RATIONALE-305 | BGB-A317-305

TislelizumabGC/GEJCPhase 3Completed

Summary

This study was designed to compare the efficacy and safety of tislelizumab plus chemotherapy versus placebo plus chemotherapy as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Study ArmPopulationInterventionComparisonOutcome

Previously untreated advanced/metastatic GC/GEJC


Tislelizumab

+ Investigator-chosen chemotherapy


Placebo

+ Investigator-chosen chemotherapy


Primary Endpoint: OS in PD-L1+ (PD-L1 score ≥5%) and ITT population


Key Secondary Endpoints: PFS, ORR, DoR, DCR, CBR, HRQoL, safety


Phase III RATIONALE trial design comparing the efficacy & safety of tislelizumab + chemotherapy vs placebo + chemotherapy as first-line treatment for GEJ cancer

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