Extensive-stage Small-cell Lung CancerPhase 3NCT06712355
Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer
A Phase 3 study testing Pumitamig, Atezolizumab and Etoposide in people with Extensive-stage Small-cell Lung Cancer, run by BioNTech SE at 225 sites in 14 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-stage Small-cell Lung Cancer
- What is being tested?
- Pumitamig, Atezolizumab and Etoposide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 621 participants
- Where
- 225 sitesin 14 countries
- Study dates
- 3 Feb 2025to Jul 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have histologically or cytologically confirmed ES-SCLC (using the AJCC [American Joint Committee on Cancer] tumor node metastasis staging system combined with Veterans Administration Lung Study Group [VALG]'s two stage classification scheme). For AJCC tumor node metastasis staging system: AJCC 8th edition stage IV (T any, N any, M1a/b/c), or T3~4 for multiple lung nodules or tumor/nodule volume that cannot be encompassed in a tolerable radiotherapy plan.
- Have not had prior systemic therapy for ES-SCLC. However, participants with prior chemoradiotherapy for limited-stage-SCLC must have been treated with curative intent and had a treatment-free interval of at least 6 months after the last chemotherapy, radiotherapy, or chemoradiotherapy before diagnosis of ES-SCLC to be eligible.
- 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 (ECOG) performance status of 0 or 1.
- Adequate hematologic and organ function as defined in the protocol.
Who cannot join
- Have histologically or cytologically confirmed SCLC with combined histologies.
- Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:
- Within 2 weeks: small molecule agents with half-life of <7 days; radiation outside the thoracic cavity including whole brain radiation. Of note, other local radiation for brain lesions (not whole brain) is allowed; local radiation for bone lesions is allowed. Palliative bone radiation or brain stereotactic radiosurgery would not require a washout period, but participants should recover from radiotherapy-related toxicity.
- Within 4 weeks: radiation involving the thoracic cavity; small molecule targeted agents with half-life of ≥7 days; monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies.
- Have received prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or programmed death (ligand)-1 (PD[L]-1)/VEGF bispecific antibody.
- Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed.
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- Have the following central nervous system metastases:
- Participants with untreated brain metastases that are symptomatic or large (e.g., greater than 2 cm).
- Participants with treated central nervous system (CNS) metastases who are not neurologically stable or on steroids (at a dosage greater than 10 mg/Day of prednisone or an equivalent dose of other corticosteroid) within 7 days before initiating study treatment of this study.
- Participants with known leptomeningeal metastases.
- Have uncontrolled hypertension or poorly controlled diabetes prior to study treatment.
- Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess for which an interval of 6 months must pass before study entry. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation.
- Have a significant risk of hemorrhage (per investigator clinical judgment) as defined in the protocol.
- Have superior vena cava syndrome or symptoms of spinal cord compression that requires urgent medical intervention.
- NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
225 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
225 sites in 14 countries
United States36 sites, 34 recruiting
- Recruiting
Cleveland Clinic - Akron General Hematology & Oncology
Akron, Ohio, 44302
- Recruiting
McFarland Clinic
Ames, Iowa, 50010
- Recruiting
Northside Hospital Atlanta
Atlanta, Georgia, 30342
- Recruiting
LSU Health Baton Rouge - North Clinic
Baton Rouge, Louisiana, 70805
- Recruiting
Our Lady of the Lake Hospital, Inc.
