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A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)

NCT07111520 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2026-05-05

No results posted yet for this study

Summary

This is a multi-site, open-label, dose-finding study, consisting of Parts 1, 2a, and 2b to investigate the combination of BNT326 with BNT327 in participants with relapsed, progressive as well as treatment-naïve, advanced/metastatic non-small cell lung cancer (NSCLC).

This study will enroll adult participants with histologically or cytologically confirmed NSCLC that is advanced (i.e., either metastatic or recurrent tumors with no known curative treatment available).

Conditions

Interventions

DRUG

BNT327

IV infusion

DRUG

Pembrolizumab

IV infusion

DRUG

SoC

IV infusion. Combination chemotherapy (pemetrexed, paclitaxel, or carboplatin). Chemotherapy will be selected according to the indication.

DRUG

BNT326

intravenous (IV) infusion

Sponsors & Collaborators

  • MediLink Therapeutics (Suzhou) Co., Ltd.

    collaborator INDUSTRY

  • BioNTech SE

    lead INDUSTRY

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
2025-09-22
Primary Completion
2029-01-31
Completion
2030-01-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • Germany
  • Italy
  • Moldova
  • Poland
  • Spain
  • 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 NCT07111520 on ClinicalTrials.gov