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OncoMatch/Clinical Trials/NCT06841055

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

Is NCT06841055 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pumitamig and Docetaxel for non-small cell lung cancer.

Phase 2RecruitingBioNTech SENCT06841055Data as of May 2026

Treatment: Pumitamig · DocetaxelThis 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.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: PD-L1 (CD274) historical PD-L1 results must be available

Historical PD-L1 results must be available.

Disease stage

Required: Stage IV

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 1 prior line
Min 1 prior line

Must have received: anti-PD-1 therapy — first-line advanced/metastatic

programmed death-1 [PD-1]/ programmed death ligand-1 [PD-L1] inhibitor and platinum-based chemotherapy concomitantly

Must have received: platinum-based chemotherapy — first-line advanced/metastatic

programmed death-1 [PD-1]/ programmed death ligand-1 [PD-L1] inhibitor and platinum-based chemotherapy concomitantly

Cannot have received: anti-VEGF monoclonal antibody

prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody

Cannot have received: anti-PD-(L)-1/aVEGF bispecific antibody

anti-PD-(L)-1/aVEGF bispecific antibody

Cannot have received: docetaxel

docetaxel as monotherapy or in combination with other agents

Lab requirements

Blood counts

Adequate organ function as defined in the protocol.

Kidney function

Adequate organ function as defined in the protocol.

Liver function

Adequate organ function as defined in the protocol.

Adequate organ function as defined in the protocol.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • The University of Alabama at Birmingham Hospital · Birmingham, Alabama
  • Moffitt Cancer Center · Tampa, Florida
  • Baptist Health Hardin · Elizabethtown, Kentucky
  • NYU Langone - NYU Grossman School of Medicine · New York, New York
  • Texas Oncology, P.A. · Houston, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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