NCT07111520

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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Part 1 is a dose escalation to evaluate and establish two or three safe combination dose levels (DL1 and DL2 and optionally DL3) of BNT326 with BNT327. Part 2a is a dose expansion to evaluate the preliminary efficacy, safety, and tolerability. Part 2b is a dose optimization and contribution of components part. Parts 1 and 2a (Cohort A) will enroll participants with previous exposure to therapy for advanced/metastatic disease. Part 2a (Cohort B) and Part 2b (Cohorts C and D) will enroll less heavily pre-treated participants, namely those without prior systemic treatment for advanced/metastatic disease. The sponsor, having heard the internal review committee, may determine the dose levels for each arm in Cohorts C and D based on data generated from Parts 1 and 2a. The dose levels chosen for Cohorts C and D will not exceed the highest dose level investigated in this study. Parts 1 and 2a will be non-randomized. In Part 2b, participants will be randomized to different treatments within each cohort. The study consists of a screening period, a treatment period, a safety follow-up period, an efficacy follow-up period, and a long-term survival follow-up. Participants will receive study treatment until disease progression, withdrawal of consent, termination of the study by the sponsor, unacceptable toxicity, or for a maximum duration of 24 months (or for the maximum duration as per the local product label for participants receiving standard of care \[SoC\] therapy), whichever occurs first. For each study participant, the treatment and follow-up periods are projected to be completed within \~36 months, unless participants are continuing to benefit from treatment per investigator's recommendation and upon sponsor approval.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	BNT326	intravenous (IV) infusion
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.

Timeline

• Start date: 2025-09-22
• Primary completion: 2029-01-01
• Completion: 2030-01-01
• First posted: 2025-08-08
• Last updated: 2025-10-22

Locations

2 sites across 2 countries: United States, Moldova

Regulatory

• FDA-regulated drug study