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Non-small Cell Lung CancerCancerLungs and breathingDrugPhase 2

What this study is

This is a Phase II, multisite, open-label study consisting of two parts in participants with advanced/metastatic Non-small Cell Lung Cancer (NSCLC) which progressed after a first-line chemoimmunotherapy to evaluate the combination of pumitamig (also known as BNT327, BMS-986545 or PM8002) with standard of care.

Part 1 is a safety run-in with pumitamig (Dose 1 or Dose 2) plus docetaxel and will include up to 12 participants in total to be treated in Part 1A and 1B sequentially.

Part 2 is a dose expansion at the deemed safe dose of pumitamig plus docetaxel and will include up to 54 participants.

What's being tested

  • Pumitamig

    Intervention · DRUG

  • Docetaxel

    Intervention · DRUG

Both interventions

Intravenous infusion

Study details

Official title
A Phase II, Multisite, Open-label Trial of Pumitamig (BNT327) in Combination With Standard-of-care Chemotherapy in First-line and Second-line Non-small Cell Lung Cancer (NSCLC)
Sponsor
BioNTech SE
Conditions
Non-small Cell Lung Cancer
Enrolling
60 people
Starts
2025-03-03
Est. completion
2028-10
Design
Open-label, non-randomized, sequential groups, Phase 2
Record
View on ClinicalTrials.gov ↗