Recruiting
Phase 3

BNT327 & Chemotherapy

Sponsor:

BioNTech SE

Code:

NCT06712355

Conditions

Extensive-stage Small-cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pumitamig

Atezolizumab

Etoposide

Carboplatin (or cisplatin if carboplatin is not tolerated)

Study Details

Brief summary:

This is a Phase III, multisite, randomized, double-blinded study to investigate pumitamig (BNT327) combined with chemotherapy (etoposide/carboplatin) compared to atezolizumab combined with chemotherapy (etoposide/carboplatin) for the treatment of participants with previously untreated extensive-stage small-cell lung cancer (ES-SCLC).

Conditions

Extensive-stage Small-cell Lung Cancer

Study ID

NCT06712355

Start date

Feb 3, 2025

Status verified date

Aug, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Have histologically or cytologically confirmed ES-SCLC (using the AJCC \[American Joint Committee on Cancer\] tumor node metastasis staging system combined with Veterans Administration Lung Study Group \[VALG\]'s two stage classification scheme). For AJCC tumor node metastasis staging system: AJCC 8th edition stage IV (T any, N any, M1a/b/c), or T3\~4 for multiple lung nodules or tumor/nodule volume that cannot be encompassed in a tolerable radiotherapy plan.
  • Have not had prior systemic therapy for ES-SCLC. However, participants with prior chemoradiotherapy for limited-stage-SCLC must have been treated with curative intent and had a treatment-free interval of at least 6 months after the last chemotherapy, radiotherapy, or chemoradiotherapy before diagnosis of ES-SCLC to be eligible.
  • 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 (ECOG) performance status of 0 or 1.
  • Adequate hematologic and organ function as defined in the protocol.

Exclusion Criteria:

  • Have histologically or cytologically confirmed SCLC with combined histologies.
  • Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:

  • Within 2 weeks: small molecule agents with half-life of <7 days; radiation outside the thoracic cavity including whole brain radiation. Of note, other local radiation for brain lesions (not whole brain) is allowed; local radiation for bone lesions is allowed. Palliative bone radiation or brain stereotactic radiosurgery would not require a washout period, but participants should recover from radiotherapy-related toxicity.
  • Within 4 weeks: radiation involving the thoracic cavity; small molecule targeted agents with half-life of ≥7 days; monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies.
  • Have received prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or programmed death (ligand)-1 (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 the following central nervous system metastases:

  • Participants with untreated brain metastases that are symptomatic or large (e.g., greater than 2 cm).
  • Participants with treated central nervous system (CNS) metastases who are not neurologically stable or on steroids (at a dosage greater than 10 mg/Day of prednisone or an equivalent dose of other corticosteroid) within 7 days before initiating study treatment of this study.
  • Participants with known leptomeningeal metastases.
  • Have uncontrolled hypertension or poorly controlled diabetes prior to study treatment.
  • Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess for which an interval of 6 months must pass before study entry. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation.
  • Have a significant risk of hemorrhage (per investigator clinical judgment) as defined in the protocol.
  • Have superior vena cava syndrome or symptoms of spinal cord compression that requires urgent medical intervention.

NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Study Design

Enrollment

621 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Stage 1 Control Arm - Atezolizumab + Etoposide + Carboplatin

experimental: Stage 1 Treatment Arm 1 - Pumitamig Dose 1 + Etoposide + Carboplatin

experimental: Stage 1 Treatment Arm 2 - Pumitamig Dose 2 + Etoposide + Carboplatin

active comparator: Stage 2 Control Arm - Atezolizumab + Etoposide + Carboplatin

experimental: Stage 2 Treatment Arm - Pumitamig Dose 3 + Etoposide + Carboplatin

Interventions

Pumitamig

Intravenous infusion

Atezolizumab

Intravenous infusion

Etoposide

Intravenous infusion and capsules

Carboplatin (or cisplatin if carboplatin is not tolerated)

