Investigating BNT327 with chemotherapy for untreated small-cell lung cancer
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
Run by BioNTech SE · NCT06712355 · Data updated 2026-11-12
This study is testing whether a new treatment called BNT327, combined with standard chemotherapy, can help people with untreated extensive-stage small-cell lung cancer feel better compared to another treatment option.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 621 (estimated) |
| Sponsor | BioNTech SE Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation, prednisone, atezolizumab |
| Locations | 225 sites (Tucson, Arizona and 224 other locations) |
| Status | Recruiting |
| Started | February 3, 2025 |
| Main results expected | April 2029 |
| Study ends | July 2029 |
| Registry record updated | October 14, 2026 |
| Trial ID | NCT06712355 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with histologically or cytologically confirmed extensive-stage small-cell lung cancer who have not received prior systemic therapy.
✕Probably not a fit
Patients with limited-stage small-cell lung cancer who have received prior systemic therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase III, multisite, randomized, double-blinded study aims to evaluate the safety and effectiveness of BNT327 in combination with chemotherapy (etoposide/carboplatin) compared to atezolizumab with chemotherapy for patients with untreated extensive-stage small-cell lung cancer (ES-SCLC). Participants will undergo a screening period followed by an induction and maintenance phase, with randomization occurring based on specific factors such as the presence of brain or liver metastases. The study will continue until disease progression, intolerable toxicity, or up to two years, with follow-up visits for safety and survival assessments.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with untreated extensive-stage small-cell lung cancer.
How similar studies have gone: Other studies have shown promise with similar immunotherapy approaches in treating small-cell lung cancer, but this specific combination is being evaluated for the first time.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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ACRC Arizona Clinical Research Center
Tucson, Arizona, United States Recruiting -
Cancer Care Centers of Brevard, Inc
Palm Bay, Florida, United States Recruiting -
Northside Hospital Atlanta
Atlanta, Georgia, United States Recruiting -
Illinois Cancer Specialists
Niles, Illinois, United States Recruiting -
Fort Wayne Medical Oncology and Hematology, Inc
Fort Wayne, Indiana, United States Recruiting -
McFarland Clinic
Ames, Iowa, United States Recruiting
Show 44 more locations
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Helen G. Nassif Community Cancer Center
Cedar Rapids, Iowa, United States Recruiting -
Baptist Health Hardin Cancer Center
Elizabethtown, Kentucky, United States Recruiting -
LSU Health Baton Rouge - North Clinic
Baton Rouge, Louisiana, United States Recruiting -
Our Lady of the Lake Hospital, Inc.
Baton Rouge, Louisiana, United States Recruiting -
Frederick Health Hospital- James M Stockman Cancer Institute
Frederick, Maryland, United States Recruiting -
Beth Israel Lahey Health - Lahey Hospital & Medical Center (LHMC), Lahey Clinic Medical Center
Burlington, Massachusetts, United States Recruiting -
Baptist Cancer Center
Southaven, Mississippi, United States Recruiting -
Washington University School of Medicine
St Louis, Missouri, United States Recruiting -
Nebraska Hematology-Oncology (NHO)
Lincoln, Nebraska, United States Recruiting -
Cornell University - NewYork-Presbyterian/Weill Cornell Medical Center
New York, New York, United States Recruiting -
White Plains Hospital
White Plains, New York, United States Recruiting -
Cleveland Clinic - Akron General Hematology & Oncology
Akron, Ohio, United States Recruiting -
Cleveland Clinic Mercy Hospital Cancer Center
Canton, Ohio, United States Recruiting -
The Christ Hospital Cancer Center
Cincinnati, Ohio, United States Recruiting -
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States Recruiting -
The Cleveland Clinic Cancer Center at Fairview Hospital, Moll Pavilion
Cleveland, Ohio, United States Recruiting -
Cleveland Clinic Foundation
Cleveland, Ohio, United States Recruiting -
Kettering Medical Center
Kettering, Ohio, United States Recruiting -
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio, United States Recruiting -
St. Luke's Physician Group - St. Luke's Cancer Care Associates
Fountain Hill, Pennsylvania, United States Recruiting -
West Cancer Center & Research Institute
Germantown, Tennessee, United States Recruiting -
University of Tennessee Medical Center
Knoxville, Tennessee, United States Recruiting -
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States Recruiting -
Texas Oncology Cancer Center
Sugar Land, Texas, United States Recruiting -
Virginia Cancer Specialists
Fairfax, Virginia, United States Recruiting -
Hematology Oncology Associates of Fredericksburg, Inc.
Fredericksburg, Virginia, United States Recruiting -
Virginia Commonwealth University School of Medicine
Richmond, Virginia, United States Recruiting -
Shenandoah Oncology
Winchester, Virginia, United States Recruiting -
Calvary Mater Newcastle
Waratah, New South Wales, Australia Recruiting -
Cancer Care Wollongong Pty Limited
Wollongong, New South Wales, Australia Recruiting -
Cairns Hospital
Cairns, Queensland, Australia Recruiting -
Icon Cancer Centre Kurralta Park
Kurralta Park, South Australia, Australia Recruiting -
The Queen Elizabeth Hospital
Woodville, South Australia, Australia Recruiting -
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia Recruiting -
Olivia Newton-John Cancer Wellness & Research centre
Heidelberg, Victoria, Australia Recruiting -
Western Health Sunshine Hospital
St Albans, Victoria, Australia Recruiting -
Cairns Hospital
Cairns, Australia Recruiting -
Sir Charles Gairdner Hospital (SCGH)
Nedlands, Australia Recruiting -
Royal North Shore Hospital
Saint Leonards, Australia Recruiting -
Liverpool Hospital
Sydney, Australia Recruiting -
Centre Hospitalier Universitaire d'Angers (CHU Angers)
Angers, France Recruiting -
Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, France Recruiting -
CHU de Caen
Caen, France Recruiting -
Institut Curie - Centre de Recherche
Paris, France Recruiting
+175 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: BioNTech clinical trials patient information
- Email: patients@biontech.de
- Phone: +49 6131 9084
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BL-M14D1 with Atezolizumab for extensive-stage small cell lung cancer
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Combining Bevacizumab with Chemoimmunotherapy for Advanced Lung Cancer with Liver Metastases
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.