Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer
Start Date
2/3/2025
Completion Date
3/1/2029
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).
Detailed Description
There are two stages in this study: Stage 1 will have two treatment arms and one control arm, and Stage 2 will have a treatment arm and a control arm. The control arms in Stages 1 and 2 are the same. Each stage of the study consists of a screening period (up to 21 days), an induction period followed by a maintenance period (until confirmed disease progression, intolerable toxicity, participant withdrawal, study termination or up to 2 years \[whichever occurs first\]), and a follow-up (FU) period for all participants (2 safety FU visits and survival FU visits). In Stage 1, eligible participants will be randomized (1:1:1) to the arms. In Stage 2, participants will then be randomized (1:1) to the arms. The randomization will be stratified based on the following factors: 1. Brain or liver metastases per investigator assessment (presence versus absence); 2. Smoking status (smoker versus never-smoker); and 3. Geography. Participants will be allowed to switch to cisplatin if carboplatin is not tolerated at the investigator's discretion.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Pumitamig
Atezolizumab
Etoposide
Carboplatin (or cisplatin if carboplatin is not tolerated)
Conditions
Locations
ACRC Arizona Clinical Research Center
Tucson, Arizona 85715
United States
Clermont Oncology Center
Clermont, Florida 34711
United States
Cancer Care Centers of Brevard, Inc
Palm Bay, Florida 32901
United States
Northside Hospital Atlanta
Atlanta, Georgia 30342
United States
Illinois Cancer Specialists
Niles, Illinois 60714
United States
Fort Wayne Medical Oncology and Hematology, Inc
Fort Wayne, Indiana 46804
United States
McFarland Clinic
Ames, Iowa 50010
United States
Helen G. Nassif Community Cancer Center
Cedar Rapids, Iowa 52403
United States
Baptist Health Hardin Cancer Center
Elizabethtown, Kentucky 42701
United States
LSU Health Baton Rouge - North Clinic
Baton Rouge, Louisiana 70805
United States
Our Lady of the Lake Hospital, Inc.
Baton Rouge, Louisiana 70808
United States
Frederick Health Hospital- James M Stockman Cancer Institute
Frederick, Maryland 21704
United States
Beth Israel Lahey Health - Lahey Hospital & Medical Center (LHMC), Lahey Clinic Medical Center
Burlington, Massachusetts 01805
United States
Baptist Cancer Center
Southaven, Mississippi 38671
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Nebraska Hematology-Oncology (NHO)
Lincoln, Nebraska 68506
United States
Cornell University - NewYork-Presbyterian/Weill Cornell Medical Center
New York, New York 10065
United States
White Plains Hospital
White Plains, New York 10601
United States
Cleveland Clinic - Akron General Hematology & Oncology
Akron, Ohio 44302
United States
Cleveland Clinic Mercy Hospital Cancer Center
Canton, Ohio 44708
United States
The Christ Hospital Cancer Center
Cincinnati, Ohio 45219
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
The Cleveland Clinic Cancer Center at Fairview Hospital, Moll Pavilion
Cleveland, Ohio 44111
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195-0001
United States
Kettering Medical Center
Kettering, Ohio 45429
United States
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio 44124
United States
St. Luke's Physician Group - St. Luke's Cancer Care Associates
Fountain Hill, Pennsylvania 18015-1153
United States
West Cancer Center & Research Institute
Germantown, Tennessee 38138
United States
University of Tennessee Medical Center
Knoxville, Tennessee 37920
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Millennium Research and Clinical Development, LLC
Houston, Texas 77090
United States
Texas Oncology Cancer Center
Sugar Land, Texas 77479
United States
Virginia Cancer Specialists
Fairfax, Virginia 22031
United States
Hematology Oncology Associates of Fredericksburg, Inc.