Baton Rouge, Louisiana, 70808
- Recruiting
Beth Israel Lahey Health - Lahey Hospital & Medical Center (LHMC), Lahey Clinic Medical Center
Burlington, Massachusetts, 01805
- Recruiting
Cleveland Clinic Mercy Hospital Cancer Center
Canton, Ohio, 44708
- Recruiting
Helen G. Nassif Community Cancer Center
Cedar Rapids, Iowa, 52403
- Recruiting
The Christ Hospital Cancer Center
Cincinnati, Ohio, 45219
- Terminated
Clermont Oncology Center
Clermont, Florida, 34711
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
- Recruiting
The Cleveland Clinic Cancer Center at Fairview Hospital, Moll Pavilion
Cleveland, Ohio, 44111
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195-0001
- Recruiting
Baptist Health Hardin Cancer Center
Elizabethtown, Kentucky, 42701
- Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031
- Recruiting
Fort Wayne Medical Oncology and Hematology, Inc
Fort Wayne, Indiana, 46804
- Recruiting
St. Luke's Physician Group - St. Luke's Cancer Care Associates
Fountain Hill, Pennsylvania, 18015-1153
- Recruiting
Frederick Health Hospital- James M Stockman Cancer Institute
Frederick, Maryland, 21704
- Recruiting
Hematology Oncology Associates of Fredericksburg, Inc.
Fredericksburg, Virginia, 22408
- Recruiting
West Cancer Center & Research Institute
Germantown, Tennessee, 38138
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Terminated
Millennium Research and Clinical Development, LLC
Houston, Texas, 77090
- Recruiting
Kettering Medical Center
Kettering, Ohio, 45429
- Recruiting
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
- Recruiting
Nebraska Hematology-Oncology (NHO)
Lincoln, Nebraska, 68506
- Recruiting
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio, 44124
- Recruiting
Cornell University - NewYork-Presbyterian/Weill Cornell Medical Center
New York, New York, 10065
- Recruiting
Illinois Cancer Specialists
Niles, Illinois, 60714
- Recruiting
Cancer Care Centers of Brevard, Inc
Palm Bay, Florida, 32901
- Recruiting
Virginia Commonwealth University School of Medicine
Richmond, Virginia, 23298
- Recruiting
Baptist Cancer Center
Southaven, Mississippi, 38671
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
- Recruiting
Texas Oncology Cancer Center
Sugar Land, Texas, 77479
- Recruiting
ACRC Arizona Clinical Research Center
Tucson, Arizona, 85715
- Recruiting
White Plains Hospital
White Plains, New York, 10601
- Recruiting
Shenandoah Oncology
Winchester, Virginia, 22601
China34 sites
- Active, not recruiting
Affiliated Hospital of Hebei University
Baoding, 071105
- Active, not recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, 100050
- Withdrawn
Peking Union Medical College Hospital
Beijing, 100730
- Active, not recruiting
Beijing Chest Hospital,Capital Medical University
Beijing, 101149
- Active, not recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu, 233004
- Active, not recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130012
- Active, not recruiting
Fujian Provincial Cancer Hospital
Fuzhou, 350014
- Active, not recruiting
Guangdong General Hospital
Guangzhou, 510080
- Withdrawn
Harbin Medical University Cancer Hospital
Ha’erbin, 150040
- Active, not recruiting
Zhejiang Medical University, Zhejiang Cancer Hospital
Hangzhou, 310022
- Active, not recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Hebei, 065001
- Active, not recruiting
Anhui Provincial Hospital
Hefei, 230001
- Active, not recruiting
Jiamusi Cancer Hospital
Jiamusi, 154007
- Active, not recruiting
Shandong University - Jinan Central Hospital
Jinan, 250013
- Active, not recruiting
Shandong Cancer Hospital and Institute
Jinan, 250117
- Active, not recruiting
Yunnan Provincial Cancer Hospital
Kunming, 650000
- Active, not recruiting
Linyi Cancer Hospital
Linyi, 276034
- Active, not recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, 330006