Intravenous infusion

Primary outcome measure

  • Overall survival (OS) [ Time Frame: Up to approximately 46 months ]

Central Contacts and Locations

Central contacts

BioNTech clinical trials patient information

+49 6131 9084patients@biontech.de

Locations

ACRC Arizona Clinical Research Center

Recruiting

Tucson, Arizona, United States, 85715

Cancer Care Centers of Brevard, Inc

Recruiting

Palm Bay, Florida, United States, 32901

Northside Hospital Atlanta

Recruiting

Atlanta, Georgia, United States, 30342

Illinois Cancer Specialists

Recruiting

Niles, Illinois, United States, 60714

Fort Wayne Medical Oncology and Hematology, Inc

Recruiting

Fort Wayne, Indiana, United States, 46804

McFarland Clinic

Recruiting

Ames, Iowa, United States, 50010

Helen G. Nassif Community Cancer Center

Recruiting

Cedar Rapids, Iowa, United States, 52403

Baptist Health Hardin Cancer Center

Recruiting

Elizabethtown, Kentucky, United States, 42701

LSU Health Baton Rouge - North Clinic

Recruiting

Baton Rouge, Louisiana, United States, 70805

Our Lady of the Lake Hospital, Inc.

Recruiting

Baton Rouge, Louisiana, United States, 70808

Frederick Health Hospital- James M Stockman Cancer Institute

Recruiting

Frederick, Maryland, United States, 21704

Beth Israel Lahey Health - Lahey Hospital & Medical Center (LHMC), Lahey Clinic Medical Center

Recruiting

Burlington, Massachusetts, United States, 01805

Baptist Cancer Center

Recruiting

Southaven, Mississippi, United States, 38671

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Nebraska Hematology-Oncology (NHO)

Recruiting

Lincoln, Nebraska, United States, 68506

Cornell University - NewYork-Presbyterian/Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10065

White Plains Hospital

Recruiting

White Plains, New York, United States, 10601

Cleveland Clinic - Akron General Hematology & Oncology

Recruiting

Akron, Ohio, United States, 44302

Cleveland Clinic Mercy Hospital Cancer Center

Recruiting

Canton, Ohio, United States, 44708

The Christ Hospital Cancer Center

Recruiting

Cincinnati, Ohio, United States, 45219

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

The Cleveland Clinic Cancer Center at Fairview Hospital, Moll Pavilion

Recruiting

Cleveland, Ohio, United States, 44111

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195-0001

Kettering Medical Center

Recruiting

Kettering, Ohio, United States, 45429

Cleveland Clinic - Hillcrest Hospital

Recruiting

Mayfield Heights, Ohio, United States, 44124

St. Luke's Physician Group - St. Luke's Cancer Care Associates

Recruiting

Fountain Hill, Pennsylvania, United States, 18015-1153

West Cancer Center & Research Institute

Recruiting

Germantown, Tennessee, United States, 38138

University of Tennessee Medical Center

Recruiting

Knoxville, Tennessee, United States, 37920

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Texas Oncology Cancer Center

Recruiting

Sugar Land, Texas, United States, 77479

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Hematology Oncology Associates of Fredericksburg, Inc.

Recruiting

Fredericksburg, Virginia, United States, 22408

Virginia Commonwealth University School of Medicine

Recruiting

Richmond, Virginia, United States, 23298

Shenandoah Oncology

Recruiting

Winchester, Virginia, United States, 22601

More Information

Sponsor

BioNTech SE

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • First-line ES-SCLC
  • SCLC
  • Immunotherapy in combination with chemotherapy
  • Untreated
  • Bispecific antibody
  • Programmed death-ligand 1 (PD-L1)
  • Vascular endothelial growth factor (VEGF) A
  • Immunotherapy
  • Combination with other investigational agents
  • Pumitamig
  • BNT327
  • Check point inhibitor
  • Lung cancer
  • Etoposide
  • Carboplatin
  • Cisplatin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BioNTech SE on 2026-09-01.