Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)
NCT ID: NCT04956640
Last Updated: 2025-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
540 participants
INTERVENTIONAL
2021-07-19
2027-04-30
Brief Summary
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Detailed Description
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This study will be conducted in 4 parts: Phase 1a dose escalation, Phase 1b dose expansion, Phase 1b dose optimization, and Phase 2. KRAS G12C mutations will be identified through standard of care testing.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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LY3537982 (Dose Escalation)
LY3537982 administered orally.
LY3537982
Oral
LY3537982 (Dose Expansion)
LY3537982 administered orally either alone or with another investigational agent.
LY3537982
Oral
Pembrolizumab
Intravenous
Cetuximab
Intravenous
Pemetrexed
Intravenous
Cisplatin
Intravenous
Carboplatin
Intravenous
LY3537982 (Dose Optimization)
LY3537982 administered orally either alone or with another investigational agent
LY3537982
Oral
Pembrolizumab
Intravenous
Cetuximab
Intravenous
Interventions
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LY3537982
Oral
Pembrolizumab
Intravenous
Cetuximab
Intravenous
Pemetrexed
Intravenous
Cisplatin
Intravenous
Carboplatin
Intravenous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Related Links
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Study of LY3537982 in Cancer Patients with a Specific Genetic Mutation (KRAS G12C)
Other Identifiers
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2021-000595-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
J3M-OX-JZQA
Identifier Type: OTHER
Identifier Source: secondary_id
MK-3475-E27/KEYNOTE E27
Identifier Type: OTHER
Identifier Source: secondary_id
2022-502756-31-00
Identifier Type: CTIS
Identifier Source: secondary_id
LOXO-RAS-20001
Identifier Type: -
Identifier Source: org_study_id
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