- Active, not recruiting
Jiangsu Peoples Hospital
Nanjing, 210029
- Active, not recruiting
Guangxi Tumour Hospital
Nanning, 530000
- Active, not recruiting
Shanghai Chest Hospital
Shanghai, 200030
- Active, not recruiting
Fudan University - Shanghai Cancer Center (FUSCC)
Shanghai, 200032
- Withdrawn
Cancer Hospital of Shantou University Medical College
Shantou, 515041
- Active, not recruiting
The First Affiliated Hospital of Soochow University
Suzhou, 215006
- Active, not recruiting
Shanxi Provincial Tumor Hospital (Shanxi Oncology Hospital)
Taiyuan, 030013
- Active, not recruiting
Chongqing University Three Gorges Hospital
Wanzhou, 404000
- Withdrawn
The First Affiliated Hospital Of Wenzhou Medical University
Wenzhou, 325000
- Active, not recruiting
Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST)
Wuhan, 430022
- Active, not recruiting
Zhongnan Hospital of Wuhan University
Wuhan, 430071
- Active, not recruiting
Xiangyang Central Hospital
Xiangyang, 441000
- Active, not recruiting
The First Affiliated Hospital of Henan Medical University
Xinxiang, 453100
- Withdrawn
Northern Jiangsu Peoples Hospital (NJPH)
Yangzhou, 225001
- Active, not recruiting
Taizhou Hospital of Zhejiang Province
Zhejiang, 317000
- Active, not recruiting
Henan Cancer Hospital (Affiliated Cancer Hospital of Zhengzhou University)
Zhengzhou, 450008
Japan22 sites, 22 recruiting
- Recruiting
Ageo Central General Hospital
Ageo, 362-8588
- Recruiting
Tokyo Metropolitan Komagome Hospital
Bunkyō City, 113-8677
- Recruiting
National Cancer Center Hospital
Chūōku, 104-0045
- Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
- Recruiting
Saitama Medical University International Medical Center
Hidaka, 350-1298
- Recruiting
National Hospital Organization Himeji Medical Center
Himeji, 670-8520
- Recruiting
National Hospital Organization Iwakuni Clinical Center
Iwakuni, 740-8510
- Recruiting
Kobe City Medical Center General Hospital
Kobe, 650-0047
- Recruiting
Kurume University Hospital
Kurume, 830-0011
- Recruiting
Matsusaka Municipal Hospital
Matsusaka, 515-8544
- Recruiting
National Hospital Organization Shikoku Cancer Center
Matsuyama, 791-0280
- Recruiting
Sendai Kousei Hospital
Miyagi, 981-0914
- Recruiting
National Hospital Organization Nagoya Medical Center
Nagoya, 460-0001
- Recruiting
Niigata Cancer Center Hospital
Niigata, 951-8566
- Recruiting
Okayama University Hospital
Okayama, 700-8558
- Recruiting
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Osaka, 541-8567
- Recruiting
Saitama Prefectural Cancer Center
Saitama, 362-0806
- Recruiting
NHO Kinki Chuo Chest Medical Center
Sakai, 591-8555
- Recruiting
Shibukawa Medical Center
Shibukawa, 377-0280
- Recruiting
National Hospital Organization Yamaguchi-Ube Medical Center
Ube, 755-0241
- Recruiting
Yokohama Municipal Citizen's Hospital
Yokohama, 221-0855
- Recruiting
Kanagawa Cancer Center
Yokohama, 241-8515
Turkey (Türkiye)22 sites, 21 recruiting
- Withdrawn
Acibadem Adana Hospital
Adana, 1130
- Recruiting
Seyhan Medical Park Hospital
Adana, 1140
- Recruiting
Baskent University Adana Turgut Noyan Application and Research Center
Adana, 1250
- Recruiting
Ankara Etlik City Hospital
Ankara, 06170
- Recruiting
Gulhane Training and Research Hospital
Ankara, 6010
- Recruiting
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, 6200
- Recruiting
Hacettepe University Medical Faculty Hospital
Ankara, 6230
- Recruiting
Memorial Ankara Hospital
Ankara, 6520
- Recruiting
Gazi University, Medical Faculty Hospital
Ankara, 6560
- Recruiting
Liv Hospital Ankara
Ankara, 6680
- Recruiting
Ankara Bilkent City Hospital
Ankara, 6800
- Recruiting
Akdeniz University Hospital
Antalya
- Recruiting
Trakya University Faculty of Medicine
Edirne, 22030
- Recruiting
Koc Universitesi Hastanesi (Koc University Hospital)
Istanbul, 34010
- Recruiting
Medical Park Florya Hospital
