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RECRUITING

NCT06712355

PHASE3

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

Sponsor: BioNTech SE

View on ClinicalTrials.gov

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).

Official title: A Phase III, Multisite, Double-blinded Randomized Trial of BNT327 in Combination With Chemotherapy (Etoposide/Carboplatin) Compared to Atezolizumab in Combination With Chemotherapy (Etoposide/Carboplatin) in Participants With First-line Extensive-stage Small-cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

621

Start Date

2025-02-03

Completion Date

2029-07

Last Updated

2026-10-14

Healthy Volunteers

Conditions

Extensive-stage Small-cell Lung Cancer

Interventions

DRUG

Pumitamig

Intravenous infusion

DRUG

Atezolizumab

Intravenous infusion

DRUG

Etoposide

Intravenous infusion and capsules

DRUG

Carboplatin (or cisplatin if carboplatin is not tolerated)

Intravenous infusion

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.

Locations (225)

ACRC Arizona Clinical Research Center

Tucson, Arizona, United States

Clermont Oncology Center

Clermont, Florida, United States

Cancer Care Centers of Brevard, Inc

Palm Bay, Florida, United States

Northside Hospital Atlanta

Atlanta, Georgia, United States

Illinois Cancer Specialists

Niles, Illinois, United States

Fort Wayne Medical Oncology and Hematology, Inc

Fort Wayne, Indiana, United States

McFarland Clinic

Ames, Iowa, United States

Helen G. Nassif Community Cancer Center

Cedar Rapids, Iowa, United States

Baptist Health Hardin Cancer Center

Elizabethtown, Kentucky, United States

LSU Health Baton Rouge - North Clinic

Baton Rouge, Louisiana, United States

Our Lady of the Lake Hospital, Inc.

Baton Rouge, Louisiana, United States

Frederick Health Hospital- James M Stockman Cancer Institute

Frederick, Maryland, United States

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

Burlington, Massachusetts, United States

Baptist Cancer Center

Southaven, Mississippi, United States

Washington University School of Medicine

St Louis, Missouri, United States

Nebraska Hematology-Oncology (NHO)

Lincoln, Nebraska, United States

Cornell University - NewYork-Presbyterian/Weill Cornell Medical Center

New York, New York, United States

White Plains Hospital

White Plains, New York, United States

Cleveland Clinic - Akron General Hematology & Oncology

Akron, Ohio, United States

Cleveland Clinic Mercy Hospital Cancer Center

Canton, Ohio, United States

The Christ Hospital Cancer Center

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

The Cleveland Clinic Cancer Center at Fairview Hospital, Moll Pavilion

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Kettering Medical Center

Kettering, Ohio, United States

Cleveland Clinic - Hillcrest Hospital

Mayfield Heights, Ohio, United States

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

Fountain Hill, Pennsylvania, United States

West Cancer Center & Research Institute

Germantown, Tennessee, United States

University of Tennessee Medical Center

Knoxville, Tennessee, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Millennium Research and Clinical Development, LLC

Houston, Texas, United States

Texas Oncology Cancer Center

Sugar Land, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Hematology Oncology Associates of Fredericksburg, Inc.

Fredericksburg, Virginia, United States

Virginia Commonwealth University School of Medicine

Richmond, Virginia, United States

Shenandoah Oncology

Winchester, Virginia, United States

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Cancer Care Wollongong Pty Limited

Wollongong, New South Wales, Australia

Cairns Hospital

Cairns, Queensland, Australia

Icon Cancer Centre Kurralta Park

Kurralta Park, South Australia, Australia

The Queen Elizabeth Hospital

Woodville, South Australia, Australia

Peninsula & South Eastern Haematology and Oncology Group

Frankston, Victoria, Australia

Olivia Newton-John Cancer Wellness & Research centre

Heidelberg, Victoria, Australia

Western Health Sunshine Hospital

St Albans, Victoria, Australia

Cairns Hospital

Cairns, Australia

Sir Charles Gairdner Hospital (SCGH)

Nedlands, Australia

Royal North Shore Hospital

Saint Leonards, Australia

Liverpool Hospital

Sydney, Australia

Jilin Cancer Hospital

Changchun, Jilin, China

Affiliated Hospital of Hebei University

Baoding, China

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Peking Union Medical College Hospital

Beijing, China

Beijing Chest Hospital,Capital Medical University

Beijing, China

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Fujian Provincial Cancer Hospital

Fuzhou, China

Guangdong General Hospital

Guangzhou, China

Zhejiang Medical University, Zhejiang Cancer Hospital

Hangzhou, China

Harbin Medical University Cancer Hospital

Ha’erbin, China

Cancer Hospital Chinese Academy of Medical Sciences

Hebei, China

Anhui Provincial Hospital

Hefei, China

Jiamusi Cancer Hospital

Jiamusi, China

Shandong University - Jinan Central Hospital

Jinan, China

Shandong Cancer Hospital and Institute

Jinan, China

Yunnan Provincial Cancer Hospital

Kunming, China

Linyi Cancer Hospital

Linyi, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

Jiangsu Peoples Hospital

Nanjing, China

Guangxi Tumour Hospital

Nanning, China

Shanghai Chest Hospital

Shanghai, China

Fudan University - Shanghai Cancer Center (FUSCC)

Shanghai, China

Cancer Hospital of Shantou University Medical College

Shantou, China

The First Affiliated Hospital of Soochow University

Suzhou, China

Shanxi Provincial Tumor Hospital (Shanxi Oncology Hospital)

Taiyuan, China

Chongqing University Three Gorges Hospital

Wanzhou, China

The First Affiliated Hospital Of Wenzhou Medical University

Wenzhou, China

Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST)

Wuhan, China

Zhongnan Hospital of Wuhan University

Wuhan, China

Xiangyang Central Hospital

Xiangyang, China

The First Affiliated Hospital of Henan Medical University

Xinxiang, China

Northern Jiangsu Peoples Hospital (NJPH)

Yangzhou, China

Taizhou Hospital of Zhejiang Province

Zhejiang, China

Henan Cancer Hospital (Affiliated Cancer Hospital of Zhengzhou University)

Zhengzhou, China

Centre Hospitalier Universitaire d'Angers (CHU Angers)

Angers, France

Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

Bordeaux, France

CHU de Caen

Caen, France

Institut Curie - Centre de Recherche

Paris, France

CHU de Rennes, Hopital de Pontchaillou

Rennes, France

Institut de Cancerologie de l'Ouest (ICO)- CRLCC Rene Gauducheau

Saint-Herblain, France

Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hopital Sainte Musse

Toulon, France

Evangelische Lungenklinik Berlin

Berlin, Germany

Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)

Berlin, Germany

Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling

Bonn, Germany

Klinikum Chemnitz Gmbh

Chemnitz, Germany

Klinikum Esslingen GmbH

Esslingen am Neckar, Germany

Asklepios Fachkliniken Muenchen Gauting

Gauting, Germany

SRH Wald-Kliniken Gera GmbH

Gera, Germany

LungenClinic Grosshansdorf GmbH

Großhansdorf, Germany

Krankenhaus Martha-Maria Halle-Doelau gGmbH

Halle, Germany

Klinikum Kempten-Oberallgau gGmbH

Kempten, Germany

Universitaetsklinikum Schleswig-Holstein (UKSH) - Campus Luebeck

Lübeck, Germany

And 125 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (225)