Recruiting
Phase 2
Phase 3

BNT327, Chemotherapy, Investigational Agents

Sponsor:

BioNTech SE

Code:

NCT06712316

Conditions

Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pumitamig

Pembrolizumab

Carboplatin

Pemetrexed

Paclitaxel

Study Details

Brief summary:

This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC).

This study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice for standard-of-care and type of NSCLC.

Conditions

Non-small Cell Lung Cancer

Study ID

NCT06712316

Start date

Jan 7, 2025

Status verified date

Sep, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Have systemic treatment naive, histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system, 9th edition.
  • Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion).
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1.
  • Adequate organ function as defined in the protocol.

Key Exclusion Criteria:

  • Have histologically or cytologically confirmed NSCLC with small-cell lung cancer or neuroendocrine histologic component.
  • Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:

  • Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in either neoadjuvant/adjuvant or locally advanced/metastatic setting.
  • Participants who received prior treatment with anti-VEGF monoclonal antibody, or PD(L)-1/VEGF bispecific antibody.
  • 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. 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.
  • Have uncontrolled hypertension or poorly controlled diabetic conditions prior to 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. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing fistula/perforation.
  • Participants with significant risk of hemorrhage (per investigator clinical judgment).
  • Participants have superior vena cava syndrome or symptoms of spinal cord compression.

NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Study Design

Enrollment

1580 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Substudy A Phase 2 (Arm 1) - Pumitamig Dose 1 + Carboplatin + Pemetrexed

experimental: Substudy A Phase 2 (Arm 2) - Pumitamig Dose 2 + Carboplatin + Pemetrexed

experimental: Substudy A Phase 2 (Arm 1A - China only) - Pumitamig Dose 3 + Carboplatin + Pemetrexed

experimental: Substudy A Phase 3 (Arm 3) - Pumitamig Dose 3 + Carboplatin + Pemetrexed

active comparator: Substudy A Phase 3 (Arm 4) - Pembrolizumab + Carboplatin + Pemetrexed

experimental: Substudy B Phase 2 (Arm 1) - Pumitamig Dose 1 + Carboplatin + Paclitaxel

experimental: Substudy B Phase 2 (Arm 2) - Pumitamig Dose 2 + Carboplatin + Paclitaxel

experimental: Substudy B Phase 2 (Arm 1A, China only) - Pumitamig Dose 3 + Carboplatin + Paclitaxel

experimental: Substudy B Phase 3 (Arm 3) - Pumitamig Dose 3 + Carboplatin + Paclitaxel

active comparator: Substudy B Phase 3 (Arm 4) - Pembrolizumab + Carboplatin + Paclitaxel

Interventions

Pumitamig

Intravenous infusion

Pembrolizumab

Intravenous infusion

Carboplatin

Intravenous infusion

Pemetrexed

Intravenous infusion

Paclitaxel

Intravenous infusion

Primary outcome measure

  • Phase 2 - Occurrence of treatment-emergent adverse events (TEAE) (including Grade ≥3), adverse events of special interest (AESIs), treatment-related TEAEs, treatment-emergent serious adverse events (SAE), and treatment-related treatment emergent SAEs [ Time Frame: From the first dose of the investigational medicinal product (IMP) to the 90-day Follow-Up Visit ]
  • Phase 2 - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs) [ Time Frame: From the first dose of IMP to the 90-day Follow-Up Visit ]
  • Phase 2 - Objective response rate (ORR) [ Time Frame: Up to approximately 2 years ]
  • Phase 2 - Best percentage change from baseline in tumor size [ Time Frame: Up to approximately 2 years ]
  • Phase 3 - Progression free survival (PFS) assessed by BICR [ Time Frame: Up to approximately 5 years ]

Central Contacts and Locations

Central contacts

BioNTech clinical trials patient information

+49 6131 9084patients@biontech.de

Locations

Birmingham Hematology and Oncology Associates LLC d/b/a Alabama Oncology

Recruiting

Birmingham, Alabama, United States, 35223

Alaska Oncology and Hematology, LLC

Recruiting

Anchorage, Alaska, United States, 99508

John Muir Clinical Research Center

Recruiting

Concord, California, United States, 94520

University Of California - San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Clermont Oncology Center

Recruiting

Clermont, Florida, United States, 34711

Mid Florida Cancer Centers

Recruiting

Orange City, Florida, United States, 32763

Cleveland Clinic Florida - Martin North Hospital

Recruiting

Stuart, Florida, United States, 34994

H. Lee Moffit Cancer center and research institute

Recruiting

Tampa, Florida, United States, 33612

Cleveland Clinic Weston Hospital

Recruiting

Weston, Florida, United States, 33331

Fort Wayne Medical Oncology and Hematology, Inc.

Recruiting

Fort Wayne, Indiana, United States, 46845

Physicians Clinic of Iowa

Recruiting

Cedar Rapids, Iowa, United States, 52401-2112

Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Baptist Health Hardin

Recruiting

Elizabethtown, Kentucky, United States, 42701

Frederick Health Hospital- James M Stockman Cancer Institute

Recruiting

Frederick, Maryland, United States, 21704

Missouri Cancer Associates

Recruiting

Columbia, Missouri, United States, 65201

SSM Health Cancer Care - St. Clare

Recruiting

Fenton, Missouri, United States, 63026

Mary Lanning Healthcare (MLH) - Morrison Cancer Center (MCC)

Recruiting

Hastings, Nebraska, United States, 68901-4470

Astera Cancer Care

Recruiting

East Brunswick, New Jersey, United States, 08816

Summit Medical Group PA

Recruiting

Florham Park, New Jersey, United States, 07932

The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion

Recruiting

Paramus, New Jersey, United States, 07652

Suny-Stony Brook University Cancer Center

Recruiting

Stony Brook, New York, United States, 11794-9446

White Plains Hospital

Recruiting

White Plains, New York, United States, 10601

Fletcher Hospital, Inc. dba AdventHealth Hendersonville

Recruiting

Hendersonville, North Carolina, United States, 28792

Gabrail Cancer Center Research

Recruiting

Canton, Ohio, United States, 44718

The Christ Hospital Cancer Center

Recruiting

Cincinnati, Ohio, United States, 45219

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

The Cleveland Clinic Cancer Center At Fairview Hospital, Moll Pavilion

Recruiting

Cleveland, Ohio, United States, 44111

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195-0001

Dayton Physicians Network

Recruiting

Dayton, Ohio, United States, 45415

Kettering Medical Center

Recruiting

Kettering, Ohio, United States, 45429

Cleveland Clinic - Hillcrest Hospital

Recruiting

Mayfield Heights, Ohio, United States, 44124

INTEGRIS Cancer Institute of Oklahoma

Recruiting

Oklahoma City, Oklahoma, United States, 73109

University of Tennessee Medical Center

Recruiting

Knoxville, Tennessee, United States, 37920

Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Virginia Cancer Specialists - Arlington

Recruiting

Arlington, Virginia, United States, 22201

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

VCU Massey Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Shenandoah Oncology

Recruiting

Winchester, Virginia, United States, 22601

More Information

Sponsor

BioNTech SE

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • First-line treatment
  • Combination with chemotherapy
  • Combination with other investigational agents
  • Bispecific antibody
  • Programmed death-ligand 1 (PD-L1)
  • Vascular endothelial growth factor (VEGF) A
  • Immunotherapy
  • Programmed Death-1 monoclonal antibodies
  • Pumitamig
  • Lung cancer
  • BNT327
  • Carboplatin
  • Pemetrexed
  • Paclitaxel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by BioNTech SE on 2026-09-04.