Istanbul, 34295
- Recruiting
Yeditepe University Kosuyolu Hospital
Istanbul, 34718
- Recruiting
Marmara University Pendik Training and Research Hospital
Istanbul, 34899
- Recruiting
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, 41380
- Recruiting
Medical Point Izmir Hospital
Izmir, 35575
- Recruiting
Kocaeli University Medical Faculty Hospital
Kocaeli, 41380
- Recruiting
Ankara University Medical Faculty Hospital
Mamak, 06220
- Recruiting
Sakarya University Training and Research Hospital
Sakarya, 54290
United Kingdom18 sites, 18 recruiting
- Recruiting
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
- Recruiting
Velindre NHS Trust, Velindre Cancer Centre
Cardiff, Wales, CF14 2TL
- Recruiting
Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust
Chelsea, London, SW3 6JJ
- Recruiting
Hull University Teaching Hospitals NHS Trust
Cottingham, HU16 5JQ
- Recruiting
Ninewells Hospital and Medical School - Tayside Health Board
Dundee, Scotland, DD1 9SY
- Recruiting
Royal Devon and Exeter Hospital, Royal Devon University Healthcare NHS Foundation Trust
Exeter, EX2 5DW
- Recruiting
Huddersfield Royal Infirmary - Calderdale and Huddersfield NHS Foundation Trust
Huddersfield, North Yorkshire, HD3 3EA
- Recruiting
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
- Recruiting
Guy's Hospital - Guy's & St Thomas' NHS Foundation Trust
London, SE1 9RT
- Recruiting
The Christie NHS Foundation Trust
Manchester, Lancashire, M20 4BX
- Recruiting
Northern Centre for Cancer Care - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Northumberland, NE7 7DN
- Recruiting
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
Nottingham, Nottinghamshire, NG5 1PB
- Recruiting
Churchill Hospital - Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 7LE
- Recruiting
Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
Preston, PR2 9HT
- Recruiting
Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, ST4 6QG
- Recruiting
Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust
Sutton, London, SM2 5PT
- Recruiting
Torbay and South Devon NHS Foundation Trust
Torquay, South Devon, TQ2 7AA
- Recruiting
New Cross Hospital
Wolverhampton, West Midlands, WV10 0QP
Germany16 sites, 16 recruiting
- Recruiting
Evangelische Lungenklinik Berlin
Berlin, 13125
- Recruiting
Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
Berlin, 13353
- Recruiting
Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling
Bonn, 53123
- Recruiting
Klinikum Chemnitz Gmbh
Chemnitz, 09116
- Recruiting
Klinikum Esslingen GmbH
Esslingen am Neckar, 73730
- Recruiting
Asklepios Fachkliniken Muenchen Gauting
Gauting, 82131
- Recruiting
SRH Wald-Kliniken Gera GmbH
Gera, 07548
- Recruiting
LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927
- Recruiting
Krankenhaus Martha-Maria Halle-Doelau gGmbH
Halle, 06120
- Recruiting
Klinikum Kempten-Oberallgau gGmbH
Kempten, 87439
- Recruiting
Universitaetsklinikum Schleswig-Holstein (UKSH) - Campus Luebeck
Lübeck, 23538
- Recruiting
University Medical Center of Johannes Gutenberg-University Mainz
Mainz, 55131
- Recruiting
Staedtisches Klinikum Muenchen Bogenhausen
München, 81925
- Recruiting
MVZ for oncology and hematology Rhein-Kreis Neuss GmbH
Neuss, 41462
- Recruiting
Klinikum Nuernberg Nord
Nuremberg, 90419
- Recruiting
Helios Klinikum Wuppertal-Universitaet Witten-Herdecke
Wuppertal, 42283
Poland15 sites, 15 recruiting
- Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
- Recruiting
Katowickie Centrum Onkologii
Katowice, 40-074
- Recruiting
Pratia Onkologia Katowice
Katowice, 40-519
- Recruiting
KOMED Roman Karaszewski I Wspolnicy Spolka Jawna
Konin, 62-500
- Recruiting
Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie
Koszalin, 75-581
- Recruiting
FutureMeds Krakow
Krakow, 31-501
- Recruiting
N.Copernicus Memorial Hospital
Lodz, 93-513
