RATIONALE-307 | BGB-A317-307

TislelizumabNSCLCPhase 3Completed

Summary

An open-label, randomized, multicenter Phase 3 study designed to compare the efficacy and safety of tislelizumab combined with chemotherapy versus chemotherapy only as first-line treatment in advanced squamous non-small cell lung cancer (NSCLC).

Study ArmPopulationInterventionComparisonOutcome

Previously untreated advanced squamous NSCLC


Tislelizumab + Paclitaxel + Carboplatin


Tislelizumab + Nab-paclitaxel + Carboplatin


Paclitaxel + Carboplatin


Primary Endpoint: PFS (IRC)


Key Secondary Endpoints: ORR, DoR, OS, Safety


Phase III RATIONALE trial design comparing efficacy & safety of tislelizumab + chemo vs only chemo in squamous NSCLC

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