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
Intervention
Vudalimab + carboplatin/pemetrexed versus Pembrolizumab + carboplatin/pemetrexed
Key outcome parameters
Key inclusion criteria
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
Key exclusion criteria
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)