- Recruiting
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
Lublin, 20-090
- Recruiting
Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie
Olsztyn, 10-357
- Recruiting
Wielkopolskie Centrum Pulmonologii i Tarakochirurgii
Poznan, 60-569
- Recruiting
Pratia S.A. , Pratia Poznan
Poznan, 60192
- Recruiting
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
Przemyśl, 37-700
- Recruiting
Maria Sklodowska Curie National Research Institute of Oncology
Warsaw, 02-781
- Recruiting
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Warsaw, 04-349
- Recruiting
Pratia Wroclaw Onkologia
Wroclaw, 50-019
Spain15 sites, 15 recruiting
- Recruiting
Hospital Universitario de Badajoz
Badajoz, 06006
- Recruiting
Parc de Salut Mar - Hospital del Mar
Barcelona, 08003
- Recruiting
UOMI Cancer Center-Clinica Tres Torres
Barcelona, 08017
- Recruiting
Hospital Universitario Vall d'Hebron
Barcelona, 08035
- Recruiting
Consorcio Hospitalario Provincial de Castellon
Castellon, 12002
- Recruiting
Hospital Universitario De Leon
León, 24071
- Recruiting
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid, 28007
- Recruiting
Clinica MD Anderson International
Madrid, 28033
- Recruiting
Hospital Regional Universitario de Malaga
Málaga, 29010
- Recruiting
Universidad de Sevilla - Hospital Universitario Virgen Macarena
Seville, 41009
- Recruiting
Hospital Universitario Nuestra Senora De Valme
Seville, 41014
- Recruiting
Hospital Universitario de Torrejón
Torrejón de Ardoz, 28850
- Recruiting
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, 46026
- Recruiting
Hospital Alvaro Cunqueiro
Vigo, 36312
- Recruiting
Hospital Clinico Universitario Lozano Blesa de Zaragoza
Zaragoza, 50009
Australia12 sites, 12 recruiting
- Recruiting
Cairns Hospital
Cairns, Queensland, 4870
- Recruiting
Cairns Hospital
Cairns, 4870
- Recruiting
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, 3199
- Recruiting
Olivia Newton-John Cancer Wellness & Research centre
Heidelberg, Victoria, 3084
- Recruiting
Icon Cancer Centre Kurralta Park
Kurralta Park, South Australia, 5037
- Recruiting
Sir Charles Gairdner Hospital (SCGH)
Nedlands, 6009
- Recruiting
Royal North Shore Hospital
Saint Leonards, 2065
- Recruiting
Western Health Sunshine Hospital
St Albans, Victoria, 3021
- Recruiting
Liverpool Hospital
Sydney, 2170
- Recruiting
Calvary Mater Newcastle
Waratah, New South Wales, 2298
- Recruiting
Cancer Care Wollongong Pty Limited
Wollongong, New South Wales, 2500
- Recruiting
The Queen Elizabeth Hospital
Woodville, South Australia, 5011
South Korea10 sites, 10 recruiting
- Recruiting
Chungbuk National University Hospital
Cheongju-si, 28644
- Recruiting
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
- Recruiting
Gachon University Gil Medical Center
Incheon, Namdong-gu, 21565
- Recruiting
Gyeongsang National University Hospital (GNUH)
Jinju, Gyeongsangnam-do, 52727
- Recruiting
Korea University Guro Hospital
Seoul, Guro-gu, 8308
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 3722
- Recruiting
Asan Medical Center (AMC)
Seoul, 5505
- Recruiting
Samsung Medical Center
Seoul, 6351
- Recruiting
The Catholic University Of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
- Recruiting
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
Romania9 sites, 9 recruiting
- Recruiting
SC Oncopremium Team SRL
Baia Mare, 430291
- Recruiting
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti (IOB)
Bucharest, 022328
- Recruiting
Coltea Clinical Hospital
Bucharest, 030171
- Recruiting
Cardiomed
Cluj-Napoca, 400015
- Recruiting
Centrul de Oncologie Sf. Nectarie S.R.L (Sf Nectarie Oncology Center)
Craiova, 200542
- Recruiting
Centrul de Oncologie Euroclinic srl
Iași, 700106
- Recruiting
City Hospital Onesti
Onești, 601048
- Recruiting
Oncocenter Oncologie Clinica S.R.L
Timișoara, 300166
- Recruiting
Oncomed
