Trial Profile

A Phase III, Multisite, Double-blinded Randomized Trial of BNT327 in Combination With Chemotherapy (Etoposide/Carboplatin) Compared to Atezolizumab in Combination With Chemotherapy (Etoposide/Carboplatin) in Participants With First-line Extensive-stage Small-cell Lung Cancer

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 10 Dec 2025

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At a glance

Drugs Carboplatin (Primary) ; Etoposide (Primary) ; Pumitamig (Primary) ; Atezolizumab
Indications Small cell lung cancer
Focus Registrational; Therapeutic Use
Acronyms ROSETTA Lung-01
Sponsors BioNTech

26 Nov 2025 Protocol has been amended(Time frame of the primary efficacy endpoint, planned patient number).
26 Nov 2025 Planned number of patients changed from 439 to 621.
26 Nov 2025 Planned End Date changed from 1 Sep 2028 to 1 Mar 2029.

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