Fredericksburg, Virginia 22408
United States
Virginia Commonwealth University School of Medicine
Richmond, Virginia 23298
United States
Shenandoah Oncology
Winchester, Virginia 22601
United States
Calvary Mater Newcastle
Waratah, New South Wales 2298
Australia
Cancer Care Wollongong Pty Limited
Wollongong, New South Wales 2500
Australia
Cairns Hospital
Cairns, Queensland 4870
Australia
Icon Cancer Centre Kurralta Park
Kurralta Park, South Australia 5037
Australia
The Queen Elizabeth Hospital
Woodville, South Australia 5011
Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria 3199
Australia
Olivia Newton-John Cancer Wellness & Research centre
Heidelberg, Victoria 3084
Australia
Western Health Sunshine Hospital
St Albans, Victoria 3021
Australia
Cairns Hospital
Cairns, 4870
Australia
Sir Charles Gairdner Hospital (SCGH)
Nedlands, 6009
Australia
Royal North Shore Hospital
Saint Leonards, 2065
Australia
Liverpool Hospital
Sydney, 2170
Australia
Jilin Cancer Hospital
Changchun, Jilin 130012
China
Affiliated Hospital of Hebei University
Baoding, 071105
China
Beijing Friendship Hospital, Capital Medical University
Beijing, 100050
China
Peking Union Medical College Hospital
Beijing, 100730
China
Beijing Chest Hospital,Capital Medical University
Beijing, 101149
China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, 233004
China
Fujian Provincial Cancer Hospital
Fuzhou, 350014
China
Guangdong General Hospital
Guangzhou, 510080
China
Zhejiang Medical University, Zhejiang Cancer Hospital
Hangzhou, 310022
China
Harbin Medical University Cancer Hospital
Ha’erbin, 150040
China
Cancer Hospital Chinese Academy of Medical Sciences
Hebei, 065001
China
Anhui Provincial Hospital
Hefei, 230001
China
Jiamusi Cancer Hospital
Jiamusi, 154007
China
Shandong University - Jinan Central Hospital
Jinan, 250013
China
Shandong Cancer Hospital and Institute
Jinan, 250117
China
Yunnan Provincial Cancer Hospital
Kunming, 650000
China
Linyi Cancer Hospital
Linyi, 276034
China
The First Affiliated Hospital of Nanchang University
Nanchang, 330006
China
Jiangsu Peoples Hospital
Nanjing, 210029
China
Guangxi Tumour Hospital
Nanning, 530000
China
Shanghai Chest Hospital
Shanghai, 200030
China
Fudan University - Shanghai Cancer Center (FUSCC)
Shanghai, 200032
China
Cancer Hospital of Shantou University Medical College
Shantou, 515041
China
The First Affiliated Hospital of Soochow University
Suzhou, 215006
China
Shanxi Provincial Tumor Hospital (Shanxi Oncology Hospital)
Taiyuan, 030013
China
Chongqing University Three Gorges Hospital
Wanzhou, 404000
China
The First Affiliated Hospital Of Wenzhou Medical University
Wenzhou, 325000
China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST)
Wuhan, 430022
China
Zhongnan Hospital of Wuhan University
Wuhan, 430071
China
Xiangyang Central Hospital
Xiangyang, 441000
China
The First Affiliated Hospital of Henan Medical University
Xinxiang, 453100
China
Northern Jiangsu Peoples Hospital (NJPH)
Yangzhou, 225001
China
Taizhou Hospital of Zhejiang Province
Zhejiang, 317000
China
Henan Cancer Hospital (Affiliated Cancer Hospital of Zhengzhou University)
Zhengzhou, 450008
China
Centre Hospitalier Universitaire d'Angers (CHU Angers)
Angers, 49933
France
Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, 33076
France
CHU de Caen
Caen, 14033
France
Institut Curie - Centre de Recherche
Paris, 75005
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 Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hopital Sainte Musse
Toulon, 83056
France
Evangelische Lungenklinik Berlin
Berlin, 13125
Germany
Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
Berlin, 13353
Germany
Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling
Bonn, 53123
Germany
Klinikum Chemnitz Gmbh
Chemnitz, 09116
Germany
Klinikum Esslingen GmbH
Esslingen am Neckar, 73730
Germany
Asklepios Fachkliniken Muenchen Gauting
Gauting, 82131
Germany
SRH Wald-Kliniken Gera GmbH
Gera, 07548
Germany
LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927
Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH
Halle, 06120
Germany
Klinikum Kempten-Oberallgau gGmbH
