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Clinical Trials in the USA / NCT04956640
Active, not recruiting Phase 1/2

Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)

NCT04956640 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 1/2
Started
2021-07-19
Last updated
2026-05-29

Condition(s) studied

Carcinoma, Non-Small-Cell LungColorectal NeoplasmsEndometrial NeoplasmsOvarian NeoplasmsPancreatic NeoplasmsBiliary Tract Neoplasms

Investigational drug(s) / intervention(s)

LY3537982PembrolizumabCetuximabPemetrexedCisplatinCarboplatin

LY3537982: Oral

Pembrolizumab: Intravenous

Cetuximab: Intravenous

Pemetrexed: Intravenous

Cisplatin: Intravenous

Carboplatin: Intravenous

Study summary

The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must have already received or were not able to tolerate the standard of care, except for specific groups who have not had cancer treatment. The study will last up to approximately 4 years.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Patients have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). * Patients must have disease with evidence of KRAS G12C mutation in tumor tissue or circulating tumor deoxyribonucleic acid (DNA). * Participants must have a histological or a cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer and meet cohort-specific criteria. * Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Have adequate organ function. * Have discontinued all previous treatments for cancer with resolution of any significant ongoing adverse events (AEs), (except in certain scenarios). * Must be able to swallow capsule/tablet. * Agree and adhere to contraceptive use, if applicable. * For some parts of the study, (i.e., one of the two arms with LY3537982 in combination with pembrolizumab and the arm of LY3537982 in combination with pembrolizumab, pemetrexed, and platinum therapy) histologically or cytologically confirmed Stage IIIB-IIIC or Stage IV NSCLC that is previously untreated in the advanced/metastatic setting and not suitable for curative intent radical surgery or radiation therapy. Previously untreated patients who received adjuvant and neoadjuvant therapy are eligible if the last dose of the systemic treatment was completed at least 6 months prior to enrollment. For untreated patients in the arm with LY3537982 in combination with pembrolizumab noted above, a single cycle of pembrolizumab may be initiated within 21 days prior to enrollment. For untreated patients in the arm of LY3537982 in combination with pembrolizumab, pemetrexed, and platinum therapy, a single cycle of any or all of the drugs other than LY3537982 may be initiated within 21 days prior to enrollment. Start of study treatment may be delayed to allow sufficient time for recovery from treatment-related toxicity. * For one part of the study, participants must have received at least one prior oxaliplatin- or irinotecan-containing regimen for advanced or metastatic CRC. Exclusion Criteria: * Disease suitable for local therapy administered with curative intent. * Have an active, ongoing, or untreated infection. * Have a serious pre-existing medical condition(s) that, in the judgment of the investigator, would preclude participation in this study. * Have a serious cardiac condition. * Have a second active primary malignancy or have been diagnosed and/or treated for an additional malignancy within 3 years prior to enrollment. * For some parts of the study only: have untreated active central nervous system (CNS) metastases and/or leptomeningeal disease. Patients with treated CNS metastases are eligible for this study if their disease is asymptomatic, radiographically stable for at least 30 days, and they do not require treatment with steroids in the two-week period prior to study treatment. Patients with active CNS metastases are eligible for one part of the study. * Have received prior treatment with any KRAS G12C small molecule inhibitor, except in certain scenarios where such prior therapy is allowed as per protocol. * The following patients will be excluded from some parts of the study: * Experienced certain serious side effects with prior immunotherapy. * Have an active autoimmune disease that has required systemic anti-autoimmune treatment in the past 2 years. * Have received a live vaccine within 30 days prior to the first dose of study drug. * Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 35 days after the last dose of study medication. * Known allergic reaction against any of the components of the study treatments.

Primary outcome measure(s)

Trial sites (49)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
USC Norris Cancer Hospital Los Angeles California
Chao Family Comprehensive Cancer Ctr. Orange California
Yale-New Haven Hospital New Haven Connecticut
AdventHealth Orlando Orlando Florida
Florida Cancer Specialists Sarasota Florida
Indiana Univ Melvin & Bren Simon Cancer Center Indianapolis Indiana
Community Health Network Indianapolis Indiana
Mary Bird Perkins Cancer Center Baton Rouge Louisiana
Massachusetts General Hospital Boston Massachusetts
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
NYU Langone Health- Long Island Mineola New York
NYU Langone New York New York
Memorial Sloan Kettering Cancer Center New York New York
The University of North Carolina at Chapel Hill Chapel Hill North Carolina
Novant Health Cancer Institute - Elizabeth Charlotte North Carolina
Novant Health Cancer Institute - Forsyth Winston-Salem North Carolina
Fox Chase Cancer Center Philadelphia Pennsylvania
UPMC Hillman Cancer Center Pittsburgh Pennsylvania
Sarah Cannon Cancer Center Nashville Tennessee
Vanderbilt Univeristy School of Medicine Nashville Tennessee
South Texas Accelerated Research Therapeutics (START) San Antonio Texas
START Mountain Region West Valley City Utah
Inova Health System IRB Fairfax Virginia
USO-Virginia Cancer Specialists, PC Fairfax Virginia
University of Wisconsin-Madison Hospital and Health Clinic Madison Wisconsin
Royal North Shore Hospital St Leonards New South Wales
St Vincent's Hospital Sydney Sydney New South Wales
Cancer Research SA Adelaide South Australia
Peninsula and Southeast Oncology Frankston Victoria
Linear Clinical Research Nedlands Western Australia
Cross Cancer Institute Edmonton Alberta
Princess Margaret Hospital (Ontario) Toronto Ontario
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest Bordeaux Aquitaine
Centre Leon Berard Lyon Auvergne-Rhône-Alpes
Institut du Cancer de Montpellier - Val d'aurelle Montpellier France
Institut Claudius Regaud - IUCT Oncopole Toulouse France
Gustave Roussy Villejuif France
Aichi Cancer Center Hospital Nagoya Aichi-ken
National Cancer Center Hospital East Kashiwa Chiba

+ 9 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04956640 on ClinicalTrials.gov ↗ ← All trials in the USA