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Clinical Trials in the EU / 2026-525170-19-00
Authorised, recruiting Phase II

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)

2026-525170-19-00 · tracked via the Priya Life Science EU tracker
Sponsor type
Pharmaceutical company
Therapeutic area
Neoplasms
Decision date
07/09/2026
Enrollment target
77
Sites
Italy, Spain, Romania, Germany, France

Condition studied

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

Investigational medicinal product(s)

BNT327 50 mg mlEntyvio 300 mg powder for concentrate for solution for infusionCISPLATINPEMETREXEDINFLIXIMABAnti-CCR8 NF mAbBNT327 20 mg mlCARBOPLATINPACLITAXEL

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

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

Endpoint detail

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.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2026-525170-19-00 on CTIS ↗ ← All trials in the EU