The CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to sub-study registration. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to sub-study registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form. Patients whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration. CT and MRI scans must be submitted for central review via transfer of images and data (TRIAD) - Patients must have a CT or MRI scan of the brain to evaluate for CNS disease within 42 days prior to sub-study registration - Patients with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration - Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment must have an undetectable HCV viral load within 28 days prior to registration - Patients with known human immunodeficiency virus (HIV) infection are eligible, provided they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to registration - Patients must be able to swallow capsules - Patients must have progressed (in the opinion of the treating physician) following the most recent line of therapy - Patients must have recovered (=< grade 1) from any side effects of prior therapy. Patients must not have received any radiation therapy within 14 days prior to sub-study registration - Absolute neutrophil count (ANC) >= 1,500/mcl (obtained within 28 days prior to sub-study registration) - Platelet count >= 100,000 mcl (obtained within 28 days prior to sub-study registration) - Serum bilirubin =< institutional upper limit of normal (IULN) (within 28 days prior to sub-study registration). For patients with liver metastases, bilirubin must be =< 5 x IULN - Either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 2 x IULN (within 28 days prior to sub-study registration) (if both ALT and AST are done, both must be =< 2 IULN). For patients with liver metastases, bilirubin and either ALT or AST must be =< 5 x IULN (if both ALT and AST are done, both must be =< 5 x IULN) - Serum creatinine =< the IULN or calculated creatinine clearance >= 50 mL/min using the following Cockcroft-Gault formula (within 28 days prior to sub-study registration) - Patients must have Zubrod performance status 0-1 documented within 28 days prior to sub-study registration - Pre-study history and physical exam must be obtained within 28 days prior to sub-study registration - No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years - Patients must have electrolytes and blood urea nitrogen (BUN) performed within 14 days prior to sub-study registration - Patients must agree to have blood specimens submitted for circulating tumor DNA (ctDNA) - Patients must also be offered participation in banking and in the correlative studies for collection and future use of specimens - Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines - As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system - Patients with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)

Exclusion Criteria

  • Patients must not have received any prior treatment with selective anti-RET inhibitors (anti-RET multikinase inhibitors are permitted) - Patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to registration, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to sub-study registration - Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 14 days prior to sub-study registration - Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study. Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable - Patient must not have had a major surgery within 14 days prior to sub-study registration. Patient must have fully recovered from the effects of prior surgery in the opinion of the treating investigator - Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia - Patients must not have a QT interval by Fridericia (QTcF) > 470 msec based on the electrocardiogram (ECG) within 28 days prior to registration. It is suggested that a local cardiologist review the QTcF intervals - Patients must not have any clinically significant uncontrolled systemic illness, including but not limited to uncontrolled infection, requiring intravenous antibiotics, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmias, uncontrolled hypertension, or uncontrolled diabetes mellitus - Uncontrolled diabetes: Patients who have a diagnosis of diabetes must have an hemoglobin (Hb) A1C < 7% within 28 days prior to registration. The same criterion will be used in patients with confirmed diagnosis of diabetes mellitus who have been on a stable dietary or therapeutic regimen for this condition in the last three months - Uncontrolled blood pressure and hypertension: All blood pressure measurements within the 28 days prior to registration must be systolic blood pressure (SBP) =< 180 and diastolic blood pressure (DBP) =< 100. An exception can be made by a healthcare provider for a patient with a single blood pressure elevation who upon rechecking has a blood pressure within the parameters above - Patients must not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of LOXO-292 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or active peptic ulcer disease) - Patients must not be planning to receive any strong inhibitors or inducers of CYP3A4 at least 14 days prior to sub-study registration and throughout protocol treatment - Patients must not be planning to use proton pump inhibitors (PPIs) at least one week prior to sub-study registration and throughout protocol treatment - Patients must not be pregnant or nursing. Women study patients of reproductive potential and fertile men study patients and their partners must abstain or use effective contraception (including barrier method) while receiving study treatment and for at least 3 months after the last dose of LOXO-292. Male study patients must agree not to donate sperm for 6 months after the last dose of LOXO-292. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment (selpercatinib)
Patients receive selpercatinib orally PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Drug: Selpercatinib
    Given PO
    Other names:
    • LOXO-292
    • RET Kinase Inhibitor LOXO-292