Kempten, 87439
Germany
Universitaetsklinikum Schleswig-Holstein (UKSH) - Campus Luebeck
Lübeck, 23538
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
Klinikum Nuernberg Nord
Nuremberg, 90419
Germany
Helios Klinikum Wuppertal-Universitaet Witten-Herdecke
Wuppertal, 42283
Germany
Azienda Ospedaliera San Giuseppe Moscati
Avellino, 83100
Italy
Centro di Riferimento Oncologico
Aviano, 33081
Italy
Azienda Socio Sanitaria Territoriale di Cremona
Cremona, 26100
Italy
Ospedale San Luca
Lucca, 55100
Italy
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" (IRST)
Meldola, 47014
Italy
Universita Degli Studi Di Milano-Bicocca - Azienda Ospedaliera San Gerardo Di Monza
Monza, 20900
Italy
UOC Oncoematologia AOU Luigi Vanvitelli
Naples, 80131
Italy
Casa Di Cura Polispecialistica Dott Pederzoli
Peschiera del Garda, 37019
Italy
Ageo Central General Hospital
Ageo, 362-8588
Japan
Tokyo Metropolitan Komagome Hospital
Bunkyō City, 113-8677
Japan
National Cancer Center Hospital
Chūōku, 104-0045
Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
Japan
Saitama Medical University International Medical Center
Hidaka, 350-1298
Japan
National Hospital Organization Himeji Medical Center
Himeji, 670-8520
Japan
National Hospital Organization Iwakuni Clinical Center
Iwakuni, 740-8510
Japan
Kobe City Medical Center General Hospital
Kobe, 650-0047
Japan
Kurume University Hospital
Kurume, 830-0011
Japan
Matsusaka Municipal Hospital
Matsusaka, 515-8544
Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, 791-0280
Japan
Sendai Kousei Hospital
Miyagi, 981-0914
Japan
National Hospital Organization Nagoya Medical Center
Nagoya, 460-0001
Japan
Niigata Cancer Center Hospital
Niigata, 951-8566
Japan
Okayama University Hospital
Okayama, 700-8558
Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Osaka, 541-8567
Japan
NHO Kinki Chuo Chest Medical Center
Sakai, 591-8555
Japan
Shibukawa Medical Center
Shibukawa, 377-0280
Japan
National Hospital Organization Yamaguchi-Ube Medical Center
Ube, 755-0241
Japan
Yokohama Municipal Citizen's Hospital
Yokohama, 221-0855
Japan
Kanagawa Cancer Center
Yokohama, 241-8515
Japan
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5223 GZ
Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
Poland
Pratia Onkologia Katowice
Katowice, 40-519
Poland
KOMED Roman Karaszewski I Wspolnicy Spolka Jawna
Konin, 62-500
Poland
Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie
Koszalin, 75-581
Poland
FutureMeds Krakow
Krakow, 31-501
Poland
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
Lublin, 20-090
Poland
Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie
Olsztyn, 10-357
Poland
Wielkopolskie Centrum Pulmonologii i Tarakochirurgii
Poznan, 60-569
Poland
Pratia S.A. , Pratia Poznan
Poznan, 60192
Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
Przemyśl, 37-700
Poland
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Warsaw, 04-349
Poland
Pratia Wroclaw Onkologia
Wroclaw, 50-019
Poland
SC Oncopremium Team SRL
Baia Mare, 430291
Romania
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti (IOB)
Bucharest, 022328
Romania
Coltea Clinical Hospital
Bucharest, 030171
Romania
Cardiomed
Cluj-Napoca, 400015
Romania
Centrul de Oncologie Sf. Nectarie S.R.L (Sf Nectarie Oncology Center)
Craiova, 200542
Romania
Centrul de Oncologie Euroclinic srl
Iași, 700106
Romania
City Hospital Onesti
Onești, 601048
Romania
Oncocenter Oncologie Clinica S.R.L
Timișoara, 300166
Romania
Oncomed
Timișoara, 300239
Romania
Korea University Guro Hospital
Seoul, Guro-gu 8308
South Korea
National Cancer Center
Goyang-si, Gyeonggi-do 10408
South Korea
The Catholic University Of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do 16247
South Korea
Ajou University Hospital
Suwon, Gyeonggi-do 16499
South Korea
Gyeongsang National University Hospital (GNUH)
Jinju, Gyeongsangnam-do 52727
South Korea
Gachon University Gil Medical Center
Incheon, Namdong-gu 21565
South Korea
Chungbuk National University Hospital
Cheongju-si, 28644
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 3722
South Korea
Asan Medical Center (AMC)
Seoul, 5505
