Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer
Start Date
1/7/2025
Completion Date
3/1/2030
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.
Detailed Description
Each substudy contains a Phase 2 part followed by a Phase 3 part. Participants will be randomized to one of two dose levels of pumitamig (BNT327) plus chemotherapy for the Phase 2 part of each substudy. For the Phase 3 part of both substudies, an independent data monitoring committee (IDMC) and a blinded Independent Central Review (BICR) will be established. The IDMC will provide independent review of the data during the study as needed and the BICR will review all available tumor assessment scans for all treated participants. The planned study duration per study participant is up to 64 months.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Pumitamig
Pembrolizumab
Carboplatin
Pemetrexed
Paclitaxel
Conditions
Locations
Birmingham Hematology and Oncology Associates LLC d/b/a Alabama Oncology
Birmingham, Alabama 35223
United States
Alaska Oncology and Hematology, LLC
Anchorage, Alaska 99508
United States
John Muir Clinical Research Center
Concord, California 94520
United States
University Of California - San Diego Moores Cancer Center
La Jolla, California 92093
United States
Clermont Oncology Center
Clermont, Florida 34711
United States
Mid Florida Cancer Centers
Orange City, Florida 32763
United States
Cleveland Clinic Florida - Martin North Hospital
Stuart, Florida 34994
United States
H. Lee Moffit Cancer center and research institute
Tampa, Florida 33612
United States
Cleveland Clinic Weston Hospital
Weston, Florida 33331
United States
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana 46845
United States
Physicians Clinic of Iowa
Cedar Rapids, Iowa 52401-2112
United States
Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United States
Baptist Health Hardin
Elizabethtown, Kentucky 42701
United States
Frederick Health Hospital- James M Stockman Cancer Institute
Frederick, Maryland 21704
United States
Missouri Cancer Associates
Columbia, Missouri 65201
United States
SSM Health Cancer Care - St. Clare
Fenton, Missouri 63026
United States
Mary Lanning Healthcare (MLH) - Morrison Cancer Center (MCC)
Hastings, Nebraska 68901-4470
United States
Astera Cancer Care
East Brunswick, New Jersey 08816
United States
Summit Medical Group PA
Florham Park, New Jersey 07932
United States
The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion
Paramus, New Jersey 07652
United States
Suny-Stony Brook University Cancer Center
Stony Brook, New York 11794-9446
United States
White Plains Hospital
White Plains, New York 10601
United States
Fletcher Hospital, Inc. dba AdventHealth Hendersonville
Hendersonville, North Carolina 28792
United States
Gabrail Cancer Center Research
Canton, Ohio 44718
United States
The Christ Hospital Cancer Center
Cincinnati, Ohio 45219
United States
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United States
The Cleveland Clinic Cancer Center At Fairview Hospital, Moll Pavilion
Cleveland, Ohio 44111
United States
Cleveland Clinic
Cleveland, Ohio 44195-0001
United States
Dayton Physicians Network
Dayton, Ohio 45415
United States
Kettering Medical Center
Kettering, Ohio 45429
United States
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio 44124
United States
INTEGRIS Cancer Institute of Oklahoma
Oklahoma City, Oklahoma 73109
United States
University of Tennessee Medical Center
Knoxville, Tennessee 37920
United States
Baptist Cancer Center
Memphis, Tennessee 38120
United States
Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Millennium Research and Clinical Development, LLC
Houston, Texas 77090
United States
Virginia Cancer Specialists - Arlington
Arlington, Virginia 22201
United States
Virginia Cancer Specialists
Fairfax, Virginia 22031
United States
VCU Massey Cancer Center