Recruiting Locations

Fairbanks Memorial Hospital
Fairbanks, Alaska 99701
Contact:
Site Public Contact
907-458-3043
cancerresearch@foundationhealth.org

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274

Kaiser Permanente-Anaheim
Anaheim, California 92806
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Sutter Auburn Faith Hospital
Auburn, California 95602
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente-Baldwin Park
Baldwin Park, California 91706
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente-Bellflower
Bellflower, California 90706
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California 94704
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente-Fontana
Fontana, California 92335
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Palo Alto Medical Foundation-Fremont
Fremont, California 94538
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente - Harbor City
Harbor City, California 90710
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente-Irvine
Irvine, California 92618
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente-Cadillac
Los Angeles, California 90034
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Palo Alto Medical Foundation-Camino Division
Mountain View, California 94040
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente-Ontario
Ontario, California 91761
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Palo Alto Medical Foundation Health Care
Palo Alto, California 94301
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente - Panorama City
Panorama City, California 91402
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente-Riverside
Riverside, California 92505
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Sutter Roseville Medical Center
Roseville, California 95661
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Sutter Medical Center Sacramento
Sacramento, California 95816
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
Contact:
Site Public Contact
916-734-3089

Kaiser Permanente-San Diego Zion
San Diego, California 92120
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

California Pacific Medical Center-Pacific Campus
San Francisco, California 94115
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente-San Marcos
San Marcos, California 92078
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California 95065
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Sutter Solano Medical Center/Cancer Center
Vallejo, California 94589
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Presbyterian Intercommunity Hospital
Whittier, California 90602
Contact:
Site Public Contact
562-698-0811

Kaiser Permanente-Woodland Hills
Woodland Hills, California 91367
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

University of Colorado Hospital
Aurora, Colorado 80045
Contact:
Site Public Contact
720-848-0650

Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado 80304
Contact:
Site Public Contact
303-777-2663
info@westernstatesncorp.org

UCHealth Memorial Hospital Central
Colorado Springs, Colorado 80909
Contact:
Site Public Contact
719-365-2406

Memorial Hospital North
Colorado Springs, Colorado 80920
Contact:
Site Public Contact
719-364-6700

Rocky Mountain Cancer Centers-Midtown
Denver, Colorado 80218
Contact:
Site Public Contact
303-777-2663
info@westernstatesncorp.org

Poudre Valley Hospital
Fort Collins, Colorado 80524
Contact:
Site Public Contact
970-297-6150

Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado 80528
Contact:
Site Public Contact
protocols@swog.org

North Colorado Medical Center
Greeley, Colorado 80631
Contact:
Site Public Contact
303-777-2663
info@westernstatesncorp.org

UCHealth Greeley Hospital
Greeley, Colorado 80631
Contact:
Site Public Contact
protocols@swog.org

UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado 80129
Contact:
Site Public Contact
720-848-0650

Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado 80120
Contact:
Site Public Contact
303-777-2663
info@westernstatesncorp.org

Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado 80124
Contact:
Site Public Contact
303-777-2663
info@westernstatesncorp.org

UCHealth Lone Tree Health Center
Lone Tree, Colorado 80124
Contact:
Site Public Contact
protocols@swog.org

Medical Center of the Rockies
Loveland, Colorado 80538
Contact:
Site Public Contact
970-203-7083

McKee Medical Center
Loveland, Colorado 80539
Contact:
Site Public Contact
303-777-2663
info@westernstatesncorp.org

Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida 33180
Contact:
Site Public Contact
305-674-2625
yenrique@msmc.com

