Phase 1b Study of Dato-DXd in Combination with Immunotherapy with or without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer - TROPION-Lung04

Inclusion Criteria

• - Participant ≥18 years old on the day of signing the ICF (local regulatory requirement to consent should be followed).
• - Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC, without EGFR or ALK genomic alterations and no known genomic alterations in other actionable driver kinases with approved therapies
• - For Cohorts 1 to 4, participants must be treatment-naïve or have received and radiologically progressed after only 1 prior line of systemic chemotherapy, without concomitant immune checkpoint inhibitors for advanced or metastatic NSCLC. For Cohorts 5 to 11, participants must be treatment-naïve for advanced or metastatic NSCLC.
• - Willing and able to undergo a mandatory tumor biopsy
• - Has measurable disease per RECIST1.1 within 28 days prior to Cycle 1 Day 1
• - Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1 at screening
• - Has adequate bone marrow reserve and organ function at baseline within 7 days prior to Cycle 1 day 1
• - For Cohorts 5 to 11 only: Documented IHC PD-L1 expression per analytically validated Ventana PD-L1 (SP263) IHC assay, 22C3 PharmDx assay, or 28-8 PharmDx assay