A Phase II/III, Multisite, Randomized Master Protocol for a Global Trial of BNT327 in Combination With Chemotherapy and Other Investigational Agents in First-line Non-small Cell Lung Cancer

Status: Recruiting
Location: See all (110) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC). This study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice for standard-of-care and type of NSCLC.

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

• Have histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system, 8th edition without actionable epidermal growth factor receptor mutation or anaplastic lymphoma kinase (ALK) rearrangement.

• 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 performance status of 0 or 1.

• Adequate organ function.

Locations
United States
Alaska
Alaska Oncology and Hematology, LLC
RECRUITING
Anchorage
Florida
Clermont Oncology Center
RECRUITING
Clermont
H. Lee Moffit Cancer center and research institute
RECRUITING
Tampa
Iowa
Physicians Clinic of Iowa
RECRUITING
Cedar Rapids
Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics
RECRUITING
Iowa City
Kentucky
Baptist Health
RECRUITING
Lexington
Missouri
SSM Health Cancer Care - St. Clare
RECRUITING
Fenton
North Carolina
Fletcher Hospital, Inc. dba AdventHealth Hendersonville
RECRUITING
Hendersonville
Nebraska
Mary Lanning Healthcare (MLH) - Morrison Cancer Center (MCC)
RECRUITING
Hastings
New Jersey
Astera Cancer Care
RECRUITING
East Brunswick
The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion
RECRUITING
Paramus
New York
White Plains Hospital
RECRUITING
White Plains
Ohio
University of Cincinnati Medical Center
RECRUITING
Cincinnati
Tennessee
University of Tennessee Medical Center
RECRUITING
Knoxville
Baptist Cancer Center
RECRUITING
Memphis
Texas
Millennium Research and Clinical Development, LLC
ACTIVE_NOT_RECRUITING
Houston
Other Locations
Australia
Cancer Research SA (CRSA)
RECRUITING
Adelaide
Royal Adelaide Hospital
RECRUITING
Adelaide
Flinders Medical Centre
RECRUITING
Bedford Park
Cairns Hospital
RECRUITING
Cairns
Dubbo Hospital
RECRUITING
Dubbo
Peninsula & South Eastern Haematology and Oncology Group
RECRUITING
Frankston
Icon Cancer Centre Kurralta Park
RECRUITING
Kurralta Park
Western Health Sunshine Hospital
RECRUITING
St Albans
ICON Cancer Care - Townsville
RECRUITING
Townsville
Cancer Care Wollongong Pty Limited
RECRUITING
Wollongong
Belgium
Universitair Ziekenhuis Leuven
RECRUITING
Leuven
CHU HELORA, Hopital de Mons - Site Kennedy
RECRUITING
Mons
China
Shandong University - Jinan Central Hospital
RECRUITING
Jinan
Shanghai Chest Hospital
RECRUITING
Shanghai
Cancer Hospital of Shantou University Medical College
RECRUITING
Shantou
France
Centre Hospitalier Universitaire d'Angers (CHU Angers)
RECRUITING
Angers
Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
RECRUITING
Bordeaux
Centre Francois Baclesse
RECRUITING
Caen
CHU Caen Normandie
RECRUITING
Caen
Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de ressources et de competences pour la mucoviscidose (C.R.C.M.)
RECRUITING
Créteil
Institut de Cancerologie de l'Ouest (ICO)- CRLCC Rene Gauducheau
RECRUITING
Saint-herblain
Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre
RECRUITING
Toulon
Germany
Klinikum Esslingen GmbH
RECRUITING
Esslingen Am Neckar
Asklepios Fachkliniken Muenchen Gauting
RECRUITING
Gauting
Lungenfachklinik Immenhausen - Pneumologische Lehrklinik der Universitaet Goettingen
RECRUITING
Immenhausen
MVZ for oncology and hematology Rhein-Kreis Neuss GmbH
RECRUITING
Neuss
Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling
RECRUITING
Wesseling
Helios Klinikum Wuppertal-Universitaet Witten-Herdecke
RECRUITING
Wuppertal
Italy
Azienda Ospedaliera San Giuseppe Moscati
RECRUITING
Avellino
Centro di Riferimento Oncologico
RECRUITING
Aviano
IRCCS Istituto Romagnolo per lo studio dei Tumori Dino Amadori (IRST)
RECRUITING
Meldola
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
RECRUITING
Milan
Casa Di Cura Polispecialistica Dott Pederzoli
RECRUITING
Peschiera Del Garda
Fondazione Policlinico Universitario Campus Bio-Medico
RECRUITING
Roma
Fondazione Ospedale Isola Tiberina - Gemelli Isola
