Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer
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
2 other identifiers
interventional
621
10 countries
138
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2025
Typical duration for phase_3
138 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2024
CompletedFirst Posted
Study publicly available on registry
December 2, 2024
CompletedStudy Start
First participant enrolled
February 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
February 13, 2026
February 1, 2026
3.8 years
November 11, 2024
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival (OS)
OS defined as the time from randomization to death from any cause.
Up to approximately 46 months
Secondary Outcomes (13)
Progression-free survival (PFS)
Up to approximately 46 months
Objective response rate (ORR)
Up to approximately 46 months
Duration of response (DOR)
Up to approximately 46 months
PFS rate based on investigator's assessment
At 6, 12, and 18 months
OS rate
At 6, 12, 18, and 24 months
- +8 more secondary outcomes
Study Arms (5)
Stage 1 Control Arm - Atezolizumab + Etoposide + Carboplatin
ACTIVE COMPARATORStage 1 Treatment Arm 1 - Pumitamig Dose 1 + Etoposide + Carboplatin
EXPERIMENTALStage 1 Treatment Arm 2 - Pumitamig Dose 2 + Etoposide + Carboplatin
EXPERIMENTALStage 2 Control Arm - Atezolizumab + Etoposide + Carboplatin
ACTIVE COMPARATORStage 2 Treatment Arm - Pumitamig Dose 3 + Etoposide + Carboplatin
EXPERIMENTALInterventions
Intravenous infusion and capsules
Intravenous infusion
Intravenous infusion
Intravenous infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioNTech SElead
- Bristol-Myers Squibbcollaborator
Study Sites (138)
Clermont Oncology Center
Clermont, Florida, 34711, United States
Cancer Care Centers of Brevard, Inc
Palm Bay, Florida, 32901, United States
Illinois Cancer Specialists
Niles, Illinois, 60714, United States
Fort Wayne Medical Oncology and Hematology, Inc
Fort Wayne, Indiana, 46804, United States
McFarland Clinic
Ames, Iowa, 50010, United States
Helen G. Nassif Community Cancer Center
Cedar Rapids, Iowa, 52403, United States
Baptist Health Hardin Cancer Center
Elizabethtown, Kentucky, 42701, United States
Frederick Health Hospital- James M Stockman Cancer Institute
Frederick, Maryland, 21704, United States
Beth Israel Lahey Health - Lahey Hospital & Medical Center (LHMC), Lahey Clinic Medical Center
Burlington, Massachusetts, 01805, United States
Baptist Cancer Center
Southaven, Mississippi, 38671, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Nebraska Hematology-Oncology (NHO)
Lincoln, Nebraska, 68506, United States
White Plains Hospital
White Plains, New York, 10601, United States
Cleveland Clinic - Akron General Hematology & Oncology
Akron, Ohio, 44302, United States
Cleveland Clinic Mercy Hospital Cancer Center
Canton, Ohio, 44708, United States
The Christ Hospital Cancer Center
Cincinnati, Ohio, 45219, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
The Cleveland Clinic Cancer Center at Fairview Hospital, Moll Pavilion
Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195-0001, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio, 44124, United States
St. Luke's Physician Group - St. Luke's Cancer Care Associates
Fountain Hill, Pennsylvania, 18015-1153, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Millennium Research and Clinical Development, LLC
Houston, Texas, 77090, United States
Texas Oncology Cancer Center
Sugar Land, Texas, 77479, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Hematology Oncology Associates of Fredericksburg, Inc.