Richmond, Virginia 23298
United States
Shenandoah Oncology
Winchester, Virginia 22601
United States
Cancer Research SA (CRSA)
Adelaide, 5000
Australia
Royal Adelaide Hospital
Adelaide, 5000
Australia
Flinders Medical Centre
Bedford Park, 5042
Australia
Cairns Hospital
Cairns, 4870
Australia
Dubbo Hospital
Dubbo, 2830
Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, 3199
Australia
Icon Cancer Centre Kurralta Park
Kurralta Park, 5037
Australia
Peter MacCallum Cancer Centre
Melbourne, 3000
Australia
Monash University - Monash Health -Monash Medical Centre
Melbourne, 3168
Australia
Central West Cancer Care Centre
Orange, 2800
Australia
Western Health Sunshine Hospital
St Albans, 3021
Australia
ICON Cancer Care - Townsville
Townsville, 4812
Australia
Cancer Care Wollongong Pty Limited
Wollongong, 2500
Australia
Universitair Ziekenhuis Leuven
Leuven, 3000
Belgium
CHU HELORA, Hopital de Mons - Site Kennedy
Mons, 7000
Belgium
VITAZ
Sint-Niklaas, 9100
Belgium
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base de Sao Jose do Rio Preto
São José do Vale do Rio Preto, 15090-000
Brazil
Complex Oncological Center Ruse Ltd
Rousse, 7000
Bulgaria
Affiliated Hospital of Hebei University
Baoding, 071000
China
Beijing Friendship Hospital, Capital Medical University
Beijing, 100050
China
Beijing Hospital
Beijing, 100730
China
Peking Union Medical College Hospital
Beijing, 100730
China
Jilin Cancer Hospital
Changchun, 130000
China
Zhejiang Medical University, Zhejiang Cancer Hospital
Hangzhou, 310022
China
Shandong University - Jinan Central Hospital
Jinan, 250013
China
Yunnan Provincial Cancer Hospital
Kunming, 650118
China
Jiangsu Peoples Hospital
Nanjing, 210029
China
Shanghai Chest Hospital
Shanghai, 200030
China
Cancer Hospital of Shantou University Medical College
Shantou, 515041
China
The First Affiliated Hospital of Soochow University
Suzhou, 215006
China
Chongqing University Three Gorges Hospital
Wanzhou, 404000
China
Zhongnan Hospital of Wuhan University
Wuhan, 430071
China
Northern Jiangsu Peoples Hospital (NJPH)
Yangzhou, 225001
China
Taizhou Hospital of Zhejiang Province
Zhejiang, 317000
China
Institut de Cancerologie de l'Ouest Paul Papin
Angers, 49055
France
Centre Hospitalier Universitaire d'Angers (CHU Angers)
Angers, 49933
France
Centre Hospitalier de la Cote Basque
Bayonne, 64109
France
Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre
Bordeaux, 33000
France
Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, 33076
France
Hospices Civils de Lyon - Hopital Louis Pradel
Bron, 69500
France
CHU Caen Normandie
Caen, 14033
France
Centre Francois Baclesse
Caen, 14076
France
Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de ressources et de competences pour la mucoviscidose (C.R.C.M.)
Créteil, 94010
France
Centre Hospitalier Universitaire De Grenoble- Hopital Albert Michallon
La Tronche, 38700
France
Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse
Lyon, 69004
France
Institut Paoli-Calmettes
Marseille, 13009
France
GHRMSA Hopital Emile Muller
Mulhouse, 68100
France
Institut Curie - Centre de Recherche
Paris, 75005
France
CIC Cochin Pasteur, Hopital Cochin
Paris, 75014
France
Hopital Lyon Sud
Pierre-Bénite, 69310
France
CHU de Rennes, Hopital de Pontchaillou
Rennes, 35033
France
Institut de Cancerologie de l'Ouest (ICO)- CRLCC Rene Gauducheau
Saint-Herblain, 44805
France
Centre Regional Lutte Contre Le Cancer Paul Strauss
Strasbourg, 67200
France
Hopital Foch
Suresnes, 92151
France
Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre
Toulon, 83000
France
Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP
Villejuif, 94805
France
High Technology Hospital Medcenter LTD
Batumi, 6000
Georgia
LLC Todua Clinic
Tbilisi, 0112
Georgia
LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi, 0144
Georgia
New Hospitals
Tbilisi, 0162
Georgia
Cancer Research Centre
Tbilisi, 0179