Timișoara, 300239
Italy8 sites, 8 recruiting
- Recruiting
Azienda Ospedaliera San Giuseppe Moscati
Avellino, 83100
- Recruiting
Centro di Riferimento Oncologico
Aviano, 33081
- Recruiting
Azienda Socio Sanitaria Territoriale di Cremona
Cremona, 26100
- Recruiting
Ospedale San Luca
Lucca, 55100
- Recruiting
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" (IRST)
Meldola, 47014
- Recruiting
Universita Degli Studi Di Milano-Bicocca - Azienda Ospedaliera San Gerardo Di Monza
Monza, 20900
- Recruiting
UOC Oncoematologia AOU Luigi Vanvitelli
Naples, 80131
- Recruiting
Casa Di Cura Polispecialistica Dott Pederzoli
Peschiera del Garda, 37019
France7 sites, 7 recruiting
- Recruiting
Centre Hospitalier Universitaire d'Angers (CHU Angers)
Angers, 49933
- Recruiting
Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, 33076
- Recruiting
CHU de Caen
Caen, 14033
- Recruiting
Institut Curie - Centre de Recherche
Paris, 75005
- Recruiting
CHU de Rennes, Hopital de Pontchaillou
Rennes, 35033
- Recruiting
Institut de Cancerologie de l'Ouest (ICO)- CRLCC Rene Gauducheau
Saint-Herblain, 44805
- Recruiting
Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hopital Sainte Musse
Toulon, 83056
Netherlands1 site, 1 recruiting
- Recruiting
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5223 GZ
About this study
Official title: 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
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).
Read the 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:
- Brain or liver metastases per investigator assessment (presence versus absence);
- Smoking status (smoker versus never-smoker); and
- Geography.
Participants will be allowed to switch to cisplatin if carboplatin is not tolerated at the investigator's discretion.
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Being tested
- Pumitamig, Atezolizumab, Etoposide, Carboplatin (or cisplatin if carboplatin is not tolerated)
- Keywords
- First-line ES-SCLC, SCLC, Immunotherapy in combination with chemotherapy, Untreated, Bispecific antibody, Programmed death-ligand 1 (PD-L1), Vascular endothelial growth factor (VEGF) A, Immunotherapy, Combination with other investigational agents, Pumitamig, BNT327, Check point inhibitor, Lung cancer, Etoposide, Carboplatin, Cisplatin
- Medical subject headings
- Small Cell Lung Carcinoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PumitamigDrug
Also called BNT327, BMS-986545, PM8002
Intravenous infusion
AtezolizumabDrug
Intravenous infusion
EtoposideDrug
Intravenous infusion and capsules
Carboplatin (or cisplatin if carboplatin is not tolerated)Drug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 Control Arm - Atezolizumab + Etoposide + Carboplatin | Active comparator | Not described Receives: Drug: Atezolizumab; Drug: Etoposide; Drug: Carboplatin (or cisplatin if carboplatin is not tolerated) |
| Stage 1 Treatment Arm 1 - Pumitamig Dose 1 + Etoposide + Carboplatin | Experimental | Not described Receives: Drug: Pumitamig; Drug: Etoposide; Drug: Carboplatin (or cisplatin if carboplatin is not tolerated) |
| Stage 1 Treatment Arm 2 - Pumitamig Dose 2 + Etoposide + Carboplatin | Experimental | Not described Receives: Drug: Pumitamig; Drug: Etoposide; Drug: Carboplatin (or cisplatin if carboplatin is not tolerated) |
| Stage 2 Control Arm - Atezolizumab + Etoposide + Carboplatin | Active comparator | Not described Receives: Drug: Atezolizumab; Drug: Etoposide; Drug: Carboplatin (or cisplatin if carboplatin is not tolerated) |
| Stage 2 Treatment Arm - Pumitamig Dose 3 + Etoposide + Carboplatin | Experimental | Not described Receives: Drug: Pumitamig; Drug: Etoposide; Drug: Carboplatin (or cisplatin if carboplatin is not tolerated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS defined as the time from randomization to death from any cause.
