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New pill targets hard-to-treat cancers with KRAS mutation

NCT ID NCT04956640

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called LY3537982 in people with advanced solid tumors that have a specific KRAS G12C mutation. The goal is to see if the drug is safe and shrinks tumors. About 540 participants with lung, colorectal, endometrial, ovarian, pancreatic, or bile duct cancers will take the drug alone or with other treatments. The study lasts up to 4 years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 540 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2021

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

biliary tract cancer biliary tract neoplasm Biliary Tract Neoplasms colorectal cancer colorectal neoplasm endometrial cancer endometrium neoplasm malignant pancreatic neoplasm non-small cell lung carcinoma ovarian cancer ovarian neoplasm pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary tract neoplasms Carcinoma, non-small-cell lung Colorectal neoplasms Endometrial neoplasms Ovarian neoplasms Pancreatic neoplasms

Contacts and locations

Locations

  • AdventHealth Orlando

    Orlando, Florida, 32803, United States

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681, Japan

  • Asan Medical Center

    Seoul, Korea, 05505, South Korea

  • Cancer Research SA

    Adelaide, South Australia, 5000, Australia

  • Centre Leon Berard

    Lyon, Auvergne-Rhône-Alpes, 69008, France

  • Chao Family Comprehensive Cancer Ctr.

    Orange, California, 92868, United States

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, Jeonranamdo, 58128, South Korea

  • Community Health Network

    Indianapolis, Indiana, 46250, United States

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Florida Cancer Specialists

    Sarasota, Florida, 34236, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2497, United States

  • Gustave Roussy

    Villejuif, 94805, France

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648, Japan

  • Indiana Univ Melvin & Bren Simon Cancer Center

    Indianapolis, Indiana, 46202, United States

  • Inova Health System IRB

    Fairfax, Virginia, 22031, United States

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

    Bordeaux, Aquitaine, 33076, France

  • Institut Claudius Regaud - IUCT Oncopole

    Toulouse, 31052, France

  • Institut du Cancer de Montpellier - Val d'aurelle

    Montpellier, 34298, France

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920, Japan

  • Linear Clinical Research

    Nedlands, Western Australia, 6009, Australia

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • NYU Langone

    New York, New York, 10016, United States

  • NYU Langone Health- Long Island

    Mineola, New York, 11501, United States

  • National Cancer Center

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

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577, Japan

  • Novant Health Cancer Institute - Elizabeth

    Charlotte, North Carolina, 28204, United States

  • Novant Health Cancer Institute - Forsyth

    Winston-Salem, North Carolina, 27103, United States

  • Peninsula and Southeast Oncology

    Frankston, Victoria, 3199, Australia

  • Princess Margaret Hospital (Ontario)

    Toronto, Ontario, M4X 1K9, Canada

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065, Australia

  • START Mountain Region

    West Valley City, Utah, 84119, United States

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203, United States

  • Seoul National University Hospital

    Seoul, Korea, 03080, South Korea

  • South Texas Accelerated Research Therapeutics (START)

    San Antonio, Texas, 78229-3307, United States

  • St Vincent's Hospital Sydney

    Sydney, New South Wales, 2010, Australia

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

    Suwon, Gyeonggi-do, 16247, South Korea

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • USC Norris Cancer Hospital

    Los Angeles, California, 90033, United States

  • USO-Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of Wisconsin-Madison Hospital and Health Clinic

    Madison, Wisconsin, 53792-4108, United States

  • Vanderbilt Univeristy School of Medicine

    Nashville, Tennessee, 37212-6303, United States

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8510, Japan

  • Yale-New Haven Hospital

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.