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)

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NCT07111520 · readout ≤ 834 d

Sponsored by BioNTech SE (industry) · BNTX — their whole pipeline →. With MediLink Therapeutics (Suzhou) Co., Ltd..

Phase

Phase 1/2

Status

Recruiting

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

880estimated

Sites

Countries

Australia, China, Germany +7

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2025-09-22

actual

When the study began enrolling

Primary completion

Nov 2028

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

Jun 2030

estimated

The whole study's end, after follow-up

First posted

2025-08-08

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-08-05

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Non-small Cell Lung Cancer

Interventions

Drug: BNT326
Drug: Pumitamig — also filed as BNT327, PM8002

Primary outcomes

what the primary-completion date above is the date OF

Part 1 - Occurrence of dose limiting toxicities (DLTs) within a participant

measured 21 days starting on Day 1 of Cycle 1

Part 1 and Part 2a - Occurrence of treatment emergent adverse events (TEAEs), treatment-related adverse events (TRAE), treatment emergent serious adverse events (TESAE), treatment-related serious adverse events (TRSAE)

measured from the first dose of investigational medicinal product (IMP) up to 90 days after the last dose of IMP or until a new systemic anti-cancer therapy is started, whichever occurs first (up to a maximum of 27 months)

Part 1 and Part 2a - Occurrence of dose interruption, reduction, and discontinuation due to TEAEs

measured from the first dose of IMP up to 90 days after the last dose of IMP or until a new systemic anti-cancer therapy is started, whichever occurs first (up to a maximum of 27 months)

Part 2a and Part 2b - Objective response rate (ORR)

measured from the time of initiation of the first dose of IMP to approximately 36 months

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