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

Status: Recruiting
Location: See all (72) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Florida
Clermont Oncology Center
TERMINATED
Clermont
Cancer Care Centers of Brevard, Inc
RECRUITING
Palm Bay
Iowa
McFarland Clinic
RECRUITING
Ames
Helen G. Nassif Community Cancer Center
RECRUITING
Cedar Rapids
Indiana
Fort Wayne Medical Oncology and Hematology, Inc
RECRUITING
Fort Wayne
Kentucky
Baptist Health Hardin Cancer Center
RECRUITING
Elizabethtown
Massachusetts
Beth Israel Lahey Health - Lahey Hospital & Medical Center (LHMC), Lahey Clinic Medical Center
RECRUITING
Burlington
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Mississippi
Baptist Cancer Center
RECRUITING
Southaven
Nebraska
Nebraska Hematology-Oncology (NHO)
RECRUITING
Lincoln
New York
White Plains Hospital
RECRUITING
White Plains
Ohio
Kettering Medical Center
RECRUITING
Kettering
Tennessee
University of Tennessee Medical Center
RECRUITING
Knoxville
Texas
Millennium Research and Clinical Development, LLC
TERMINATED
Houston
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Virginia
Hematology Oncology Associates of Fredericksburg, Inc.
RECRUITING
Fredericksburg
Other Locations
Australia
Cairns Hospital
RECRUITING
Cairns
Cairns Hospital
RECRUITING
Cairns
Peninsula & South Eastern Haematology and Oncology Group
RECRUITING
Frankston
Olivia Newton-John Cancer Wellness & Research centre
RECRUITING
Heidelberg
Icon Cancer Centre Kurralta Park
RECRUITING
Kurralta Park
Royal North Shore Hospital
RECRUITING
Saint Leonards
Western Health Sunshine Hospital
RECRUITING
St Albans
Calvary Mater Newcastle
RECRUITING
Waratah
Cancer Care Wollongong Pty Limited
RECRUITING
Wollongong
The Queen Elizabeth Hospital
RECRUITING
Woodville
China
Jilin Cancer Hospital
RECRUITING
Changchun
Japan
Tokyo Metropolitan Komagome Hospital
RECRUITING
Bunkyō City
National Hospital Organization Himeji Medical Center
RECRUITING
Himeji
Republic of Korea
National Cancer Center
RECRUITING
Goyang-si
Gachon University Gil Medical Center
RECRUITING
Incheon
Gyeongsang National University Hospital (GNUH)
RECRUITING
Jinju
Asan Medical Center (AMC)
RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
The Catholic University Of Korea, St. Vincent's Hospital
RECRUITING
Suwon
Turkey
Acibadem Adana Hospital
RECRUITING
Adana
Baskent University Adana Turgut Noyan Application and Research Center
RECRUITING
Adana
Seyhan Medical Park Hospital
RECRUITING
Adana
Ankara Bilkent City Hospital
ACTIVE_NOT_RECRUITING
Ankara
Ankara Etlik City Hospital
RECRUITING
Ankara
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
RECRUITING
Ankara
Gazi University, Medical Faculty Hospital
RECRUITING
Ankara
Gulhane Training and Research Hospital
RECRUITING
Ankara
Hacettepe University Medical Faculty Hospital
RECRUITING
Ankara
Liv Hospital Ankara
ACTIVE_NOT_RECRUITING
Ankara
Memorial Ankara Hospital
RECRUITING
Ankara
Akdeniz University Hospital
RECRUITING
Antalya
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
RECRUITING
Istanbul
Koc Universitesi Hastanesi (Koc University Hospital)
RECRUITING
Istanbul
Medical Park Florya Hospital
RECRUITING
Istanbul
Yeditepe University Kosuyolu Hospital
RECRUITING
Istanbul
Medical Point Izmir Hospital
RECRUITING
Izmir
Kocaeli University Medical Faculty Hospital
RECRUITING
Kocaeli
Sakarya University Training and Research Hospital
RECRUITING
Sakarya
United Kingdom
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
RECRUITING
Cambridge
Velindre NHS Trust, Velindre Cancer Centre
RECRUITING
Cardiff
Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust
RECRUITING
Chelsea
Hull University Teaching Hospitals NHS Trust
RECRUITING
Cottingham
Ninewells Hospital and Medical School - Tayside Health Board
RECRUITING
Dundee
Huddersfield Royal Infirmary - Calderdale and Huddersfield NHS Foundation Trust
RECRUITING
Huddersfield
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
RECRUITING
Leeds
The Christie NHS Foundation Trust
ACTIVE_NOT_RECRUITING
Manchester
Northern Centre for Cancer Care - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
RECRUITING
Newcastle Upon Tyne
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
ACTIVE_NOT_RECRUITING
Nottingham
Churchill Hospital - Oxford University Hospitals NHS Foundation Trust
RECRUITING
Oxford
Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust
ACTIVE_NOT_RECRUITING
Stoke-on-trent
Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust
RECRUITING
Sutton
Torbay and South Devon NHS Foundation Trust
RECRUITING
Torquay
New Cross Hospital
RECRUITING
Wolverhampton
Contact Information
Primary
BioNTech clinical trials patient information
patients@biontech.de
+49 6131 9084
Time Frame
Start Date: 2025-02-03
Estimated Completion Date: 2029-03
Participants
Target number of participants: 621
Treatments
Active_comparator: Stage 1 Control Arm - Atezolizumab + Etoposide + Carboplatin
Experimental: Stage 1 Treatment Arm 1 - Pumitamig Dose 1 + Etoposide + Carboplatin
Experimental: Stage 1 Treatment Arm 2 - Pumitamig Dose 2 + Etoposide + Carboplatin
Active_comparator: Stage 2 Control Arm - Atezolizumab + Etoposide + Carboplatin
Experimental: Stage 2 Treatment Arm - Pumitamig Dose 3 + Etoposide + Carboplatin
Related Therapeutic Areas
Sponsors
Collaborators: Bristol-Myers Squibb
Leads: BioNTech SE

This content was sourced from clinicaltrials.gov

Similar Clinical Trials