RATIONALE-312 | BGB-A317-312

TislelizumabES-SCLCPhase 3Completed

Summary

This Phase 3 study was a randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the efficacy of tislelizumab in combination with either cisplatin or carboplatin and etoposide (Arm A), compared to placebo combined with either cisplatin or carboplatin and etoposide (Arm B), as a first-line treatment for participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC).

Study ArmPopulationInterventionComparisonOutcome

Previously untreated ES-SCLC


Tislelizumab + Chemotherapy


Placebo + Chemotherapy


Primary Endpoint: OS (ITT population)


Key Secondary Endpoints: PFS (INV), ORR, DoR, DCR, HRQoL


Phase III RATIONALE trial design comparing tislelizumab + chemo vs placebo + chemo in previously untreated ES-SCLC

You are now leaving the website

This link is provided for information purposes only. You’ll be leaving beonemedaffairs.com and accessing a third-party website over which [BeOne Medicines | GmbH] has no control or influence.

This link will take you to a third-party website outside of beonemedaffairs.com.

[BeOne Medicines | GmbH] has no control over this website and makes no representations regarding its content or availability in your location. [BeOne Medicines | GmbH] declines any responsibility for third-party information, data usage policies, or personal data processing.

By proceeding, you acknowledge that you are part of the intended audience of the third-party website and confirm your compliance with applicable laws.

Do you want to leave beonemedaffairs.com

You are now leaving the the website beonemedaffairs.com and entering another BeOne website with different terms of use. Information included on this website may not be specific to your country. Click Continue to proceed