Mount Sinai Medical Center
Miami Beach, Florida 33140
Contact:
Site Public Contact
305-674-2625
yenrique@msmc.com

Northside Hospital
Atlanta, Georgia 30342
Contact:
Site Public Contact
404-303-3355
ClinicalTrials@northside.com

Northeast Georgia Medical Center Braselton
Braselton, Georgia 30517
Contact:
Site Public Contact
770-219-8800
cancerpatient.navigator@nghs.com

Northside Hospital - Duluth
Duluth, Georgia 30096
Contact:
Site Public Contact
404-303-3355
Clinical.trials@northside.com

Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia 30501
Contact:
Site Public Contact
770-219-8800
cancerpatient.navigator@nghs.com

Northside Hospital - Gwinnett
Lawrenceville, Georgia 30046
Contact:
Site Public Contact
404-303-3355
Clinical.trials@northside.com

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia 31405
Contact:
Site Public Contact
912-819-5704
underberga@sjchs.org

Suburban Hematology Oncology Associates - Snellville
Snellville, Georgia 30078
Contact:
Site Public Contact
404-303-3355
Clinical.trials@northside.com

Hawaii Cancer Care - Savio
'Aiea, Hawaii 96701
Contact:
Site Public Contact
808-539-2273

Queen's Medical Center
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-545-8548

Straub Clinic and Hospital
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-522-4333

Saint Luke's Mountain States Tumor Institute
Boise, Idaho 83712
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83686
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Canton
Canton, Illinois 61520
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Carthage
Carthage, Illinois 62321
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Northwestern University
Chicago, Illinois 60611
Contact:
Site Public Contact
312-695-1301
cancer@northwestern.edu

Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4740
rhamrick@dmhhs.org

Illinois CancerCare-Dixon
Dixon, Illinois 61021
Contact:
Site Public Contact
815-285-7800

Crossroads Cancer Center
Effingham, Illinois 62401
Contact:
Site Public Contact
217-876-4740
rhamrick@dmhhs.org

Illinois CancerCare-Eureka
Eureka, Illinois 61530
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois 60201
Contact:
Site Public Contact
847-570-2109

Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois 60026
Contact:
Site Public Contact
847-570-2109

NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois 60035
Contact:
Site Public Contact
847-570-2109

Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Macomb
Macomb, Illinois 61455
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Pekin
Pekin, Illinois 61554
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peoria
Peoria, Illinois 61615
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peru
Peru, Illinois 61354
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Princeton
Princeton, Illinois 61356
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Genesis Cancer Center - Silvis
Silvis, Illinois 61282
Contact:
Site Public Contact
563-421-1908
turnerk@genesishealth.com

Goshen Center for Cancer Care
Goshen, Indiana 46526
Contact:
Site Public Contact
574-364-2973
cccois@goshenhealth.com

Franciscan Health Indianapolis
Indianapolis, Indiana 46237
Contact:
Site Public Contact
317-528-7060

Franciscan Health Mooresville
Mooresville, Indiana 46158
Contact:
Site Public Contact
317-834-3603

Memorial Hospital of South Bend
South Bend, Indiana 46601
Contact:
Site Public Contact
800-284-7370

Mary Greeley Medical Center
Ames, Iowa 50010
Contact:
Site Public Contact
515-956-4132

McFarland Clinic PC - Ames
Ames, Iowa 50010
Contact:
Site Public Contact
515-239-4734
ksoder@mcfarlandclinic.com

McFarland Clinic PC-Boone
Boone, Iowa 50036
Contact:
Site Public Contact
515-956-4132

Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa 50325
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Mercy Cancer Center-West Lakes
Clive, Iowa 50325
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Greater Regional Medical Center
Creston, Iowa 50801
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Genesis Medical Center - East Campus
Davenport, Iowa 52803
Contact:
Site Public Contact
563-421-1908
turnerk@genesishealth.com

