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Olomorasib

DRUG9 trials

Sponsors

Eli Lilly & Co., Eli Lilly and Company, Janssen Research & Development, LLC, UNC Lineberger Comprehensive Cancer Center

Conditions

Carcinoma, Non-Small-Cell LungColorectal NeoplasmsHealthyHepatic InsufficiencyKRAS G12C-Mutant Advanced Solid TumorsLocally Advanced NSCLCLung CancerLung Cancer (NSCLC)

Phase 1

LOXO-RAS-20001; A Phase 1a/1b Study of LY3537982 in Patients with KRAS G12C-Mutant Advanced Solid Tumors
RecruitingCTIS2022-502756-31-00
Eli Lilly & Co.KRAS G12C-Mutant Advanced Solid Tumors
Start: 2022-07-20Target: 200Updated: 2026-01-23
A Study of Olomorasib (LY3537982) in Participants With Hepatic Impairment and Healthy Participants
CompletedNCT06719128
Eli Lilly and CompanyHealthy, Hepatic Insufficiency
Start: 2024-12-06End: 2025-08-25Updated: 2025-09-22
A Study of Multiple Olomorasib (LY3537982) Capsules in Healthy Participants
CompletedNCT07044271
Eli Lilly and CompanyHealthy
Start: 2025-07-11End: 2025-11-08Updated: 2026-05-29
A Study of Olomorasib (LY3537982) in Healthy Japanese Participants
CompletedNCT07124013
Eli Lilly and CompanyHealthy
Start: 2025-09-16End: 2026-01-05Updated: 2026-01-16
A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer
RecruitingNCT07227025
Janssen Research & Development, LLCCarcinoma, Non-Small-Cell Lung
Start: 2026-03-03End: 2029-04-30Target: 60Updated: 2026-08-28
A Study of Olomorasib (LY3537982) in Healthy Participants
CompletedNCT07439250
Eli Lilly and CompanyHealthy
Start: 2026-03-02End: 2026-04-17Updated: 2026-05-19

Phase 2

Olomorasib + Pembrolizumab KRAS G12C Mutant, PD-L1 TPS 1-49% Locally Advanced or Metastatic NSCLC
SuspendedNCT07639242
UNC Lineberger Comprehensive Cancer CenterLocally Advanced NSCLC, Lung Cancer, Lung Cancer (NSCLC) +1
Start: 2026-10-01End: 2030-06-21Target: 60Updated: 2026-08-28
A Study of Olomorasib (LY3537982) in Participants With Advanced Colorectal Cancer and a KRAS G12C Mutation
Not yet recruitingNCT07814417
Eli Lilly and CompanyColorectal Neoplasms
Start: 2026-10-01End: 2028-11-01Target: 50Updated: 2026-09-11

Phase 3

Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer
RecruitingNCT06890598
Eli Lilly and CompanyCarcinoma, Non-Small-Cell Lung
Start: 2025-03-27End: 2032-02-01Target: 700Updated: 2026-09-08

Related Papers

First-line (1L) olomorasib + pembrolizumab in patients with <i>KRAS</i> G12C–mutant advanced NSCLC, and PD-L1 expression 0-49%, from the dose optimization cohorts of LOXO-RAS-20001 and SUNRAY-01.
Journal of Clinical Oncology2026-05-28