Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer
NCT ID: NCT06712355
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
621 participants
INTERVENTIONAL
2025-02-03
2029-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Each stage of the study consists of a screening period (up to 21 days), an induction period followed by a maintenance period (until confirmed disease progression, intolerable toxicity, participant withdrawal, study termination or up to 2 years \[whichever occurs first\]), and a follow-up (FU) period for all participants (2 safety FU visits and survival FU visits).
In Stage 1, eligible participants will be randomized (1:1:1) to the arms. In Stage 2, participants will then be randomized (1:1) to the arms. The randomization will be stratified based on the following factors:
1. Brain or liver metastases per investigator assessment (presence versus absence);
2. Smoking status (smoker versus never-smoker); and
3. Geography.
Participants will be allowed to switch to cisplatin if carboplatin is not tolerated at the investigator's discretion.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Stage 1 Control Arm - Atezolizumab + Etoposide + Carboplatin
Atezolizumab
Intravenous infusion
Etoposide
Intravenous infusion and capsules
Carboplatin (or cisplatin if carboplatin is not tolerated)
Intravenous infusion
Stage 1 Treatment Arm 1 - Pumitamig Dose 1 + Etoposide + Carboplatin
Pumitamig
Intravenous infusion
Etoposide
Intravenous infusion and capsules
Carboplatin (or cisplatin if carboplatin is not tolerated)
Intravenous infusion
Stage 1 Treatment Arm 2 - Pumitamig Dose 2 + Etoposide + Carboplatin
Pumitamig
Intravenous infusion
Etoposide
Intravenous infusion and capsules
Carboplatin (or cisplatin if carboplatin is not tolerated)
Intravenous infusion
Stage 2 Control Arm - Atezolizumab + Etoposide + Carboplatin
Atezolizumab
Intravenous infusion
Etoposide
Intravenous infusion and capsules
Carboplatin (or cisplatin if carboplatin is not tolerated)
Intravenous infusion
Stage 2 Treatment Arm - Pumitamig Dose 3 + Etoposide + Carboplatin
Pumitamig
Intravenous infusion
Etoposide
Intravenous infusion and capsules
Carboplatin (or cisplatin if carboplatin is not tolerated)
Intravenous infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pumitamig
Intravenous infusion
Atezolizumab
Intravenous infusion
Etoposide
Intravenous infusion and capsules
Carboplatin (or cisplatin if carboplatin is not tolerated)
Intravenous infusion
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
BioNTech SE
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
BioNTech Responsible Person
Role: STUDY_DIRECTOR
BioNTech SE
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clermont Oncology Center
Clermont, Florida, United States
Cancer Care Centers of Brevard, Inc
Palm Bay, Florida, 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
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
Kettering Medical Center
Kettering, Ohio, 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
Hematology Oncology Associates of Fredericksburg, Inc.
Fredericksburg, 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
Tokyo Metropolitan Komagome Hospital
Bunkyō City, , Japan
National Hospital Organization Himeji Medical Center
Himeji, , Japan
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
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)
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)
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
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-515765-34-00
Identifier Type: CTIS
Identifier Source: secondary_id
BNT327-03
Identifier Type: -
Identifier Source: org_study_id