Genesis Cancer Care Institute
Davenport, Iowa 52804
Contact:
Site Public Contact
563-421-1908
turnerk@genesishealth.com

Iowa Cancer Specialists
Davenport, Iowa 52807
Contact:
Site Public Contact
563-421-1908
turnerk@genesishealth.com

Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa 50314
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

McFarland Clinic PC-Trinity Cancer Center
Fort Dodge, Iowa 50501
Contact:
Site Public Contact
515-956-4132

McFarland Clinic PC-Jefferson
Jefferson, Iowa 50129
Contact:
Site Public Contact
515-956-4132

McFarland Clinic PC-Marshalltown
Marshalltown, Iowa 50158
Contact:
Site Public Contact
515-956-4132

Mercy Medical Center-West Lakes
West Des Moines, Iowa 50266
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

University of Kansas Health System Saint Francis Campus
Topeka, Kansas 66606
Contact:
Site Public Contact
785-295-8000

University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
Contact:
Site Public Contact
859-257-3379

Medical Center of Baton Rouge
Baton Rouge, Louisiana 70816
Contact:
Site Public Contact
225-761-5346
Camille.Beck@Ochsner.org

Ochsner High Grove
Baton Rouge, Louisiana 70836
Contact:
Site Public Contact
504-703-8712
Gregory.Johnstone@ochsner.org

Ochsner Medical Center Kenner
Kenner, Louisiana 70065
Contact:
Site Public Contact
504-464-8314
cris.molina@ochsner.org

Ochsner Medical Center Jefferson
New Orleans, Louisiana 70121
Contact:
Site Public Contact
504-703-8712
Gregory.Johnstone@ochsner.org

Harold Alfond Center for Cancer Care
Augusta, Maine 04330
Contact:
Site Public Contact
207-626-4855

Waldo County General Hospital
Belfast, Maine 04915
Contact:
Site Public Contact
207-338-2500

MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
Biddeford, Maine 04005
Contact:
Site Public Contact
LLemire@mmc.org

Penobscot Bay Medical Center
Rockport, Maine 04856
Contact:
Site Public Contact
207-396-8670
ClinicalResearch@mmc.org

MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
Sanford, Maine 04073
Contact:
Site Public Contact
LLemire@mmc.org

Maine Medical Partners - South Portland
South Portland, Maine 04106
Contact:
Site Public Contact
207-396-8670
ClinicalResearch@mmc.org

UMass Memorial Medical Center - University Campus
Worcester, Massachusetts 01655
Contact:
Site Public Contact
508-856-3216
cancer.research@umassmed.edu

Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Bronson Battle Creek
Battle Creek, Michigan 49017
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

IHA Hematology Oncology Consultants-Brighton
Brighton, Michigan 48114
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Joseph Mercy Brighton
Brighton, Michigan 48114
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

IHA Hematology Oncology Consultants-Canton
Canton, Michigan 48188
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Joseph Mercy Canton
Canton, Michigan 48188
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

IHA Hematology Oncology Consultants-Chelsea
Chelsea, Michigan 48118
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan 48038
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Henry Ford Hospital
Detroit, Michigan 48202
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan 48503
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Genesee Hematology Oncology PC
Flint, Michigan 48503
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Genesys Hurley Cancer Institute
Flint, Michigan 48503
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Spectrum Health at Butterworth Campus
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Allegiance Health
Jackson, Michigan 49201
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

West Michigan Cancer Center
Kalamazoo, Michigan 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Sparrow Hospital
Lansing, Michigan 48912
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Hope Cancer Clinic
Livonia, Michigan 48154
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Mary Mercy Hospital
Livonia, Michigan 48154
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Spectrum Health Reed City Hospital
Reed City, Michigan 49677
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Ascension Saint Mary's Hospital
Saginaw, Michigan 48601
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan 48604
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Ascension Saint Joseph Hospital
Tawas City, Michigan 48764
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Munson Medical Center
Traverse City, Michigan 49684
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Metro Health Hospital
Wyoming, Michigan 49519
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti, Michigan 48197
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
Contact:
Site Public Contact
218-333-5000
OncologyClinicalTrialsFargo@sanfordhealth.org

