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

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NCT06712316 · readout ≤ 896 d

Sponsored by BioNTech SE (industry) · BNTX — their whole pipeline →. With Bristol-Myers Squibb.

Phase

Phase 2/3

Status

Recruiting

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

1,580estimated

Sites

261

Countries

Australia, Belgium, Brazil +17

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

2025-01-07

actual

When the study began enrolling

Primary completion

Jan 2029

estimated

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

Study completion

Dec 2031

estimated

The whole study's end, after follow-up

First posted

2024-12-02

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-08-13

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: Pumitamig — also filed as BNT327, BMS-986545, PM8002
Drug: Pembrolizumab
Drug: Carboplatin
Drug: Pemetrexed
Drug: Paclitaxel

Primary outcomes

what the primary-completion date above is the date OF

Phase 2 - Occurrence of treatment-emergent adverse events (TEAE) (including Grade ≥3), adverse events of special interest (AESIs), treatment-related TEAEs, treatment-emergent serious adverse events (SAE), and treatment-related treatment emergent SAEs

measured From the first dose of the investigational medicinal product (IMP) to the 90-day Follow-Up Visit

Phase 2 - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs)

measured From the first dose of IMP to the 90-day Follow-Up Visit

Phase 2 - Objective response rate (ORR)

measured Up to approximately 2 years

Phase 2 - Best percentage change from baseline in tumor size

measured Up to approximately 2 years

Phase 3 - Progression free survival (PFS) assessed by BICR

measured Up to approximately 5 years

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