Georgia
Uniklinik RWTH Aachen Medizinische Klinik IV
Aachen, 52074
Germany
Evangelische Lungenklinik Berlin
Berlin, 13125
Germany
Klinikum Chemnitz gGmbH
Chemnitz, 09116
Germany
Universitätsklinikum Erlangen
Erlangen, 91054
Germany
Klinikum Esslingen GmbH
Esslingen am Neckar, 73730
Germany
Asklepios Fachkliniken Muenchen Gauting
Gauting, 82131
Germany
SRH Wald-Kliniken Gera GmbH
Gera, 07548
Germany
Thoraxklinik-Heidelberg Ggmbh
Heidelberg, 69126
Germany
Lungenfachklinik Immenhausen - Pneumologische Lehrklinik der Universitaet Goettingen
Immenhausen, 34376
Germany
University Medical Center of Johannes Gutenberg-University Mainz
Mainz, 55131
Germany
Staedtisches Klinikum Muenchen Bogenhausen
München, 81925
Germany
MVZ for oncology and hematology Rhein-Kreis Neuss GmbH
Neuss, 41462
Germany
Onkologische Tagesklinik Remscheid
Remscheid, 42853
Germany
Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling
Wesseling, 50389
Germany
Helios Klinikum Wuppertal-Universitaet Witten-Herdecke
Wuppertal, 42883
Germany
Orszagos Onkologiai Intezet (National Institute of Oncology)
Budapest, 1122
Hungary
Edelenyi Koch Robert Korhaz es Rendelointezet
Edelény, 3780
Hungary
Azienda Ospedaliera San Giuseppe Moscati
Avellino, 83100
Italy
Centro di Riferimento Oncologico
Aviano, 33081
Italy
Azienda Ospedaliero Universitaria Di Bologna Policlinico S. Orsola Malpighi
Bologna, 40138
Italy
Azienda Ospedaliero - Universitaria di Ferrara
Cona, 44124
Italy
Azienda Socio Sanitaria Territoriale di Cremona (ASST Cremona)
Cremona, 26100
Italy
Ospedale San Luca
Lucca, 55100
Italy
IRCCS Istituto Romagnolo per lo studio dei Tumori Dino Amadori (IRST)
Meldola, 47014
Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
Milan, 20132
Italy
UOC Oncoematologia AOU Luigi Vanvitelli
Naples, 80131
Italy
Casa Di Cura Polispecialistica Dott Pederzoli
Peschiera del Garda, 37019
Italy
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, 00128
Italy
Istituti di Ricovero e Cura A Carattere Scientifico (IRCCS) - Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE)
Roma, 00144
Italy
Fondazione Ospedale Isola Tiberina - Gemelli Isola
Rome, 00186
Italy
Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
Siena, 53100
Italy
Ageo Central General Hospital
Ageo, 362-8588
Japan
Hyogo Cancer Center
Akashi, 673-8558
Japan
Tokyo Metropolitan Komagome Hospital
Bunkyō City, 113-8677
Japan
National Hospital Organization Himeji Medical Center
Himeji, 670-8520
Japan
National Hospital Organization Iwakuni Clinical Center
Iwakuni, 740-8510
Japan
Shonan Kamakura General Hospital
Kanagawa, 247-8533
Japan
Ishikawa Prefectural Central Hospital
Kanazawa, 920-8530
Japan
Matsusaka Municipal Hospital
Matsusaka, 515-8544
Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, 791-0280
Japan
National Hospital Organization Tokyo Medical Center
Meguro City, 152-8902
Japan
Iwate Medical University Hospital
Morioka, 028-3695
Japan
Shizuoka Cancer Center
Nagaizumi-chō, 411-8777
Japan
Japan Community Healthcare Organization Chukyo Hospital
Nagoya, 457-8510
Japan
National Hospital Organization Nagoya Medical Center
Nagoya, 460-0001
Japan
Nagoya University Hospital
Nagoya, 466-8560
Japan
Niigata Cancer Center Hospital
Niigata, 951-8566
Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Osaka, 541-8567
Japan
NHO Kinki Chuo Chest Medical Center
Sakai, 591-8555
Japan
Sapporo Minamisanjo Hospital
Sapporo, 060-0063
Japan
Sendai Kousei Hospital
Sendai, 981-0914
Japan
Shibukawa Medical Center
Shibukawa, 377-0280
Japan
Wakayama Medical University Hospital
Wakayama, 641-8510
Japan
Yokohama Municipal Citizen's Hospital
Yokohama, 221-0855
Japan
Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i Radioterapii
Gdansk, 80-211
Poland
Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie
Koszalin, 75-581
Poland
FutureMeds Krakow
Krakow, 31-501
Poland
Instytut MSF Sp. z o.o.
