Clinical Trial

A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naive Subjects with Advanced or Metastatic PD-L1 High (TPS>=50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung08)(Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects with Advanced or Metastatic NSCLC Without Actionable Genomic Alterations)(DS1062-A-U304)

Brief Summary: This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC) of non-squamous histology.

Key Eligibility Criteria:

• Histologically documented Stage IIIB/IIIC NSCLC not candidates for surgical resection/definitive chemoradiation, or Stage IV NSCLC disease
• Documented negative test results for EGFR/ALK/ROS1 actionable genomic alterations
• No known actionable genomic alterations in NTRK/BRAF/RET/MET/other actionable driver kinases
• Tumor has high PD-L1 expression (TPS ≥50%)
• Received prior systemic treatment for advanced/metastatic NSCLC excluded
• Received prior treatment in any of adjuvant/neoadjuvant setting excluded