Clinical Trial

A Global Pivotal Study in Participants with KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in those with PD-L1 expression >= 50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum regardless of PD-L1 Expression (J3M-MC-JZQB)

MOA: LY3537982 is an orally bioavailable small molecule inhibitor of the KRASG12C protein

Key Eligibility Criteria:

• Locally advanced or metastatic (Stage IIIB-IIIC or Stage IV) NSCLC
• Previously untreated, not suitable for curative intent surgery
• Prior neoadj/adjuvant or consolidation therapy will be allowed provided treatment was completed 6 months prior to study entry
• 1 cycle of SOC prior to study enrollment will be allowed for cases where immediate therapy is clinically indicated, as follows:
  • Part A: single cycle of pembrolizumab pembrolizumab, or pembrolizumab monotherapy
  • Part B: single cycle of either pemetrexed-platinum with or without
• KRASG12C mutation and PD-L1 expression determined in tumor tissue or blood (local testing) are required
• No known targetable mutation or alteration in genes such as EGFR, ALK, BRAF (V600E), HER2, MET (exon 14), ROS1, RET, or NTRK1/2/3 (testing is not required).
• No active CNS metastases and/or carcinomatous meningitis