A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer

Conditions

• Carcinoma, Non-Small-Cell Lung
• Neoplasm Metastasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• LY3537982 — DRUG
  Administered orally.
• Pembrolizumab — DRUG
  Administered IV.
• Placebo — DRUG
  Administered orally.
• Cisplatin — DRUG
  Administered IV.
• Carboplatin — DRUG
  Administered IV.
• Pemetrexed — DRUG
  Administered IV.

Study Details

The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.

Key Dates

Start date

Dec 21, 2023

Status verified

Jun 2026

Primary completion

Nov 30, 2027

Completion

Jan 31, 2031

Study Design

Enrollment

1,264 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dose Optimization: LY3537982 Dose Level 1 plus Pembrolizumab
  LY3537982 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.
• Experimental: Dose Optimization: LY3537982 Dose Level 2 plus Pembrolizumab
  LY3537982 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.
• Experimental: Safety Lead In: LY3537982 plus Pembrolizumab, Pemetrexed and Platinum
  LY3537982 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.
• Experimental: Part A: LY3537982 plus Pembrolizumab
  LY3537982 administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
• Placebo Comparator: Part A: Placebo plus Pembrolizumab
  Placebo administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
• Experimental: Part B: LY3537982 plus Pembrolizumab, Pemetrexed, and Platinum
  LY3537982 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.
• Placebo Comparator: Part B: Placebo plus Pembrolizumab, Pemetrexed, and Platinum
  Placebo 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.
• Experimental: Part C: LY3537982 plus Pembrolizumab
  LY3537982 administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

Primary Outcome Measure

Dose Optimization and Safety Lead-In Part B: Number of Participants with a Treatment Emergent Adverse Event(s) (TEAE) [ Time Frame: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year) ]

Central Contacts

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  1-317-615-4559
  [email protected]
• Physicians interested in becoming principal investigators please contact
  [email protected]

Locations (91)

Find similar trials in Huntsville, AL

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