Recruiting
Phase 2

BNT327 & Chemotherapy

Sponsor:

BioNTech SE

Code:

NCT06841055

Conditions

Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pumitamig

Docetaxel

Study Details

Brief summary:

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.

Conditions

Non-small Cell Lung Cancer

Study ID

NCT06841055

Start date

Mar 3, 2025

Status verified date

Apr, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Have histologically or cytologically confirmed diagnosis of Stage IV NSCLC that has documented radiographic progression on one or after one prior line of systemic treatment (programmed death-1 \[PD-1\]/ programmed death ligand-1 \[PD-L1\] inhibitor and platinum-based chemotherapy concomitantly) in advanced/metastatic setting per the American Joint Committee on Cancer staging system, 9th edition.

  • Participants must have received minimum two cycles of immunotherapy in first-line treatment to be eligible to this study.
  • Only one prior line of immunotherapy containing regimen is allowed in an advanced/metastatic setting. If participant had received adjuvant immunotherapy the disease-free interval (after the last dose of adjuvant immunotherapy) should be at least 6 months.
  • Historical PD-L1 results must be available.
  • Participants with actionable genetic alterations may be enrolled if they received locally approved and available targeted agent in combination with immunotherapy in first-line advanced/metastatic setting.
  • Enrollment of participants with primary resistance (best response being radiological progression to prior immunochemotherapy) will be kept below 30% in the overall study population.
  • Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been documented after irradiation. Historical images within 28 days of the screening visit may be accepted as a screening image if deemed acceptable in the opinion of the investigator.
  • Participants must provide tumor tissue samples obtained ≤18 months prior to enrollment. For the additional cohort in Part 2, both baseline (freshly obtained) and on-treatment tumor biopsy samples are required.
  • Eastern cooperative oncology group performance status of 0 or 1.
  • Adequate organ function as defined in the protocol.

Key Exclusion Criteria:

  • Have a known or suspected hypersensitivity to the study treatments, their metabolites or formulation of excipients including polysorbate 80 (see Docetaxel label).
  • Participants who received prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or anti-PD-(L)-1/aVEGF bispecific antibody or docetaxel as monotherapy or in combination with other agents.
  • Have received more than one prior lines of therapies in advanced/metastatic setting.
  • Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment (except for docetaxel premedication). Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed.
  • Participants who have received prior radiotherapy may be enrolled if they have no acute toxicity related to this therapy.
  • Have uncontrolled hypertension or poorly controlled diabetic conditions within 7 days prior to the first dose of study treatment.
  • Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra abdominal abscess or esophageal and gastric varices, or acute gastrointestinal bleeding. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation.
  • Participants with significant risk of hemorrhage as defined in the protocol.
  • Have superior vena cava syndrome or symptoms of spinal cord compression.

NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1A - Pumitamig Dose 1 + docetaxel

experimental: Part 1B - Pumitamig Dose 2 + docetaxel

experimental: Part 2: Selected doses of pumitamig + docetaxel

Pumitamig and docetaxel will be administered at the dose level recommended by an internal review committee based on the observed safety profile from Part 1.

Interventions

Pumitamig

Intravenous infusion

Docetaxel

Intravenous infusion

Primary outcome measure

  • Part 1 - Occurrence of dose limiting toxicities (DLTs) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From initiation of the first dose of IMP until the 90-day Safety Follow-up visit ]
  • Part 1 and Part 2 - Objective response rate [ Time Frame: Up to approximately 2 years ]

Central Contacts and Locations

Central contacts

BioNTech clinical trials patient information

+49 6131 9084patients@biontech.de

Locations

The University of Alabama at Birmingham Hospital

Recruiting

Birmingham, Alabama, United States, 35249

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Baptist Health Hardin

Recruiting

Elizabethtown, Kentucky, United States, 42701

NYU Langone - NYU Grossman School of Medicine

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

BioNTech SE

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

  • Second-line treatment
  • Immunotherapy
  • Combination with other investigational agents
  • Bispecific antibody
  • Vascular endothelial growth factor (VEGF) A
  • Programmed death-ligand 1 (PD-L1)
  • Combination with chemotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by BioNTech SE on 2026-04-24.