RecruitingPhase 1Phase 2NCT07111520

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)

A Phase Ib/II, Multi-site, Open-label, Dose Finding Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT326 in Combination With BNT327 in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)


Sponsor

BioNTech SE

Enrollment

420 participants

Start Date

Sep 22, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination treatment using BNT326 and BNT323 — two antibody-drug conjugates that deliver chemotherapy directly to cancer cells — for people with advanced non-small cell lung cancer (NSCLC). Different combinations and patient groups are being studied across multiple treatment parts. **You may be eligible if...** - You are 18 years or older with advanced (metastatic or locally recurrent) non-small cell lung cancer that cannot be treated with curative intent - You have measurable disease on imaging - Your physical condition is good (ECOG 0-1) - Your organ function meets required levels - Tumor tissue is available for testing - Depending on the cohort: you may need to have progressed on prior therapy, or have specific genetic markers **You may NOT be eligible if...** - You have active brain metastases requiring treatment - You have had prior treatment with the specific drugs being tested - You have significant heart, lung, or autoimmune conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBNT326

intravenous (IV) infusion

DRUGBNT327

IV infusion

DRUGPembrolizumab

IV infusion

DRUGSoC

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


Locations(2)

NEXT Virginia

Fairfax, Virginia, United States

Institute of Oncology, ARENSIA Exploratory Medicine

Chisinau, Moldova

View Full Details on ClinicalTrials.gov

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NCT07111520


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