Clinical trial Recruiting at 188 sites Phase 3 Interventional Ages 18 and up

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.

More Extensive-stage Small-cell Lung Cancer trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment621 (estimated)
SponsorBioNTech SE
Industry-sponsored
Drugs / interventionschemotherapy, radiation, prednisone, atezolizumab
Locations225 sites (Tucson, Arizona and 224 other locations)
StatusRecruiting
StartedFebruary 3, 2025
Main results expectedApril 2029
Study endsJuly 2029
Registry record updatedOctober 14, 2026
Trial IDNCT06712355 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.