Lung Cancer Clinical Trials

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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 (206) 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 systemic treatment naive, 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, 9th edition.

• 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
California
John Muir Clinical Research Center
RECRUITING
Concord
University Of California - San Diego Moores Cancer Center
RECRUITING
La Jolla
Florida
Clermont Oncology Center
RECRUITING
Clermont
Cleveland Clinic Florida - Martin North Hospital
RECRUITING
Stuart
H. Lee Moffit Cancer center and research institute
RECRUITING
Tampa
Cleveland Clinic Weston Hospital
RECRUITING
Weston
Iowa
Physicians Clinic of Iowa
RECRUITING
Cedar Rapids
Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics
RECRUITING
Iowa City
Kentucky
Baptist Health Hardin
RECRUITING
Elizabethtown
Maryland
Frederick Health Hospital- James M Stockman Cancer Institute
RECRUITING
Frederick
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
Summit Medical Group PA
RECRUITING
Florham Park
The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion
RECRUITING
Paramus
New York
Suny-Stony Brook University Cancer Center
RECRUITING
Stony Brook
White Plains Hospital
RECRUITING
White Plains
Ohio
Gabrail Cancer Center Research
RECRUITING
Canton
The Christ Hospital Cancer Center
RECRUITING
Cincinnati
University of Cincinnati Medical Center
RECRUITING
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
The Cleveland Clinic Cancer Center At Fairview Hospital, Moll Pavilion
RECRUITING
Cleveland
Kettering Medical Center
RECRUITING
Kettering
Cleveland Clinic - Hillcrest Hospital
RECRUITING
Mayfield Heights
Oklahoma
INTEGRIS Cancer Institute of Oklahoma
RECRUITING
Oklahoma City
Tennessee
University of Tennessee Medical Center
RECRUITING
Knoxville
Baptist Cancer Center
RECRUITING
Memphis
Texas
Millennium Research and Clinical Development, LLC
ACTIVE_NOT_RECRUITING
Houston
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
VCU Massey Cancer Center
RECRUITING
Richmond
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
Monash University - Monash Health -Monash Medical Centre
RECRUITING
Melbourne
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Central West Cancer Care Centre
RECRUITING
Orange
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
VITAZ
RECRUITING
Sint-niklaas
China
Affiliated Hospital of Hebei University
RECRUITING
Baoding
Beijing Friendship Hospital, Capital Medical University
RECRUITING
Beijing
Jilin Cancer Hospital
RECRUITING
Changchun
Zhejiang Medical University, Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Shandong University - Jinan Central Hospital
RECRUITING
Jinan
Yunnan Provincial Cancer Hospital
RECRUITING
Kunming
Jiangsu Peoples Hospital
RECRUITING
Nanjing
Shanghai Chest Hospital
RECRUITING
Shanghai
Cancer Hospital of Shantou University Medical College
RECRUITING
Shantou
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Chongqing University Three Gorges Hospital
RECRUITING
Wanzhou
Zhongnan Hospital of Wuhan University
RECRUITING
Wuhan
Northern Jiangsu Peoples Hospital (NJPH)
RECRUITING
Yangzhou
Taizhou Hospital of Zhejiang Province
RECRUITING
Zhejiang
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 Paoli-Calmettes
RECRUITING
Marseille
Institut Curie - Centre de Recherche
RECRUITING
Paris
CHU de Rennes, Hopital de Pontchaillou
RECRUITING
Rennes
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
Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP
RECRUITING
Villejuif
Germany
Uniklinik RWTH Aachen Medizinische Klinik IV
RECRUITING
Aachen
Evangelische Lungenklinik Berlin
RECRUITING
Berlin
Klinikum Chemnitz gGmbH
RECRUITING
Chemnitz
Universitätsklinikum Erlangen
RECRUITING
Erlangen
Klinikum Esslingen GmbH
RECRUITING
Esslingen Am Neckar
Asklepios Fachkliniken Muenchen Gauting
RECRUITING
Gauting
SRH Wald-Kliniken Gera GmbH
RECRUITING
Gera
Thoraxklinik-Heidelberg Ggmbh
RECRUITING
Heidelberg
Lungenfachklinik Immenhausen - Pneumologische Lehrklinik der Universitaet Goettingen
RECRUITING
Immenhausen
University Medical Center of Johannes Gutenberg-University Mainz
RECRUITING
Mainz
MVZ for oncology and hematology Rhein-Kreis Neuss GmbH
RECRUITING
Neuss
Onkologische Tagesklinik Remscheid
RECRUITING
Remscheid
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
Azienda Ospedaliero Universitaria Di Bologna Policlinico S. Orsola Malpighi
RECRUITING
Bologna
Azienda Socio Sanitaria Territoriale di Cremona (ASST Cremona)
RECRUITING
Cremona
Ospedale San Luca
RECRUITING
Lucca
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
UOC Oncoematologia AOU Luigi Vanvitelli
RECRUITING
Naples