Fredericksburg, Virginia, 22408, United States
Virginia Commonwealth University School of Medicine
Richmond, Virginia, 23298, United States
Shenandoah Oncology
Winchester, Virginia, 22601, United States
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Cancer Care Wollongong Pty Limited
Wollongong, New South Wales, 2500, Australia
Cairns Hospital
Cairns, Queensland, 4870, Australia
Icon Cancer Centre Kurralta Park
Kurralta Park, South Australia, 5037, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, 5011, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, 3199, Australia
Olivia Newton-John Cancer Wellness & Research centre
Heidelberg, Victoria, 3084, Australia
Western Health Sunshine Hospital
St Albans, Victoria, 3021, Australia
Cairns Hospital
Cairns, 4870, Australia
Royal North Shore Hospital
Saint Leonards, 2065, Australia
Jilin Cancer Hospital
Changchun, Jilin, 130012, China
Affiliated Hospital of Hebei University
Baoding, 071105, China
Beijing Friendship Hospital, Capital Medical University
Beijing, 100050, China
Peking Union Medical College Hospital
Beijing, 100730, China
Beijing Chest Hospital,Capital Medical University
Beijing, 101149, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, 233004, China
Zhejiang Medical University, Zhejiang Cancer Hospital
Hangzhou, 310022, China
Jiamusi Cancer Hospital
Jiamusi, 154007, China
Shandong University - Jinan Central Hospital
Jinan, 250013, China
Shandong Cancer Hospital and Institute
Jinan, 250117, China
Linyi Cancer Hospital
Linyi, 276034, China
The First Affiliated Hospital of Nanchang University
Nanchang, 330006, China
Jiangsu Peoples Hospital
Nanjing, 210029, China
Guangxi Tumour Hospital
Nanning, 530000, China
Shanghai Chest Hospital
Shanghai, 200030, China
Fudan University - Shanghai Cancer Center (FUSCC)
Shanghai, 200032, China
Cancer Hospital of Shantou University Medical College
Shantou, 515041, China
The First Affiliated Hospital of Soochow University
Suzhou, 215006, China
Shanxi Provincial Tumor Hospital (Shanxi Oncology Hospital)
Taiyuan, 030013, China
Chongqing University Three Gorges Hospital
Wanzhou, 404000, China
The First Affiliated Hospital Of Wenzhou Medical University
Wenzhou, 325000, China
Zhongnan Hospital of Wuhan University
Wuhan, 430071, China
Xiangyang Central Hospital
Xiangyang, 441000, China
The First Affiliated Hospital of Henan Medical University
Xinxiang, 453100, China
Northern Jiangsu Peoples Hospital (NJPH)
Yangzhou, 225001, China
Taizhou Hospital of Zhejiang Province
Zhejiang, 317000, China
Evangelische Lungenklinik Berlin
Berlin, 13125, Germany
Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling
Bonn, 53123, Germany
SRH Wald-Kliniken Gera GmbH
Gera, 07548, Germany
LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927, Germany
MVZ for oncology and hematology Rhein-Kreis Neuss GmbH
Neuss, 41462, Germany
Helios Klinikum Wuppertal-Universitaet Witten-Herdecke
Wuppertal, 42283, Germany
Tokyo Metropolitan Komagome Hospital
Bunkyō City, 113-8677, Japan
National Cancer Center Hospital
Chūōku, 104-0045, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
National Hospital Organization Himeji Medical Center
Himeji, 670-8520, Japan
National Hospital Organization Iwakuni Clinical Center
Iwakuni, 740-8510, Japan
Kurume University Hospital
Kurume, 830-0011, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, 791-0280, Japan
Sendai Kousei Hospital
Miyagi, 981-0914, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Osaka, 541-8567, Japan
NHO Kinki Chuo Chest Medical Center
Sakai, 591-8555, Japan
KOMED Roman Karaszewski I Wspolnicy Spolka Jawna
Konin, 62-500, Poland
FutureMeds Krakow
Krakow, 31-501, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
Przemyśl, 37-700, Poland
Korea University Guro Hospital
Seoul, Guro-gu, 8308, South Korea
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
The Catholic University Of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, 16499, South Korea
