RecruitingPhase 3NCT06712355

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

Sponsor

BioNTech SE

Enrollment

621 participants

Start Date

Feb 3, 2025

Study Type

INTERVENTIONAL

Conditions

Extensive-stage Small-cell Lung Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests the immunotherapy drug BNT327 (which targets both PD-L1 and VEGF) combined with standard chemotherapy as a first-line treatment for extensive-stage small-cell lung cancer (ES-SCLC), the most aggressive form of small-cell lung cancer. **You may be eligible if...** - You have confirmed extensive-stage small-cell lung cancer (Stage IV, or specific Stage III with certain features) - You have not received prior systemic treatment for ES-SCLC - If you had limited-stage SCLC treated before, at least 6 months must have passed since that treatment **You may NOT be eligible if...** - You have already received chemotherapy or immunotherapy for extensive-stage disease - Your prior limited-stage treatment was completed less than 6 months ago - Your general health or organ function does not meet protocol requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPumitamig

Intravenous infusion

DRUGAtezolizumab

Intravenous infusion

DRUGEtoposide

Intravenous infusion and capsules

DRUGCarboplatin (or cisplatin if carboplatin is not tolerated)

Intravenous infusion

Locations(138)

Clermont Oncology Center

Clermont, Florida, United States

Cancer Care Centers of Brevard, Inc

Palm Bay, Florida, United States

Illinois Cancer Specialists

Niles, Illinois, 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

Frederick Health Hospital- James M Stockman Cancer Institute

Frederick, Maryland, 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

Cleveland Clinic - Akron General Hematology & Oncology

Akron, Ohio, United States

Cleveland Clinic Mercy Hospital Cancer Center

Canton, Ohio, United States

The Christ Hospital Cancer Center

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

The Cleveland Clinic Cancer Center at Fairview Hospital, Moll Pavilion

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Kettering Medical Center

Kettering, Ohio, United States

Cleveland Clinic - Hillcrest Hospital

Mayfield Heights, Ohio, United States

St. Luke's Physician Group - St. Luke's Cancer Care Associates

Fountain Hill, Pennsylvania, 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

Texas Oncology Cancer Center

Sugar Land, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Hematology Oncology Associates of Fredericksburg, Inc.

Fredericksburg, Virginia, United States

Virginia Commonwealth University School of Medicine

Richmond, Virginia, United States

Shenandoah Oncology

Winchester, 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

Affiliated Hospital of Hebei University

Baoding, China

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Peking Union Medical College Hospital

Beijing, China

Beijing Chest Hospital,Capital Medical University

Beijing, China

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Zhejiang Medical University, Zhejiang Cancer Hospital

Hangzhou, China

Jiamusi Cancer Hospital

Jiamusi, China

Shandong University - Jinan Central Hospital

Jinan, China

Shandong Cancer Hospital and Institute

Jinan, China

Linyi Cancer Hospital

Linyi, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

Jiangsu Peoples Hospital

Nanjing, China

Guangxi Tumour Hospital

Nanning, China

Shanghai Chest Hospital

Shanghai, China

Fudan University - Shanghai Cancer Center (FUSCC)

Shanghai, China

Cancer Hospital of Shantou University Medical College

Shantou, China

The First Affiliated Hospital of Soochow University

Suzhou, China

Shanxi Provincial Tumor Hospital (Shanxi Oncology Hospital)

Taiyuan, China

Chongqing University Three Gorges Hospital

Wanzhou, China

The First Affiliated Hospital Of Wenzhou Medical University

Wenzhou, China

Zhongnan Hospital of Wuhan University

Wuhan, China

Xiangyang Central Hospital

Xiangyang, China

The First Affiliated Hospital of Henan Medical University

Xinxiang, China

Northern Jiangsu Peoples Hospital (NJPH)

Yangzhou, China

Taizhou Hospital of Zhejiang Province

Zhejiang, China

Evangelische Lungenklinik Berlin

Berlin, Germany

Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling

Bonn, Germany

SRH Wald-Kliniken Gera GmbH

Gera, Germany

LungenClinic Grosshansdorf GmbH

Großhansdorf, Germany

MVZ for oncology and hematology Rhein-Kreis Neuss GmbH

Neuss, Germany

Helios Klinikum Wuppertal-Universitaet Witten-Herdecke

Wuppertal, Germany

Tokyo Metropolitan Komagome Hospital

Bunkyō City, Japan

National Cancer Center Hospital

Chūōku, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

National Hospital Organization Himeji Medical Center

Himeji, Japan

National Hospital Organization Iwakuni Clinical Center

Iwakuni, Japan

Kurume University Hospital

Kurume, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, Japan

Sendai Kousei Hospital

Miyagi, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Okayama University Hospital

Okayama, Japan

Osaka Prefectural Hospital Organization Osaka International Cancer Institute

Osaka, Japan

NHO Kinki Chuo Chest Medical Center

Sakai, Japan

KOMED Roman Karaszewski I Wspolnicy Spolka Jawna

Konin, Poland

FutureMeds Krakow

Krakow, Poland

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu

Przemyśl, Poland

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

Hospital General Universitario Gregorio Maranon (HGUGM)

Madrid, Spain

Hospital Universitario Nuestra Senora De Valme

Seville, Spain

Hospital Clinico Universitario Lozano Blesa de Zaragoza

Zaragoza, Spain

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)

Trakya University Faculty of Medicine

Edirne, 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)

Ankara University Medical Faculty Hospital

Mamak, 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

Royal Devon and Exeter Hospital, Royal Devon University Healthcare NHS Foundation Trust

Exeter, United Kingdom

St James's University Hospital - Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Guy's Hospital - Guy's & St Thomas' NHS Foundation Trust

London, United Kingdom

Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust

Preston, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06712355

Related Trials

Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC

NCT065368686 locations

A Study of Valemetostat in Combination With Atezolizumab in People With Lung Cancer

NCT068076327 locations

Clinical Study on Using TCR to Predict the Effect of Tislelizumab + Chemotherapy in the First-line Treatment of ES-SCLC

NCT072440161 location

Study of Bevacizumab in Combination With Chemoimmunotherapy and Atezolizumab in Patients With Extensive Stage Small Cell Lung Cancer and Liver Metastases

NCT055883883 locations

Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan

NCT058744011 location