Casa Di Cura Polispecialistica Dott Pederzoli
RECRUITING
Peschiera Del Garda
Fondazione Policlinico Universitario Campus Bio-Medico
RECRUITING
Roma
Istituti di Ricovero e Cura A Carattere Scientifico (IRCCS) - Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE)
RECRUITING
Roma
Fondazione Ospedale Isola Tiberina - Gemelli Isola
RECRUITING
Rome
Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
RECRUITING
Siena
Japan
Ageo Central General Hospital
RECRUITING
Ageo
Tokyo Metropolitan Komagome Hospital
RECRUITING
Bunkyō City
National Hospital Organization Himeji Medical Center
RECRUITING
Himeji
National Hospital Organization Iwakuni Clinical Center
RECRUITING
Iwakuni
Matsusaka Municipal Hospital
RECRUITING
Matsusaka
National Hospital Organization Shikoku Cancer Center
RECRUITING
Matsuyama
National Hospital Organization Tokyo Medical Center
RECRUITING
Meguro City
Iwate Medical University Hospital
RECRUITING
Morioka
Shizuoka Cancer Center
RECRUITING
Nagaizumi-chō
Nagoya University Hospital
RECRUITING
Nagoya
National Hospital Organization Nagoya Medical Center
RECRUITING
Nagoya
Niigata Cancer Center Hospital
RECRUITING
Niigata
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
RECRUITING
Osaka
NHO Kinki Chuo Chest Medical Center
RECRUITING
Sakai
Sendai Kousei Hospital
RECRUITING
Sendai
Wakayama Medical University Hospital
RECRUITING
Wakayama
Poland
Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i Radioterapii
RECRUITING
Gdansk
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
Municipal Hospital Ploiesti
RECRUITING
Ploieşti
Oncomed
RECRUITING
Timișoara
Spain
Hospital Universitario de Badajoz
RECRUITING
Badajoz
Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol
RECRUITING
Badalona
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
Consorcio Hospitalario Provincial de Castellón
RECRUITING
Castellon
Complejo Hospitalario Universitario Insular Materno Infantil
RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario De Leon
RECRUITING
León
Hospital Universitari de Lleida Arnau de Villanova
RECRUITING
Lleida
Clinica MD Anderson International
RECRUITING
Madrid
Hospital General Universitario Gregorio Maranon (HGUGM)
RECRUITING
Madrid
Hospital Universitario Fundacion Jimenez Diaz
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro de Majadahonda
RECRUITING
Majadahonda
Hospital Universitario de Canarias
RECRUITING
Santa Cruz De Tenerife
Hospital Universitario Nuestra Senora De Valme
RECRUITING
Seville
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Fundacion Instituto Valenciano de Oncologia
RECRUITING
Valencia
Hospital General Universitario De Valencia
RECRUITING
Valencia
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
RECRUITING
Valencia
Hospital Alvaro Cunqueiro
RECRUITING
Vigo
Hospital Universitario Miguel Servet de Zaragoza
RECRUITING
Zaragoza
Thailand
Chulalongkorn University
RECRUITING
Bangkok
Faculty of Medicine Vajira Hospital, Navamindradhiraj University
RECRUITING
Bangkok
Chiangrai Prachanukroh Hospital
RECRUITING
Chiang Rai
Lampang Cancer Hospital
RECRUITING
Lampang
HRH Princess MahaChakri Sirindhorn Medical Center - Srinakharinwirot University
RECRUITING
Nakhon Nayok
Rajavithi Hospital
RECRUITING
Ratchathewi
Turkey
Adana City Training and Research Hospital
RECRUITING
Adana
Baskent Universitesi Tip Fakultesi Adana Hastanesi
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
Dicle University Faculty of Medicine Hospital
RECRUITING
Diyarbakır
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
Karadeniz Technical University Faculty of Medicine
RECRUITING
Ortahisar
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
Mersin City Training and Research Hospital
RECRUITING
Toroslar
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
Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust
RECRUITING
Chelsea
Hull University Teaching Hospitals NHS Trust
RECRUITING
Cottingham
Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board
RECRUITING
Glasgow
Clatterbridge Cancer Centre
RECRUITING
Liverpool
Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust
RECRUITING
London
University College Hospital
RECRUITING
London
The Christie NHS Foundation Trust
RECRUITING
Manchester
Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust
RECRUITING
Norwich
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: 2030-03
Participants
Target number of participants: 1260
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 dose 3 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 dose 3 for Phase 3
Active_comparator: Substudy B Phase 3 - Pembrolizumab + Carboplatin + Paclitaxel
Sponsors
Collaborators: Bristol-Myers Squibb
Leads: BioNTech SE

This content was sourced from clinicaltrials.gov