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Clinical Trials in the UK / NCT06712355
Recruiting Phase 3

Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer

NCT06712355 · tracked via the Priya Life Science UK tracker
Sponsor
BioNTech SE
Phase
Phase 3
Started
2025-02-03
Last updated
2026-09-01

Condition(s) studied

Extensive-stage Small-cell Lung Cancer

Investigational drug(s) / intervention(s)

PumitamigAtezolizumabEtoposideCarboplatin (or cisplatin if carboplatin is not tolerated)

Pumitamig: Intravenous infusion

Atezolizumab: Intravenous infusion

Etoposide: Intravenous infusion and capsules

Carboplatin (or cisplatin if carboplatin is not tolerated): Intravenous infusion

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (225)

FacilityCityRegionStatus
ACRC Arizona Clinical Research Center Tucson Arizona Recruiting
Clermont Oncology Center Clermont Florida Terminated
Cancer Care Centers of Brevard, Inc Palm Bay Florida Recruiting
Northside Hospital Atlanta Atlanta Georgia Recruiting
Illinois Cancer Specialists Niles Illinois Recruiting
Fort Wayne Medical Oncology and Hematology, Inc Fort Wayne Indiana Recruiting
McFarland Clinic Ames Iowa Recruiting
Helen G. Nassif Community Cancer Center Cedar Rapids Iowa Recruiting
Baptist Health Hardin Cancer Center Elizabethtown Kentucky Recruiting
LSU Health Baton Rouge - North Clinic Baton Rouge Louisiana Recruiting
Our Lady of the Lake Hospital, Inc. Baton Rouge Louisiana Recruiting
Frederick Health Hospital- James M Stockman Cancer Institute Frederick Maryland Recruiting
Beth Israel Lahey Health - Lahey Hospital & Medical Center (LHMC), Lahey Clinic Medical Center Burlington Massachusetts Recruiting
Baptist Cancer Center Southaven Mississippi Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Nebraska Hematology-Oncology (NHO) Lincoln Nebraska Recruiting
Cornell University - NewYork-Presbyterian/Weill Cornell Medical Center New York New York Recruiting
White Plains Hospital White Plains New York Recruiting
Cleveland Clinic - Akron General Hematology & Oncology Akron Ohio Recruiting
Cleveland Clinic Mercy Hospital Cancer Center Canton Ohio Recruiting
The Christ Hospital Cancer Center Cincinnati Ohio Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Recruiting
The Cleveland Clinic Cancer Center at Fairview Hospital, Moll Pavilion Cleveland Ohio Recruiting
Cleveland Clinic Foundation Cleveland Ohio Recruiting
Kettering Medical Center Kettering Ohio Recruiting
Cleveland Clinic - Hillcrest Hospital Mayfield Heights Ohio Recruiting
St. Luke's Physician Group - St. Luke's Cancer Care Associates Fountain Hill Pennsylvania Recruiting
West Cancer Center & Research Institute Germantown Tennessee Recruiting
University of Tennessee Medical Center Knoxville Tennessee Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas Recruiting
Millennium Research and Clinical Development, LLC Houston Texas Terminated
Texas Oncology Cancer Center Sugar Land Texas Recruiting
Virginia Cancer Specialists Fairfax Virginia Recruiting
Hematology Oncology Associates of Fredericksburg, Inc. Fredericksburg Virginia Recruiting
Virginia Commonwealth University School of Medicine Richmond Virginia Recruiting
Shenandoah Oncology Winchester Virginia Recruiting
Calvary Mater Newcastle Waratah New South Wales Recruiting
Cancer Care Wollongong Pty Limited Wollongong New South Wales Recruiting
Cairns Hospital Cairns Queensland Recruiting
Icon Cancer Centre Kurralta Park Kurralta Park South Australia Recruiting

+ 185 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06712355 on ClinicalTrials.gov ↗ ← All trials in the UK