Clinical Trial

An Interventional Phase 3, Double-Blind, Randomized Study to Evaluate Efficacy and Safety of PF-08634404 in Combination With Chemotherapy Versus Pembrolizumab in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

MOA: F-08634404 is a PD-1xVEGF bispecific antibody.

Key Eligibility Criteria:

• LA (Stage IIIB/C) or met (Stage IV) squamous or non-squamous NSCLC not eligible for curative surgery and/or chemoradiotherapy
• PD-L1 status available based on local SoC testing results
• Measurable disease by RECIST v1.1
• Participants with known AGAs with available front-line tx are excluded
  • Pts with non-squamous NSCLC must have documented negative results for EGFR, ALK, and ROS1 AGAs
• Known active CNS or leptomeningeal metastases are excluded
• Pts with clinically significant risk of hemorrhage or fistula are excluded
• Prior systemic anti-tumor therapy, including anti-PD-(L)1 tx for LA/met NSCLC are excluded
  • (Neo)adjuvant anti-PD-(L)1 allowed if PD occurred ≥9 months after the last dose
  • Other (neo)adjuvant or definitive therapy is allowed if PD occurred ≥6 months after the last dose.