South Korea
Samsung Medical Center
Seoul, 6351
South Korea
Hospital Universitario de Badajoz
Badajoz, 06006
Spain
Parc de Salut Mar - Hospital del Mar
Barcelona, 08003
Spain
UOMI Cancer Center-Clinica Tres Torres
Barcelona, 08017
Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Spain
Consorcio Hospitalario Provincial de Castellon
Castellon, 12002
Spain
Hospital Universitario De Leon
León, 24071
Spain
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid, 28007
Spain
Clinica MD Anderson International
Madrid, 28033
Spain
Hospital Regional Universitario de Malaga
Málaga, 29010
Spain
Universidad de Sevilla - Hospital Universitario Virgen Macarena
Seville, 41009
Spain
Hospital Universitario Nuestra Senora De Valme
Seville, 41014
Spain
Hospital Universitario de Torrejón
Torrejón de Ardoz, 28850
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 Clinico Universitario Lozano Blesa de Zaragoza
Zaragoza, 50009
Spain
Acibadem Adana Hospital
Adana, 1130
Turkey (Türkiye)
Seyhan Medical Park Hospital
Adana, 1140
Turkey (Türkiye)
Baskent University Adana Turgut Noyan Application and Research Center
Adana, 1250
Turkey (Türkiye)
Ankara Etlik City Hospital
Ankara, 06170
Turkey (Türkiye)
Gulhane Training and Research Hospital
Ankara, 6010
Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, 6200
Turkey (Türkiye)
Hacettepe University Medical Faculty Hospital
Ankara, 6230
Turkey (Türkiye)
Memorial Ankara Hospital
Ankara, 6520
Turkey (Türkiye)
Gazi University, Medical Faculty Hospital
Ankara, 6560
Turkey (Türkiye)
Liv Hospital Ankara
Ankara, 6680
Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, 6800
Turkey (Türkiye)
Akdeniz University Hospital
Antalya,
Turkey (Türkiye)
Trakya University Faculty of Medicine
Edirne, 22030
Turkey (Türkiye)
Koc Universitesi Hastanesi (Koc University Hospital)
Istanbul, 34010
Turkey (Türkiye)
Medical Park Florya Hospital
Istanbul, 34295
Turkey (Türkiye)
Yeditepe University Kosuyolu Hospital
Istanbul, 34718
Turkey (Türkiye)
Marmara University Pendik Training and Research Hospital
Istanbul, 34899
Turkey (Türkiye)
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, 41380
Turkey (Türkiye)
Medical Point Izmir Hospital
Izmir, 35575
Turkey (Türkiye)
Kocaeli University Medical Faculty Hospital
Kocaeli, 41380
Turkey (Türkiye)
Ankara University Medical Faculty Hospital
Mamak, 06220
Turkey (Türkiye)
Sakarya University Training and Research Hospital
Sakarya, 54290
Turkey (Türkiye)
The Christie NHS Foundation Trust
Manchester, Lancashire M20 4BX
United Kingdom
Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust
Chelsea, London SW3 6JJ
United Kingdom
Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust
Sutton, London SM2 5PT
United Kingdom
Huddersfield Royal Infirmary - Calderdale and Huddersfield NHS Foundation Trust
Huddersfield, North Yorkshire HD3 3EA
United Kingdom
Northern Centre for Cancer Care - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Northumberland NE7 7DN
United Kingdom
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
Nottingham, Nottinghamshire NG5 1PB
United Kingdom
Churchill Hospital - Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire OX3 7LE
United Kingdom
Ninewells Hospital and Medical School - Tayside Health Board
Dundee, Scotland DD1 9SY
United Kingdom
Torbay and South Devon NHS Foundation Trust
Torquay, South Devon TQ2 7AA
United Kingdom
Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire ST4 6QG
United Kingdom
Velindre NHS Trust, Velindre Cancer Centre
Cardiff, Wales CF14 2TL
United Kingdom
New Cross Hospital
Wolverhampton, West Midlands WV10 0QP
United Kingdom
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
United Kingdom
Hull University Teaching Hospitals NHS Trust
Cottingham, HU16 5JQ
United Kingdom
Royal Devon and Exeter Hospital, Royal Devon University Healthcare NHS Foundation Trust
Exeter, EX2 5DW
United Kingdom
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
United Kingdom
Guy's Hospital - Guy's & St Thomas' NHS Foundation Trust
London, SE1 9RT
United Kingdom
Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
Preston, PR2 9HT
United Kingdom