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LY3537982

Phase 3

Carcinoma, Non-Small-Cell Lung | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Jun 3, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment1,804
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06119581A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung CancerPHASE3 RECRUITING 1,264 — — Dec 21, 2023Jan 1, 2031Jun 3, 2026422 United States, Australia +27
NCT04956640Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)PHASE1 ACTIVE NOT_RECRUITING 540 — — Jul 19, 2021Apr 1, 2027May 29, 202649 United States, Australia +4
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Study Endpoints
Primary Endpoints
Dose Optimization and Safety Lead-In Part B: Number of Participants with a Treatment Emergent Adverse Event(s) (TEAE)
Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)

Dose Optimization and Safety Lead-In Part B: Number of Participants with a TEAE

Part A and Part B: Progression-Free Survival (PFS)
Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)

PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR)

Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY3537982 monotherapy
Cycle 1 (21 Days)

Measured by the number of patients with dose-limiting toxicities (DLTs)

Phase 1b: To assess the safety and tolerability of LY3537982 when administered alone or in combination with other investigational agents
Cycle 1 (21 Days)

Measured by the number of patients with dose-limiting toxicities (DLTs)

Phase 1b: To determine the optimal dose of LY3537982 to be administered to treatment-naïve participants with advanced NSCLC in combination with pembrolizumab
Estimated up to 2 years

Measured by TEAEs

To determine the optimal dose of LY3537982 to be administered to participants who have received at least one prior oxaliplatin- or irinotecan-containing regimen for advanced or metastatic CRC in combination with cetuximab
Estimated up to 2 years
To assess the antitumor activity of LY3537982 monotherapy in participants with advanced pancreatic cancer with KRAS G12C mutation
Estimated up to 2 years
Secondary Endpoints
Part A and Part B: Overall Survival (OS)
Randomization to date of death from any cause. (Estimated as up to 3 years)
Part A and Part B: PFS
Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Part A and Part B: Overall Response Rate (ORR): Percentage of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)
Randomization to disease progression or death. (Estimated as approximately 1 year)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose Optimization: LY3537982 Dose Level 1 plus PembrolizumabEXPERIMENTALLY3537982 Dose level 1 administered orally in combination with pembrolizumab administered intravenously (IV) in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
Dose Optimization: LY3537982 Dose Level 2 plus PembrolizumabEXPERIMENTALLY3537982 Dose level 2 administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
Safety Lead In: LY3537982 plus Pembrolizumab, Pemetrexed and PlatinumEXPERIMENTALLY3537982 administered orally in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
Part A: LY3537982 plus PembrolizumabEXPERIMENTALLY3537982 administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
Part A: Placebo plus PembrolizumabPLACEBO_COMPARATORPlacebo administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
Part B: LY3537982 plus Pembrolizumab, Pemetrexed, and PlatinumEXPERIMENTALLY3537982 administered orally in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
Part B: Placebo plus Pembrolizumab, Pemetrexed, and PlatinumPLACEBO_COMPARATORPlacebo administered orally in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
Part C: LY3537982 plus PembrolizumabEXPERIMENTALLY3537982 administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
LY3537982 (Dose Escalation)EXPERIMENTALLY3537982 administered orally.
LY3537982 (Dose Expansion)EXPERIMENTALLY3537982 administered orally either alone or with another investigational agent.
LY3537982 (Dose Optimization)EXPERIMENTALLY3537982 administered orally either alone or with another investigational agent
Interventions
NameTypeDescription
LY3537982DRUGAdministered orally.
PembrolizumabDRUGAdministered IV.
PlaceboDRUGAdministered orally.
CisplatinDRUGAdministered IV.
CarboplatinDRUGAdministered IV.
PemetrexedDRUGAdministered IV.
CetuximabDRUGIntravenous
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites422

Inclusion Criteria: * Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy. * Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with peme...

Countries:United StatesAustraliaAustriaBelgiumBrazilCanadaChinaCzechiaDenmarkFranceGermanyGreeceHungaryIndiaItalyJapanMexicoNetherlandsNorwayPolandPortugalRomaniaSouth KoreaSpainSwedenSwitzerlandTaiwanTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)
LOWJun 3, 2026NCT06119581lastUpdatePostDate: changed
LOWJun 3, 2026NCT06119581lastUpdatePostDate: changed
MEDIUMMay 29, 2026NCT04956640Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMMay 29, 2026NCT04956640Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 26, 2026NCT04956640primaryCompletionDate: changed
LOWMay 26, 2026NCT06119581primaryCompletionDate: changed
LOWMay 24, 2026NCT04956640studyFirstPostDate: changed
LOWMay 24, 2026NCT06119581studyFirstPostDate: changed