Lodz, 90-302
Poland
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
Lublin, 20-954
Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii
Poznan, 60-101
Poland
NZOZ Medpolonia Sp. Z o.o.
Poznan, 60-693
Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
Przemyśl, 37-700
Poland
Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
Wroclaw, 53-413
Poland
Coltea Clinical Hospital
Bucharest, 030171
Romania
SC Gral Medical SRL
Bucharest, 031424
Romania
Cardiomed
Cluj-Napoca, 400015
Romania
S.C. Medisprof S.R.L, Oncologie medicala
Cluj-Napoca, 400641
Romania
Radiotherapy Center Cluj
Cluj-Napoca, 407280
Romania
Onco Clinic Consult SA
Craiova, 200094
Romania
Centrul de Oncologie Sf. Nectarie S.R.L (Sf Nectarie Oncology Center)
Craiova, 200542
Romania
Centrul de Oncologie Euroclinic srl
Iași, 700106
Romania
Ovidius Clinical Hospital
Ovidiu, 905900
Romania
Municipal Hospital Ploiesti
Ploieşti, 100337
Romania
Oncomed
Timișoara, 300239
Romania
Chungbuk National University Hospital
Cheongju-si, 28644
South Korea
Chungnam National University Hospital (CNUH)
Daejeon, 35015
South Korea
National Cancer Center
Goyang-si, 10408
South Korea
Gachon University Gil Medical Center
Incheon, 21565
South Korea
Gyeongsang National University Hospital (GNUH)
Jinju, 52727
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722
South Korea
Asan Medical Center (AMC)
Seoul, 05505
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Korea University Guro Hospital
Seoul, 08308
South Korea
The Catholic University Of Korea, St. Vincent's Hospital
Suwon, 16247
South Korea
Ajou University Hospital
Suwon, 16499
South Korea
CHUAC Hospital Teresa Herrera
A Coruña, 15006
Spain
Hospital Universitario de Badajoz
Badajoz, 6006
Spain
Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol
Badalona, 08916
Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Spain
Instituto Catalan de Oncologia - Hospital Duran i Reynals
Barcelona, 8908
Spain
Consorcio Hospitalario Provincial de Castellón
Castellon, 12002
Spain
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas de Gran Canaria, 35016
Spain
Hospital Universitario De Leon
León, 24080
Spain
Hospital Universitari de Lleida Arnau de Villanova
Lleida, 25198
Spain
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid, 28007
Spain
Clinica MD Anderson International
Madrid, 28033
Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda, 28222
Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, 38320
Spain
Hospital Universitario Virgen del Rocio
Seville, 41013
Spain
Hospital Universitario Nuestra Senora De Valme
Seville, 41014
Spain
Fundacion Instituto Valenciano de Oncologia
Valencia, 46009
Spain
Hospital General Universitario De Valencia
Valencia, 46014
Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, 46026
Spain
Hospital Alvaro Cunqueiro
Vigo, 36312
Spain
Hospital Universitario Miguel Servet de Zaragoza
Zaragoza, 50009
Spain
Kantonspital Baden
Baden, 5404
Switzerland
Centre Hospitalier Universitaire Vaudois Lausanne (CHUV) - Centre de transplantation d'organes (CTO)
Lausanne, 1011
Switzerland
Faculty of Medicine Vajira Hospital, Navamindradhiraj University
Bangkok, 10300
Thailand
Chulalongkorn University
Bangkok, 10330
Thailand
Chiangrai Prachanukroh Hospital
Chiang Rai, 57000
Thailand
Lampang Cancer Hospital
Lampang, 52000
Thailand
HRH Princess MahaChakri Sirindhorn Medical Center - Srinakharinwirot University
Nakhon Nayok, 26120
Thailand
