A Phase 2, Randomized, Open-label, Study Assessing the Safety, Tolerability and Efficacy of Imzokitug in Combination with Pumitamig and Platinum-Doublet Chemotherapy (PDCT) versus Pumitamig and PDCT as First-line Treatment for Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2026-525170-19-00

Enrollment

Registered

2026-09-07

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Brief summary

Main endpoint is the Objective Response Rate (ORR) assessed by the Investigator (the study doctor).

Detailed description

Endpoints include incidence of all adverse events (AEs), including AEs leading to discontinuation, and death (per CTCAE v5.0) and additional anti-tumor efficacy parameters, such as PFS, DOR, and TTR as assessed by the Investigator and OS. Doctors will measure the size of the tumors using special rules called RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1.

Interventions

DRUGEntyvio 300 mg powder for concentrate for solution for infusion

DRUGBNT327 20 mg ml

DRUGPACLITAXEL

DRUGBNT327 50 mg ml

DRUGCARBOPLATIN

DRUGINFLIXIMAB

DRUGCISPLATIN

DRUGPEMETREXED

DRUGAnti-CCR8 NF mAb

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Main endpoint is the Objective Response Rate (ORR) assessed by the Investigator (the study doctor).	—

Secondary

Measure	Time frame
Endpoints include incidence of all adverse events (AEs), including AEs leading to discontinuation, and death (per CTCAE v5.0) and additional anti-tumor efficacy parameters, such as PFS, DOR, and TTR as assessed by the Investigator and OS. Doctors will measure the size of the tumors using special rules called RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 8, 2026