RATIONALE-304 | BGB-A317-304

TislelizumabNSCLCPhase 3Completed

Summary

This study evaluated the efficacy and safety of tislelizumab in combination with platinum (cisplatin or carboplatin) and pemetrexed compared with platinum and pemetrexed alone as first-line treatment in participants with Stage IIIB or IV non-squamous non-small cell lung cancer (NSCLC).

Study ArmPopulationInterventionComparisonOutcome

Previously untreated advanced non-squamous NSCLC


Tislelizumab + Platinum + Pemetrexed


Platinum + Pemetrexed


Primary Endpoint: PFS (IRC)


Key Secondary Endpoints: OS, ORR, DoR, safety, QoL


Phase III RATIONALE trial design comparing efficacy & safety of tislelizumab + platinum + pemetrexed vs platinum + pemetrexed in NSCLC

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