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Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer
Sponsor: BioNTech SE
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
2029-03
Last Updated
2026-02-13
Healthy Volunteers
No
Conditions
Interventions
Pumitamig
Intravenous infusion
Atezolizumab
Intravenous infusion
Etoposide
Intravenous infusion and capsules
Carboplatin (or cisplatin if carboplatin is not tolerated)
Intravenous infusion
Locations (138)
Clermont Oncology Center
Clermont, Florida, United States
Cancer Care Centers of Brevard, Inc
Palm Bay, Florida, 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
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
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
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
Royal North Shore Hospital
Saint Leonards, 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
Zhejiang Medical University, Zhejiang Cancer Hospital
Hangzhou, China
Jiamusi Cancer Hospital
Jiamusi, China
Shandong University - Jinan Central Hospital
Jinan, China
Shandong Cancer Hospital and Institute
Jinan, 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
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
Evangelische Lungenklinik Berlin
Berlin, Germany
Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling
Bonn, Germany
SRH Wald-Kliniken Gera GmbH
Gera, Germany
LungenClinic Grosshansdorf GmbH
Großhansdorf, Germany
MVZ for oncology and hematology Rhein-Kreis Neuss GmbH
Neuss, Germany
Helios Klinikum Wuppertal-Universitaet Witten-Herdecke
Wuppertal, Germany
Tokyo Metropolitan Komagome Hospital
Bunkyō City, Japan
National Cancer Center Hospital
Chūōku, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan
National Hospital Organization Himeji Medical Center
Himeji, Japan
National Hospital Organization Iwakuni Clinical Center
Iwakuni, Japan
Kurume University Hospital
Kurume, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Japan
Sendai Kousei Hospital
Miyagi, Japan
Niigata Cancer Center Hospital
Niigata, Japan
Okayama University Hospital
Okayama, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Osaka, Japan
NHO Kinki Chuo Chest Medical Center
Sakai, Japan
KOMED Roman Karaszewski I Wspolnicy Spolka Jawna
Konin, Poland
FutureMeds Krakow
Krakow, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
Przemyśl, Poland
Korea University Guro Hospital
Seoul, Guro-gu, South Korea
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
The Catholic University Of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Gyeongsang National University Hospital (GNUH)
Jinju, Gyeongsangnam-do, South Korea
Gachon University Gil Medical Center
Incheon, Namdong-gu, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Center (AMC)
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid, Spain
Hospital Universitario Nuestra Senora De Valme
Seville, Spain
Hospital Clinico Universitario Lozano Blesa de Zaragoza
Zaragoza, Spain
Acibadem Adana Hospital
Adana, Turkey (Türkiye)
Seyhan Medical Park Hospital
Adana, Turkey (Türkiye)
Baskent University Adana Turgut Noyan Application and Research Center
Adana, Turkey (Türkiye)
Ankara Etlik City Hospital
Ankara, Turkey (Türkiye)
Gulhane Training and Research Hospital
Ankara, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, Turkey (Türkiye)
Hacettepe University Medical Faculty Hospital
Ankara, Turkey (Türkiye)
Memorial Ankara Hospital
Ankara, Turkey (Türkiye)
Gazi University, Medical Faculty Hospital
Ankara, Turkey (Türkiye)
Liv Hospital Ankara
Ankara, Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye)
Akdeniz University Hospital
Antalya, Turkey (Türkiye)
Trakya University Faculty of Medicine
Edirne, Turkey (Türkiye)
Koc Universitesi Hastanesi (Koc University Hospital)
Istanbul, Turkey (Türkiye)
Medical Park Florya Hospital
Istanbul, Turkey (Türkiye)
Yeditepe University Kosuyolu Hospital
Istanbul, Turkey (Türkiye)
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, Turkey (Türkiye)
Medical Point Izmir Hospital
Izmir, Turkey (Türkiye)
Kocaeli University Medical Faculty Hospital
Kocaeli, Turkey (Türkiye)
Ankara University Medical Faculty Hospital
Mamak, Turkey (Türkiye)
Sakarya University Training and Research Hospital
Sakarya, Turkey (Türkiye)
The Christie NHS Foundation Trust
Manchester, Lancashire, United Kingdom
Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust
Chelsea, London, United Kingdom
Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust
Sutton, London, United Kingdom
Huddersfield Royal Infirmary - Calderdale and Huddersfield NHS Foundation Trust
Huddersfield, North Yorkshire, United Kingdom
Northern Centre for Cancer Care - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Northumberland, United Kingdom
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
Nottingham, Nottinghamshire, United Kingdom
Churchill Hospital - Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom
Ninewells Hospital and Medical School - Tayside Health Board
Dundee, Scotland, United Kingdom
Torbay and South Devon NHS Foundation Trust
Torquay, South Devon, United Kingdom
Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, United Kingdom
Velindre NHS Trust, Velindre Cancer Centre
Cardiff, Wales, United Kingdom
New Cross Hospital
Wolverhampton, West Midlands, United Kingdom
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Hull University Teaching Hospitals NHS Trust
Cottingham, United Kingdom
Royal Devon and Exeter Hospital, Royal Devon University Healthcare NHS Foundation Trust
Exeter, United Kingdom
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Guy's Hospital - Guy's & St Thomas' NHS Foundation Trust
London, United Kingdom
Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
Preston, United Kingdom