A Phase 1b/2, Open-label, Randomized Study of Vudalimab in Combination With Chemotherapy or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced Non-small Cell Lung Cancer

Vudalimab + carboplatin/pemetrexed versus Pembrolizumab + carboplatin/pemetrexed

• Histologically confirmed, locally advanced (unresectable) or metastatic nonsquamous NSCLC
• Documented absence of tumor activating epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK) gene and c-ros oncogene 1 (ROS1) rearrangements. Patients with unknown or indeterminate EGFR, ALK, or ROS1 status are excluded
  *Documented absence of alterations in any other actionable driver oncogenes for which there are locally approved targeted first-line therapies, based on testing conducted as part of standard local practice
• PD-L1 IHC testing documenting TPS < 1% or between 1% and 49%
• No prior systemic treatment for advanced/metastatic NSCLC. Prior adjuvant, neoadjuvant, or chemoradiation/consolidation therapy is permitted, provided treatment was completed ≥ 12 months prior to development of metastatic disease
• Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  *Adequate archival formalin-fixed paraffin-embedded (FFPE) tumor block(s)/slides
• ECOG performance status score of 0 or 1

• Active known or suspected autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus or residual hypothyroidism due to an autoimmune condition that is treatable with hormone replacement therapy only; autoimmune adrenal insufficiency that is managed with low-dose corticosteroids;
• Have known active central nervous system metastases and/or carcinomatous meningitis. Patients with treated brain metastases may participate, provided they are radiologically stable (ie, are without evidence of progression for ≥ 4 weeks by repeat imaging performed during the screening period, are clinically stable, and are without requirement of steroid treatment for ≥ 7 days prior to the first dose of study treatment)