Rajavithi Hospital
Ratchathewi, 10400
Thailand
Baskent Universitesi Tip Fakultesi Adana Hastanesi
Adana, 1120
Turkey (Türkiye)
Adana City Training and Research Hospital
Adana, 1370
Turkey (Türkiye)
Gulhane Training and Research Hospital
Ankara, 06010
Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, 06200
Turkey (Türkiye)
Hacettepe University Medicine Faculty
Ankara, 06230
Turkey (Türkiye)
Memorial Ankara Hospital
Ankara, 06520
Turkey (Türkiye)
Liv Hospital Ankara
Ankara, 06680
Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, 06800
Turkey (Türkiye)
Akdeniz University Hospital
Antalya, 7985
Turkey (Türkiye)
Dicle University Faculty of Medicine Hospital
Diyarbakır, 21280
Turkey (Türkiye)
Gaziantep Sanko University Medical Faculty
Gaziantep, 36020
Turkey (Türkiye)
Bezmialem Foundation University Medical Faculty
Istanbul, 34093
Turkey (Türkiye)
Istinye University Bahcesehir Liv Hospital
Istanbul, 34517
Turkey (Türkiye)
Yeditepe University Kosuyolu Hospital
Istanbul, 34718
Turkey (Türkiye)
Medical Point Izmir Hospital
Izmir, 35325
Turkey (Türkiye)
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Kadıköy, 34722
Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, 41380
Turkey (Türkiye)
Necmettin Erbakan University Meram Medical Faculty
Konya, 42080
Turkey (Türkiye)
Medical Park Florya Hospital
Küçükçekmece, 34295
Turkey (Türkiye)
Medicalpark Ordu Hospital
Ordu, 34752
Turkey (Türkiye)
Karadeniz Technical University Faculty of Medicine
Ortahisar, 61080
Turkey (Türkiye)
Sakarya University - Faculty of Medicine
Sakarya, 54290
Turkey (Türkiye)
Ondokuz Mayis University Health Practice and Research Hospital
Samsun, 55280
Turkey (Türkiye)
Acibadem Adana Hospital
Seyhan, 01130
Turkey (Türkiye)
Medical Park Seyhan Hospital
Seyhan, 01170
Turkey (Türkiye)
Mersin City Training and Research Hospital
Toroslar, 33240
Turkey (Türkiye)
Gazi University Faculty of Medicine
Yenimahalle, 06560
Turkey (Türkiye)
Koc Universitesi Hastanesi (Koc University Hospital)
Zeytinburnu, 34010
Turkey (Türkiye)
Royal United Hospital, Bath - Royal United Hospitals Bath NHS Foundation Trust
Bath, BA1 3NG
United Kingdom
Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust
Brighton, BN2 5BE
United Kingdom
Velindre NHS Trust, Velindre Cancer Centre
Cardiff, CF14 2TL
United Kingdom
Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust
Chelsea, SW3 6JJ
United Kingdom
Hull University Teaching Hospitals NHS Trust
Cottingham, HU16 5JQ
United Kingdom
Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board
Glasgow, G12 0YN
United Kingdom
Clatterbridge Cancer Centre
Liverpool, L7 8YA
United Kingdom
University College Hospital
London, NW2 1PG
United Kingdom
Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust
London, SM2 5PT
United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX
United Kingdom
Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, NR4 7UY
United Kingdom
Cancer And Haematology Centre-The Churchill Hospital-Oxford University Hospitals
Oxford, OX3 7LJ
United Kingdom
Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
Preston, PR2 9HT
United Kingdom
Weston Park Hospital - Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2SJ
United Kingdom
Southampton General Hospital
Southampton, SO16 6YD
United Kingdom
Musgrove Park Hospital-Taunton & Somerset NHS Foundation Trust
Taunton, TA1 5DA
United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP
United Kingdom