Gyeongsang National University Hospital (GNUH)
Jinju, Gyeongsangnam-do, 52727, South Korea
Gachon University Gil Medical Center
Incheon, Namdong-gu, 21565, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 3722, South Korea
Asan Medical Center (AMC)
Seoul, 5505, South Korea
Samsung Medical Center
Seoul, 6351, South Korea
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid, 28007, Spain
Hospital Universitario Nuestra Senora De Valme
Seville, 41014, Spain
Hospital Clinico Universitario Lozano Blesa de Zaragoza
Zaragoza, 50009, Spain
Acibadem Adana Hospital
Adana, 1130, Turkey (Türkiye)
Seyhan Medical Park Hospital
Adana, 1140, Turkey (Türkiye)
Baskent University Adana Turgut Noyan Application and Research Center
Adana, 1250, Turkey (Türkiye)
Ankara Etlik City Hospital
Ankara, 06170, Turkey (Türkiye)
Gulhane Training and Research Hospital
Ankara, 6010, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, 6200, Turkey (Türkiye)
Hacettepe University Medical Faculty Hospital
Ankara, 6230, Turkey (Türkiye)
Memorial Ankara Hospital
Ankara, 6520, Turkey (Türkiye)
Gazi University, Medical Faculty Hospital
Ankara, 6560, Turkey (Türkiye)
Liv Hospital Ankara
Ankara, 6680, Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, 6800, Turkey (Türkiye)
Akdeniz University Hospital
Antalya, Turkey (Türkiye)
Trakya University Faculty of Medicine
Edirne, 22030, Turkey (Türkiye)
Koc Universitesi Hastanesi (Koc University Hospital)
Istanbul, 34010, Turkey (Türkiye)
Medical Park Florya Hospital
Istanbul, 34295, Turkey (Türkiye)
Yeditepe University Kosuyolu Hospital
Istanbul, 34718, Turkey (Türkiye)
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, 41380, Turkey (Türkiye)
Medical Point Izmir Hospital
Izmir, 35575, Turkey (Türkiye)
Kocaeli University Medical Faculty Hospital
Kocaeli, 41380, Turkey (Türkiye)
Ankara University Medical Faculty Hospital
Mamak, 06220, Turkey (Türkiye)
Sakarya University Training and Research Hospital
Sakarya, 54290, Turkey (Türkiye)
The Christie NHS Foundation Trust
Manchester, Lancashire, M20 4BX, United Kingdom
Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust
Chelsea, London, SW3 6JJ, United Kingdom
Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust
Sutton, London, SM2 5PT, United Kingdom
Huddersfield Royal Infirmary - Calderdale and Huddersfield NHS Foundation Trust
Huddersfield, North Yorkshire, HD3 3EA, United Kingdom
Northern Centre for Cancer Care - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Northumberland, NE7 7DN, United Kingdom
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
Churchill Hospital - Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 7LE, United Kingdom
Ninewells Hospital and Medical School - Tayside Health Board
Dundee, Scotland, DD1 9SY, United Kingdom
Torbay and South Devon NHS Foundation Trust
Torquay, South Devon, TQ2 7AA, United Kingdom
Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom
Velindre NHS Trust, Velindre Cancer Centre
Cardiff, Wales, CF14 2TL, United Kingdom
New Cross Hospital
Wolverhampton, West Midlands, WV10 0QP, United Kingdom
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
Hull University Teaching Hospitals NHS Trust
Cottingham, HU16 5JQ, United Kingdom
Royal Devon and Exeter Hospital, Royal Devon University Healthcare NHS Foundation Trust
Exeter, EX2 5DW, United Kingdom
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF, United Kingdom
Guy's Hospital - Guy's & St Thomas' NHS Foundation Trust
London, SE1 9RT, United Kingdom
Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
Preston, PR2 9HT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
BioNTech Responsible Person
BioNTech SE
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2024
First Posted
December 2, 2024
Study Start
February 3, 2025
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
March 1, 2029
Last Updated
February 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share