Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT04956640

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

Led by Eli Lilly and Company · Updated on 2025-09-25

540

Participants Needed

49

Research Sites

297 weeks

Total Duration

On this page

Sponsors

E

Eli Lilly and Company

Lead Sponsor

M

Merck Sharp & Dohme LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients have measurable disease according to RECIST v1.1 criteria.
  • Disease must show evidence of KRAS G12C mutation in tumor tissue or circulating tumor DNA.
  • Diagnosis of locally advanced, unresectable, or metastatic cancer confirmed by histology or cytology.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Adequate organ function as determined by screening tests.
  • Discontinued all prior cancer treatments with resolution of significant ongoing side effects, except in specified scenarios.
  • Ability to swallow capsules or tablets.
  • Agree to use contraception if applicable.
  • For some study parts, untreated Stage IIIB-IIIC or IV non-small-cell lung cancer not suitable for curative surgery or radiation, with specific prior treatment conditions.
  • For one study arm, prior treatment with at least one oxaliplatin- or irinotecan-containing regimen for advanced or metastatic colorectal cancer required.
Not Eligible

You will not qualify if you...

  • Disease suitable for local therapy with curative intent.
  • Active, ongoing, or untreated infections.
  • Serious pre-existing medical conditions that may prevent participation.
  • Serious cardiac conditions.
  • Second active primary cancer or cancer diagnosed/treated within 3 years before enrollment.
  • Untreated active central nervous system metastases or leptomeningeal disease for some study parts; treated CNS metastases allowed if stable and asymptomatic.
  • Prior treatment with any KRAS G12C small molecule inhibitor except as allowed by protocol.
  • Certain serious side effects from prior immunotherapy for some study parts.
  • Active autoimmune disease requiring systemic treatment in past 2 years.
  • Received live vaccine within 30 days before first study drug dose.
  • Pregnant, breastfeeding, or planning pregnancy through 35 days after last dose.
  • Known allergy to any study treatment components.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 49 locations

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

USC Norris Cancer Hospital

Los Angeles, California, United States, 90033

Actively Recruiting

3

Chao Family Comprehensive Cancer Ctr.

Orange, California, United States, 92868

Actively Recruiting

4

Yale-New Haven Hospital

New Haven, Connecticut, United States, 06510

Actively Recruiting

5

AdventHealth Orlando

Orlando, Florida, United States, 32803

Actively Recruiting

6

Florida Cancer Specialists

Sarasota, Florida, United States, 34236

Actively Recruiting

7

Indiana Univ Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, United States, 46202

Actively Recruiting

8

Community Health Network

Indianapolis, Indiana, United States, 46250

Actively Recruiting

9

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States, 70809

Actively Recruiting

10

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

11

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

Actively Recruiting

12

NYU Langone Health- Long Island

Mineola, New York, United States, 11501

Actively Recruiting

13

NYU Langone

New York, New York, United States, 10016

Actively Recruiting

14

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

15

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

16

Novant Health Cancer Institute - Elizabeth

Charlotte, North Carolina, United States, 28204

Actively Recruiting

17

Novant Health Cancer Institute - Forsyth

Winston-Salem, North Carolina, United States, 27103

Actively Recruiting

18

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111-2497

Actively Recruiting

19

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

20

Sarah Cannon Cancer Center

Nashville, Tennessee, United States, 37203

Actively Recruiting

21

Vanderbilt Univeristy School of Medicine

Nashville, Tennessee, United States, 37212-6303

Actively Recruiting

22

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, United States, 78229-3307

Actively Recruiting

23

START Mountain Region

West Valley City, Utah, United States, 84119

Actively Recruiting

24

Inova Health System IRB

Fairfax, Virginia, United States, 22031

Actively Recruiting

25

USO-Virginia Cancer Specialists, PC

Fairfax, Virginia, United States, 22031

Actively Recruiting

26

University of Wisconsin-Madison Hospital and Health Clinic

Madison, Wisconsin, United States, 53792-4108

Actively Recruiting

27

Royal North Shore Hospital

St Leonards, New South Wales, Australia, 2065

Actively Recruiting

28

St Vincent's Hospital Sydney

Sydney, New South Wales, Australia, 2010

Actively Recruiting

29

Cancer Research SA

Adelaide, South Australia, Australia, 5000

Actively Recruiting

30

Peninsula and Southeast Oncology

Frankston, Victoria, Australia, 3199

Actively Recruiting

31

Linear Clinical Research

Nedlands, Western Australia, Australia, 6009

Actively Recruiting

32

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

Actively Recruiting

33

Princess Margaret Hospital (Ontario)

Toronto, Ontario, Canada, M4X 1K9

Actively Recruiting

34

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

Bordeaux, Aquitaine, France, 33076

Actively Recruiting

35

Centre Leon Berard

Lyon, Auvergne-Rhône-Alpes, France, 69008

Actively Recruiting

36

Institut du Cancer de Montpellier - Val d'aurelle

Montpellier, France, 34298

Actively Recruiting

37

Institut Claudius Regaud - IUCT Oncopole

Toulouse, France, 31052

Actively Recruiting

38

Gustave Roussy

Villejuif, France, 94805

Actively Recruiting

39

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan, 464-8681

Actively Recruiting

40

National Cancer Center Hospital East

Kashiwa, Chiba, Japan, 277-8577

Actively Recruiting

41

Hokkaido University Hospital

Sapporo, Hokkaido, Japan, 060-8648

Actively Recruiting

42

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan, 920

Actively Recruiting

43

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan, 104-0045

Actively Recruiting

44

Wakayama Medical University Hospital

Wakayama, Japan, 641-8510

Actively Recruiting

45

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea, 10408

Actively Recruiting

46

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

Suwon, Gyeonggi-do, South Korea, 16247

Actively Recruiting

47

Chonnam National University Hwasun Hospital

Hwasun-gun, Jeonranamdo, South Korea, 58128

Actively Recruiting

48

Seoul National University Hospital

Seoul, Korea, South Korea, 03080

Actively Recruiting

49

Asan Medical Center

Seoul, Korea, South Korea, 05505

Actively Recruiting

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Research Team

T

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

P

Physicians interested in becoming principal investigators please contact

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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