Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer

Conditions

• Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Olomorasib — DRUG
  Administered orally.
• Pembrolizumab — DRUG
  Administered intravenously (IV).
• Durvalumab — DRUG
  Administered IV.
• Placebo — DRUG
  Administered orally.

Study Details

The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant.

Key Dates

Start date

Mar 27, 2025

Status verified

Jun 2026

Primary completion

May 31, 2029

Completion

Feb 29, 2032

Study Design

Enrollment

700 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part A: Olomorasib + Pembrolizumab
  Participants will receive olomorasib administered orally in combination with pembrolizumab intravenously (IV) for up to 1 year followed by olomorasib alone for up to 3 years of total treatment.
• Placebo Comparator: Part A: Placebo + Pembrolizumab
  Participants will receive placebo administered orally in combination with pembrolizumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment.
• Experimental: Part B: Olomorasib + Durvalumab
  Participants will receive olomorasib administered orally in combination with durvalumab administered IV for up to 1 year followed by olomorasib alone for up to 3 years of total treatment.
• Placebo Comparator: Part B: Placebo + Durvalumab
  Participants will receive placebo administered orally in combination with durvalumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment.

Primary Outcome Measure

Part A: Disease-Free Survival (DFS) by Investigator Assessment [ Time Frame: Randomization to disease recurrence or death from any cause (Estimated as approximately 48 months). ]

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 (85)

Find similar trials in Huntsville, AL

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