Essentia Health - Deer River Clinic
Deer River, Minnesota 56636
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Cancer Center
Duluth, Minnesota 55805
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Hibbing Clinic
Hibbing, Minnesota 55746
Contact:
Site Public Contact
218-786-3308

Minneapolis VA Medical Center
Minneapolis, Minnesota 55417
Contact:
Site Public Contact
612-467-2800

United Hospital
Saint Paul, Minnesota 55102
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Essentia Health Sandstone
Sandstone, Minnesota 55072
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Virginia Clinic
Virginia, Minnesota 55792
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Parkland Health Center - Farmington
Farmington, Missouri 63640
Contact:
Site Public Contact
314-996-5569

Washington University School of Medicine
Saint Louis, Missouri 63110
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Siteman Cancer Center-South County
Saint Louis, Missouri 63129
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Missouri Baptist Medical Center
Saint Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Contact:
Site Public Contact
314-251-7066

Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri 63376
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
Contact:
Site Public Contact
314-996-5569

Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
Contact:
Site Public Contact
314-996-5569

Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri 63127
Contact:
Site Public Contact
314-996-5569

Community Hospital of Anaconda
Anaconda, Montana 59711
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

OptumCare Cancer Care at Oakey
Las Vegas, Nevada 89102
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada 89148
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Renown Regional Medical Center
Reno, Nevada 89502
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire 03301
Contact:
Site Public Contact
603-224-2556

Solinsky Center for Cancer Care
Manchester, New Hampshire 03103
Contact:
Site Public Contact
800-339-6484

Virtua Samson Cancer Center
Moorestown, New Jersey 08057
Contact:
Site Public Contact
856-247-7395

Virtua Voorhees
Voorhees, New Jersey 08043
Contact:
Site Public Contact
856-247-7395

University of New Mexico Cancer Center
Albuquerque, New Mexico 87102
Contact:
Site Public Contact
505-925-0366
LByatt@nmcca.org

New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico 87109
Contact:
Site Public Contact
505-272-0530
CLee@nmcca.org

Presbyterian Kaseman Hospital
Albuquerque, New Mexico 87110
Contact:
Site Public Contact
505-559-6113
WBurman@phs.org

Presbyterian Rust Medical Center/Jorgensen Cancer Center
Rio Rancho, New Mexico 87124
Contact:
Site Public Contact
505-559-6113
WBurman@phs.org

James J Peters VA Medical Center
Bronx, New York 10468
Contact:
Site Public Contact
718-584-9000
kl2965@cumc.columbia.edu

Mary Imogene Bassett Hospital
Cooperstown, New York 13326
Contact:
Site Public Contact
877-547-1750
CancerClinicalTrials@bassett.org

Arnot Ogden Medical Center/Falck Cancer Center
Elmira, New York 14905
Contact:
Site Public Contact
607-271-7000

Randolph Hospital
Asheboro, North Carolina 27203
Contact:
Site Public Contact
336-832-0836
vivian.sheidler@conehealth.com

Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina 27215
Contact:
Site Public Contact
336-538-7725
kaye.shoffner@conehealth.com

Rex Hematology Oncology Associates-Cary
Cary, North Carolina 27518
Contact:
Site Public Contact
919-784-7209

Rex Hematology Oncology Associates-Garner
Garner, North Carolina 27529
Contact:
Site Public Contact
919-784-7209

Cone Health Cancer Center
Greensboro, North Carolina 27403
Contact:
Site Public Contact
336-832-0821
vivian.sheidler@conehealth.com

Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina 28791
Contact:
Site Public Contact
828-696-4716
karen.morris@unchealth.unc.edu

Rex Cancer Center
Raleigh, North Carolina 27607
Contact:
Site Public Contact
919-784-7209

