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: 12 Mar 2026

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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

02 Mar 2026 Planned number of patients changed from 621 to 661.
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.

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