RECRUITING
Rome
Poland
Instytut MSF Sp. z o.o.
RECRUITING
Lodz
NZOZ Medpolonia Sp. Z o.o.
RECRUITING
Poznan
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
RECRUITING
Przemyśl
Republic of Korea
Chungbuk National University Hospital
RECRUITING
Cheongju-si
Chungnam National University Hospital (CNUH)
RECRUITING
Daejeon
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
Romania
Coltea Clinical Hospital
RECRUITING
Bucharest
SC Gral Medical SRL
RECRUITING
Bucharest
Cardiomed
RECRUITING
Cluj-napoca
Radiotherapy Center Cluj
RECRUITING
Cluj-napoca
S.C. Medisprof S.R.L, Oncologie medicala
RECRUITING
Cluj-napoca
Centrul de Oncologie Sf. Nectarie S.R.L (Sf Nectarie Oncology Center)
RECRUITING
Craiova
Onco Clinic Consult SA
RECRUITING
Craiova
Ovidius Clinical Hospital
RECRUITING
Ovidiu
Oncomed
RECRUITING
Timișoara
Spain
Consorcio Hospitalario Provincial de Castellón
RECRUITING
Castellon
Hospital Universitari de Lleida Arnau de Villanova
RECRUITING
Lleida
Hospital Universitario Nuestra Senora De Valme
RECRUITING
Seville
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Hospital Universitario Miguel Servet de Zaragoza
RECRUITING
Zaragoza
Turkey
Adana City Training and Research Hospital
RECRUITING
Adana
Ankara Bilkent City Hospital
RECRUITING
Ankara
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
RECRUITING
Ankara
Gulhane Training and Research Hospital
RECRUITING
Ankara
Hacettepe University Medicine Faculty
RECRUITING
Ankara
Liv Hospital Ankara
RECRUITING
Ankara
Memorial Ankara Hospital
RECRUITING
Ankara
Akdeniz University Hospital
RECRUITING
Antalya
Gaziantep Sanko University Medical Faculty
RECRUITING
Gaziantep
Bezmialem Foundation University Medical Faculty
RECRUITING
Istanbul
Istinye University Bahcesehir Liv Hospital
RECRUITING
Istanbul
Yeditepe University Kosuyolu Hospital
RECRUITING
Istanbul
Medical Point Izmir Hospital
RECRUITING
Izmir
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
RECRUITING
Kadıköy
Kocaeli Universitesi Tip Fakultesi
RECRUITING
Kocaeli
Medical Park Florya Hospital
RECRUITING
Küçükçekmece
Sakarya University - Faculty of Medicine
RECRUITING
Sakarya
Ondokuz Mayis University Health Practice and Research Hospital
RECRUITING
Samsun
Acibadem Adana Hospital
RECRUITING
Seyhan
Medical Park Seyhan Hospital
RECRUITING
Seyhan
Gazi University Faculty of Medicine
RECRUITING
Yenimahalle
Koc Universitesi Hastanesi (Koc University Hospital)
RECRUITING
Zeytinburnu
United Kingdom
Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust
RECRUITING
Brighton
Velindre NHS Trust, Velindre Cancer Centre
RECRUITING
Cardiff
Hull University Teaching Hospitals NHS Trust
RECRUITING
Cottingham
University College Hospital
RECRUITING
London
The Christie NHS Foundation Trust
RECRUITING
Manchester
Cancer And Haematology Centre-The Churchill Hospital-Oxford University Hospitals
RECRUITING
Oxford
Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
RECRUITING
Preston
Southampton General Hospital
RECRUITING
Southampton
New Cross Hospital
RECRUITING
Wolverhampton
Contact Information
Primary
BioNTech clinical trials patient information
patients@biontech.de
+49 6131 9084
Time Frame
Start Date: 2025-01-07
Estimated Completion Date: 2030-12
Participants
Target number of participants: 982
Treatments
Experimental: Substudy A Phase 2 - Pumitamig Dose 1 + Carboplatin + Pemetrexed
Experimental: Substudy A Phase 2 - Pumitamig Dose 2 + Carboplatin + Pemetrexed
Experimental: Substudy A Phase 3 - Pumitamig + Carboplatin + Pemetrexed
Pumitamig selected dose for Phase 3
Active_comparator: Substudy A Phase 3 - Pembrolizumab + Carboplatin + Pemetrexed
Experimental: Substudy B Phase 2 - Pumitamig Dose 1 + Carboplatin + Paclitaxel
Experimental: Substudy B Phase 2 - Pumitamig Dose 2 + Carboplatin + Paclitaxel
Experimental: Substudy B Phase 3 - Pumitamig + Carboplatin + Paclitaxel
Pumitamig selected dose for Phase 3
Active_comparator: Substudy B Phase 3 - Pembrolizumab + Carboplatin + Paclitaxel
Sponsors
Leads: BioNTech SE
Collaborators: Biotheus Inc.

This content was sourced from clinicaltrials.gov

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