RecruitingPhase 1Phase 2NCT04956640

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

A Phase 1/2 Study of LY3537982 in Patients With KRAS G12C-Mutant Advanced Solid Tumors

Sponsor

Eli Lilly and Company

Enrollment

540 participants

Start Date

Jul 19, 2021

Study Type

INTERVENTIONAL

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new targeted drug called LY3537982 (adagrasib-class KRAS G12C inhibitor) in people with advanced cancers that have a specific genetic mutation called KRAS G12C. This mutation is found in some lung, colon, and other cancers, and this drug is designed to block the faulty protein it produces. The drug can be used alone or in combination with immunotherapy and chemotherapy. **You may be eligible if...** - You are 18 or older with advanced or metastatic cancer confirmed by biopsy - Your tumor has the KRAS G12C mutation (found in a tissue or blood test) - You have measurable disease on scans - You are in good health (ECOG 0–1) - Your organ function is adequate - (For some parts) You have advanced lung cancer that has not yet been treated, or colorectal cancer that has progressed on prior treatment **You may NOT be eligible if...** - Your cancer can still be treated with surgery or radiation with the goal of cure - You have an active infection, serious heart condition, or other major health problem - You have had another cancer within 3 years - You have already received a KRAS G12C inhibitor (with some exceptions) - You have received a live vaccine in the past 30 days - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLY3537982

Oral

DRUGPembrolizumab

Intravenous

DRUGCetuximab

Intravenous

DRUGPemetrexed

Intravenous

DRUGCisplatin

Intravenous

DRUGCarboplatin

Intravenous

Locations(49)

University of Alabama at Birmingham

Birmingham, Alabama, United States

USC Norris Cancer Hospital

Los Angeles, California, United States

Chao Family Comprehensive Cancer Ctr.

Orange, California, United States

Yale-New Haven Hospital

New Haven, Connecticut, United States

AdventHealth Orlando

Orlando, Florida, United States

Florida Cancer Specialists

Sarasota, Florida, United States

Indiana Univ Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, United States

Community Health Network

Indianapolis, Indiana, United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

NYU Langone Health- Long Island

Mineola, New York, United States

NYU Langone

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Novant Health Cancer Institute - Elizabeth

Charlotte, North Carolina, United States

Novant Health Cancer Institute - Forsyth

Winston-Salem, North Carolina, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Sarah Cannon Cancer Center

Nashville, Tennessee, United States

Vanderbilt Univeristy School of Medicine

Nashville, Tennessee, United States

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, United States

START Mountain Region

West Valley City, Utah, United States

Inova Health System IRB

Fairfax, Virginia, United States

USO-Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

University of Wisconsin-Madison Hospital and Health Clinic

Madison, Wisconsin, United States

Royal North Shore Hospital

St Leonards, New South Wales, Australia

St Vincent's Hospital Sydney

Sydney, New South Wales, Australia

Cancer Research SA

Adelaide, South Australia, Australia

Peninsula and Southeast Oncology

Frankston, Victoria, Australia

Linear Clinical Research

Nedlands, Western Australia, Australia

Cross Cancer Institute

Edmonton, Alberta, Canada

Princess Margaret Hospital (Ontario)

Toronto, Ontario, Canada

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

Bordeaux, Aquitaine, France

Centre Leon Berard

Lyon, Auvergne-Rhône-Alpes, France

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, Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Wakayama Medical University Hospital

Wakayama, Japan

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

The Catholic University of Korea, St. Vincent's Hospital

Suwon, Gyeonggi-do, South Korea

Chonnam National University Hwasun Hospital

Hwasun-gun, Jeonranamdo, South Korea

Seoul National University Hospital

Seoul, Korea, South Korea

Asan Medical Center

Seoul, Korea, South Korea

View Full Details on ClinicalTrials.gov

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NCT04956640