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

NCT06712355 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 621

Last updated 2026-02-13

No results posted yet for this 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

DRUG

Pumitamig

Intravenous infusion

DRUG

Atezolizumab

Intravenous infusion

DRUG

Etoposide

Intravenous infusion and capsules

DRUG

Carboplatin (or cisplatin if carboplatin is not tolerated)

Intravenous infusion

Sponsors & Collaborators

Principal Investigators

  • BioNTech Responsible Person · BioNTech SE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-03
Primary Completion
2028-12-31
Completion
2029-03-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • Germany
  • Japan
  • Poland
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06712355 on ClinicalTrials.gov