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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: BioNTech SE • ClinicalTrials.gov ID: NCT06712355

Registry updated: 2026-10-14
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Description

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).

Interventions

  • Pumitamig (Drug)
    Intravenous infusion
  • Atezolizumab (Drug)
    Intravenous infusion
  • Etoposide (Drug)
    Intravenous infusion and capsules
  • Carboplatin (or cisplatin if carboplatin is not tolerated) (Drug)
    Intravenous infusion

Eligibility criteria

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.

Conditions

Extensive-stage Small-cell Lung Cancer

Locations

  • 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
  • University Medical Center of Johannes Gutenberg-University Mainz — Mainz, Germany
  • Staedtisches Klinikum Muenchen Bogenhausen — München, Germany
  • MVZ for oncology and hematology Rhein-Kreis Neuss GmbH — Neuss, Germany
  • Klinikum Nuernberg Nord — Nuremberg, Germany
  • Helios Klinikum Wuppertal-Universitaet Witten-Herdecke — Wuppertal, Germany
  • Azienda Ospedaliera San Giuseppe Moscati — Avellino, Italy
  • Centro di Riferimento Oncologico — Aviano, Italy
  • Azienda Socio Sanitaria Territoriale di Cremona — Cremona, Italy
  • Ospedale San Luca — Lucca, Italy
  • IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" (IRST) — Meldola, Italy
  • Universita Degli Studi Di Milano-Bicocca - Azienda Ospedaliera San Gerardo Di Monza — Monza, Italy
  • UOC Oncoematologia AOU Luigi Vanvitelli — Naples, Italy
  • Casa Di Cura Polispecialistica Dott Pederzoli — Peschiera del Garda, Italy
  • Ageo Central General Hospital — Ageo, Japan
  • Tokyo Metropolitan Komagome Hospital — Bunkyō City, Japan
  • National Cancer Center Hospital — Chūōku, Japan
  • National Hospital Organization Kyushu Cancer Center — Fukuoka, Japan
  • Saitama Medical University International Medical Center — Hidaka, Japan
  • National Hospital Organization Himeji Medical Center — Himeji, Japan
  • National Hospital Organization Iwakuni Clinical Center — Iwakuni, Japan
  • Kobe City Medical Center General Hospital — Kobe, Japan
  • Kurume University Hospital — Kurume, Japan
  • Matsusaka Municipal Hospital — Matsusaka, Japan
  • National Hospital Organization Shikoku Cancer Center — Matsuyama, Japan
  • Sendai Kousei Hospital — Miyagi, Japan
  • National Hospital Organization Nagoya Medical Center — Nagoya, Japan
  • Niigata Cancer Center Hospital — Niigata, Japan
  • Okayama University Hospital — Okayama, Japan
  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute — Osaka, Japan
  • Saitama Prefectural Cancer Center — Saitama, Japan
  • NHO Kinki Chuo Chest Medical Center — Sakai, Japan
  • Shibukawa Medical Center — Shibukawa, Japan
  • National Hospital Organization Yamaguchi-Ube Medical Center — Ube, Japan
  • Yokohama Municipal Citizen's Hospital — Yokohama, Japan
  • Kanagawa Cancer Center — Yokohama, Japan
  • Jeroen Bosch Ziekenhuis — 's-Hertogenbosch, Netherlands
  • Uniwersyteckie Centrum Kliniczne — Gdansk, Poland
  • Katowickie Centrum Onkologii — Katowice, Poland
  • Pratia Onkologia Katowice — Katowice, Poland
  • KOMED Roman Karaszewski I Wspolnicy Spolka Jawna — Konin, Poland
  • Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie — Koszalin, Poland
  • FutureMeds Krakow — Krakow, Poland
  • N.Copernicus Memorial Hospital — Lodz, Poland
  • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie — Lublin, Poland
  • Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie — Olsztyn, Poland
  • Wielkopolskie Centrum Pulmonologii i Tarakochirurgii — Poznan, Poland
  • Pratia S.A. , Pratia Poznan — Poznan, Poland
  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu — Przemyśl, Poland
  • Maria Sklodowska Curie National Research Institute of Oncology — Warsaw, Poland
  • Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy — Warsaw, Poland
  • Pratia Wroclaw Onkologia — Wroclaw, Poland
  • SC Oncopremium Team SRL — Baia Mare, Romania
  • Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti (IOB) — Bucharest, Romania
  • Coltea Clinical Hospital — Bucharest, Romania
  • Cardiomed — Cluj-Napoca, Romania
  • Centrul de Oncologie Sf. Nectarie S.R.L (Sf Nectarie Oncology Center) — Craiova, Romania
  • Centrul de Oncologie Euroclinic srl — Iași, Romania
  • City Hospital Onesti — Onești, Romania
  • Oncocenter Oncologie Clinica S.R.L — Timișoara, Romania
  • Oncomed — Timișoara, Romania
  • 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
  • Chungbuk National University Hospital — Cheongju-si, 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 Universitario de Badajoz — Badajoz, Spain
  • Parc de Salut Mar - Hospital del Mar — Barcelona, Spain
  • UOMI Cancer Center-Clinica Tres Torres — Barcelona, Spain
  • Hospital Universitario Vall d'Hebron — Barcelona, Spain
  • Consorcio Hospitalario Provincial de Castellon — Castellon, Spain
  • Hospital Universitario De Leon — León, Spain
  • Hospital General Universitario Gregorio Maranon (HGUGM) — Madrid, Spain
  • Clinica MD Anderson International — Madrid, Spain
  • Hospital Regional Universitario de Malaga — Málaga, Spain
  • Universidad de Sevilla - Hospital Universitario Virgen Macarena — Seville, Spain
  • Hospital Universitario Nuestra Senora De Valme — Seville, Spain
  • Hospital Universitario de Torrejón — Torrejón de Ardoz, Spain
  • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur) — Valencia, Spain
  • Hospital Alvaro Cunqueiro — Vigo, 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)
  • Marmara University Pendik Training and Research 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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