Rex Hematology Oncology Associates-Blue Ridge
Raleigh, North Carolina 27607
Contact:
Site Public Contact
919-784-7209

Rex Cancer Center of Wakefield
Raleigh, North Carolina 27614
Contact:
Site Public Contact
919-784-7209

Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
Contact:
Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Broadway Medical Center
Fargo, North Dakota 58122
Contact:
Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
Contact:
Site Public Contact
701-234-6161
OncologyClinicalTrialsFargo@sanfordhealth.org

Strecker Cancer Center-Belpre
Belpre, Ohio 45714
Contact:
Site Public Contact
800-523-3977
sheree@columbusccop.org

Adena Regional Medical Center
Chillicothe, Ohio 45601
Contact:
Site Public Contact
877-779-7585
sheree@columbusccop.org

Columbus Oncology and Hematology Associates Inc
Columbus, Ohio 43214
Contact:
Site Public Contact
614-488-2118
sheree@columbusccop.org

Grant Medical Center
Columbus, Ohio 43215
Contact:
Site Public Contact
614-566-4475
sheree@columbusccop.org

The Mark H Zangmeister Center
Columbus, Ohio 43219
Contact:
Site Public Contact
614-488-2118
sheree@columbusccop.org

Doctors Hospital
Columbus, Ohio 43228
Contact:
Site Public Contact
614-566-3275
sheree@columbusccop.org

Delaware Health Center-Grady Cancer Center
Delaware, Ohio 43015
Contact:
Site Public Contact
740-615-0227
sheree@columbusccop.org

Marietta Memorial Hospital
Marietta, Ohio 45750
Contact:
Site Public Contact
800-523-3977
sheree@columbusccop.org

OhioHealth Marion General Hospital
Marion, Ohio 43302
Contact:
Site Public Contact
614-488-2118
sheree@columbusccop.org

Licking Memorial Hospital
Newark, Ohio 43055
Contact:
Site Public Contact
740-348-4000
sheree@columbusccop.org

Southern Ohio Medical Center
Portsmouth, Ohio 45662
Contact:
Site Public Contact
614-488-2118
sheree@columbusccop.org

ProMedica Flower Hospital
Sylvania, Ohio 43560
Contact:
Site Public Contact
419-824-1842

Genesis Healthcare System Cancer Care Center
Zanesville, Ohio 43701
Contact:
Site Public Contact
740-454-5232
sheree@columbusccop.org

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

Kaiser Permanente Northwest
Portland, Oregon 97227
Contact:
Site Public Contact
503-335-2400
information@kpchr.org

Oregon Health and Science University
Portland, Oregon 97239
Contact:
Site Public Contact
503-494-1080
trials@ohsu.edu

Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
East Norriton, Pennsylvania 19401
Contact:
Site Public Contact
888-823-5923
ctsucontact@westat.com

Ephrata Cancer Center
Ephrata, Pennsylvania 17522
Contact:
Site Public Contact
717-721-4840

Adams Cancer Center
Gettysburg, Pennsylvania 17325
Contact:
Site Public Contact
877-441-7957

Cherry Tree Cancer Center
Hanover, Pennsylvania 17331
Contact:
Site Public Contact
877-441-7957

UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania 17109
Contact:
Site Public Contact
717-724-6765
klitchfield@PINNACLEHEALTH.org

Sechler Family Cancer Center
Lebanon, Pennsylvania 17042
Contact:
Site Public Contact
717-741-8303
doxenberg@wellspan.org

Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
Contact:
Site Public Contact
215-728-4790

University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-647-8073

UPMC Susquehanna
Williamsport, Pennsylvania 17701
Contact:
Site Public Contact
800-598-4282

WellSpan Health-York Cancer Center
York, Pennsylvania 17403
Contact:
Site Public Contact
877-441-7957

Medical University of South Carolina
Charleston, South Carolina 29425
Contact:
Site Public Contact
843-792-9321
hcc-clinical-trials@musc.edu

