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Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer

NCT06712316 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1260

Last updated 2026-05-22

No results posted yet for this study

Summary

This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC).

This study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice for standard-of-care and type of NSCLC.

Conditions

Interventions

DRUG

Pumitamig

Intravenous infusion

DRUG

Pembrolizumab

Intravenous infusion

DRUG

Carboplatin

Intravenous infusion

DRUG

Pemetrexed

Intravenous infusion

DRUG

Paclitaxel

Intravenous infusion

Sponsors & Collaborators

Principal Investigators

  • BioNTech Responsible Person · BioNTech SE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-07
Primary Completion
2029-02-28
Completion
2030-03-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • China
  • France
  • Georgia
  • Germany
  • Italy
  • Japan
  • Poland
  • Romania
  • South Korea
  • Spain
  • Switzerland
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT06712316 on ClinicalTrials.gov