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NCT06712355Phase 3RECRUITING

Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer

Study Summary

This is a Phase III, multisite, randomized, double-blinded study to investigate pumitamig (BNT327) combined with chemotherapy (etoposide/carboplatin) compared to atezolizumab combined with chemotherapy (etoposide/carboplatin) for the treatment of participants with previously untreated extensive-stage small-cell lung cancer (ES-SCLC).

Conditions
Extensive-stage Small-cell Lung Cancer
Interventions / Drugs
PumitamigAtezolizumabEtoposideCarboplatin (or cisplatin if carboplatin is not tolerated)
View on ClinicalTrials.gov ↗
Sponsor
BNTX
BioNTech SE
mRNA Therapeutics
F20/100
Study Details
Enrollment621 participants
Primary Completion—
Lead SponsorBioNTech SE
Data Retrieved2026-04-11 02:55:25.057564+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 621 participants
Sponsor Catalyst Profile

BioNTech SE (BNTX) is the sponsoring company for this trial. BiotechSign currently grades this company F (20/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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