Prisma Health Cancer Institute - Easley
Easley, South Carolina 29640
Contact:
Site Public Contact
864-522-2066
kim.williams3@prismahealth.org

Prisma Health Cancer Institute - Butternut
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-522-2066
kim.williams3@prismahealth.org

Prisma Health Cancer Institute - Faris
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-522-2066
kim.williams3@prismahealth.org

Prisma Health Cancer Institute - Eastside
Greenville, South Carolina 29615
Contact:
Site Public Contact
864-522-2066
kim.williams3@prismahealth.org

Prisma Health Cancer Institute - Greer
Greer, South Carolina 29650
Contact:
Site Public Contact
864-522-2066
kim.williams3@prismahealth.org

Prisma Health Cancer Institute - Seneca
Seneca, South Carolina 29672
Contact:
Site Public Contact
864-522-2066
kim.williams3@prismahealth.org

Prisma Health Cancer Institute - Spartanburg
Spartanburg, South Carolina 29307
Contact:
Site Public Contact
864-522-2066
kim.williams3@prismahealth.org

Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
Contact:
Site Public Contact
605-312-3320
OncologyClinicTrialsSF@sanfordhealth.org

Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Contact:
Site Public Contact
605-312-3320
OncologyClinicalTrialsSF@SanfordHealth.org

The Don and Sybil Harrington Cancer Center
Amarillo, Texas 79106
Contact:
Site Public Contact
806-212-1985
gcravey@harringtoncc.org

Jefferson Healthcare
Port Townsend, Washington 98368
Contact:
Site Public Contact
360-344-3091

Edwards Comprehensive Cancer Center
Huntington, West Virginia 25701
Contact:
Site Public Contact
304-399-6617

Duluth Clinic Ashland
Ashland, Wisconsin 54806
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin 53105
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Health Care Germantown Health Center
Germantown, Wisconsin 53022
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Cancer Care-Grafton
Grafton, Wisconsin 53024
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin 53142
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
Contact:
Site Public Contact
608-775-2385
cancerctr@gundersenhealth.org

Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin 54143
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin 53051
Contact:
Site Public Contact
262-257-5100

Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin 53209
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin 53215
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Site Public Contact
414-805-3666

Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Cancer Care-Racine
Racine, Wisconsin 53406
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin 53081
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Medical Center in Summit
Summit, Wisconsin 53066
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin 54241
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin 53226
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora West Allis Medical Center
West Allis, Wisconsin 53227
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin 53095
Contact:
Site Public Contact
414-805-0505

Marshfield Clinic - Weston Center
Weston, Wisconsin 54476
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

More Details

NCT ID
NCT04268550
Status
Recruiting
Sponsor
Southwest Oncology Group

Detailed Description

PRIMARY OBJECTIVE: I. To evaluate the objective response rate (ORR) (confirmed complete or partial response) by blinded independent centralized review (BICR) associated with selpercatinib (LOXO-292) in patients with previously-treated stage IV or recurrent RET fusion-positive non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. To evaluate the duration of BICR-assessed response among BICR responders. II. To evaluate the frequency and severity of toxicities. III. To evaluate the investigator-assessed objective response rate (confirmed complete or partial response). IV. To evaluate duration of investigator-assessed response among patients with a response as determined by the local investigator. V. To evaluate investigator-assessed progression-free survival (IA-PFS). VI. To evaluate BICR-assessed PFS. VII. To evaluate overall survival (OS). VIII. Among patients with brain metastases at baseline: VIIIa. To evaluate the central nervous system (CNS) response rate (confirmed complete response [CR]). VIIIb. To evaluate the duration of intracranial response among patients with a CNS response. TRANSLATIONAL MEDICINE OBJECTIVES: 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 patients with refractory non-small cell lung cancer (NSCLC). OUTLINE: Patients receive selpercatinib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 2 years and then at the end of 3 years from date of sub-study registration.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.