RATIONALE-303 | BGB-A317-303

TislelizumabNSCLCPhase 3Completed

Summary

The purpose of this study is to show that tislelizumab will improve overall survival in participants with Stage IIIB or IV non-small cell lung cancer when compared to docetaxel in second or third-line treatment settings.

Detailed Description

This is a randomized, open-label, multicenter Phase 3 study in adult participants with histologically confirmed, locally advanced or metastatic (Stage IIIB or IV), NSCLC (squamous or non-squamous) who have disease progression during or after a platinum-containing regimen.

Study ArmPopulationInterventionComparisonOutcome

Previously treated (post-platinum) advanced/metastatic NSCLC


Tislelizumab


Docetaxel


Primary Endpoint: OS in ITT and PD-L1 ≥25% populations


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


Phase III RATIONALE trial design comparing the survival rate of lung cancer patients taking tislelizumab vs docetaxel in second or third-line treatment

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