RATIONALE-315 | BGB-A317-315

TislelizumabNSCLCPhase 3Active, not recruiting

Summary

The primary objective of this study is to evaluate and compare major pathological response (MPR) rate and event-free survival (EFS) in participants receiving tislelizumab plus platinum-based doublet chemotherapy as the new additional treatment followed by tislelizumab as adjuvant treatment versus participants receiving placebo plus platinum-based doublet chemotherapy as neoadjuvant treatment followed by placebo as adjuvant treatment.

Study ArmPopulationInterventionComparisonOutcome

Resectable Stage II/ IIIA NSCLC


Tislelizumab + Platinum-based doublet chemotherapy


Placebo + Platinum-based doublet chemotherapy


Primary Endpoint: MPR and EFS (by BICR) in ITT population


Key Secondary Endpoints: OS, pCR, ORR, DFS, INV-assessed EFS, HRQoL, safety


Phase III RATIONALE trial design comparing tislelizumab + chemo vs placebo + chemo as neoadjuvant/adjuvant therapy in NSCLC

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