Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line Treatment

NCT06841055 · readout ≤ 803 d

Sponsored by BioNTech SE (industry) · BNTX — their whole pipeline →. With BioNTech (Shanghai) Pharmaceuticals Co., Ltd..

Phase

Phase 2

Status

Recruiting

Study type

Interventional

Design

Non randomized · None · Treatment

Enrollment

60estimated

Sites

Countries

Australia, South Korea, Spain +3

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

2025-03-03

actual

When the study began enrolling

Primary completion

Oct 2028

estimated

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

Study completion

Oct 2028

estimated

The whole study's end, after follow-up

First posted

2025-02-24

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-04-24

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, PM8002, BMS-986545
Drug: Docetaxel

Primary outcomes

what the primary-completion date above is the date OF

Part 1 - Occurrence of dose limiting toxicities (DLTs)

measured Up to 21 days after first dose of investigational medicinal product (IMP)

Part 1 and Part 2 - Occurrence of pumitamig treatment emergent adverse events, treatment-related adverse events, treatment emergent serious adverse events, treatment-related serious adverse events, and adverse events of special interest

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

Part 1 and Part 2 - Occurrence of dose interruption, dose reduction, and/or participant discontinuation due to adverse events

measured From initiation of the first dose of IMP until the 90-day Safety Follow-up visit

Part 1 and Part 2 - Objective response rate

measured Up to approximately 2 years

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