Measured: Up to approximately 46 months
Secondary outcomes (13)
Progression-free survival (PFS)
PFS defined as the time from randomization to first objective tumor progression (progressive disease per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1]), or death from any cause, whichever occurs first.
Measured: Up to approximately 46 months
Objective response rate (ORR)
ORR defined as the proportion of participants in whom a complete response (CR) or partial response (PR) (based on investigator's assessment per RECIST v1.1) is observed as best overall response with confirmation.
Measured: Up to approximately 46 months
Duration of response (DOR)
DOR defined as the time from onset of objective response (confirmed CR or PR based on investigator's assessment per RECIST v1.1) to first occurrence of objective tumor progression (progressive disease per RECIST v1.1) or death from any cause, whichever occurs first.
Measured: Up to approximately 46 months
PFS rate based on investigator's assessment
Measured: At 6, 12, and 18 months
OS rate
Measured: At 6, 12, 18, and 24 months
Occurrence of treatment-emergent adverse events (TEAEs) including Grade ≥3, serious, and fatal TEAEs by relationship
TEAEs graded according to (US) National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0
Measured: From the first dose of study treatment to the 90-Day Follow-up Visit
Occurrence of dose delay, infusion interruption and discontinuation of study treatment due to TEAEs (including related TEAEs)
Measured: From first to last dose of study treatment, i.e., up to 2 years
Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Core 30 questionnaire (QLQ-C30) Global Health status/Quality-of-Life score (Items 29 and 30)
Global health status/QoL scale ranges in score from 0 to 100 with a high scale score representing a higher response level (e.g., high score for global health status/QoL is high QoL: high score for symptom scale/item is high symptomatology or problems).
Measured: Up to approximately 46 months
Change from baseline in EORTC QLQ-C30 physical functioning
Physical functioning scale ranges in score from 0 to 100 with a high scale score representing a higher response level (e.g., high score for functional scale is high/healthy level of functioning).
Measured: Up to approximately 46 months
Change from baseline in coughing scale of the EORTC Quality-of-Life-Lung cancer 29 questionnaire (QLQ-LC29)
Multi-item coughing scale ranges in score from 0 to 100 with a high score representing a high level of symptomatology or problems.
Measured: Up to approximately 46 months
Change from baseline in shortness of breath scale of the EORTC QLQ-LC29
Multi-item shortness of breath scale ranges in score from 0 to 100 with a high score representing a high level of symptomatology or problems.
Measured: Up to approximately 46 months
Change from baseline in coughed up blood item of the EORTC QLQ-LC29
Single item coughing up blood ranges in score from 0 to 100 with a high score representing a high level of symptomatology or problems.
Measured: Up to approximately 46 months
Change from baseline in Functional Assessment of Cancer Therapy-General overall bother item (FACT-GP5).
The FACT-G - Item GP5 (Version 4) is a single-item summary measure of the overall impact of treatment toxicity, based upon its association with the number and degree of AEs in clinical studies, rated on a 5-point Likert scale ("not at all" to "very much") with a recall period of past 7 days. A high score represents high level of problems.
Measured: Up to approximately 46 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start3 Feb 2025
- Primary completionApr 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-stage Small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by BioNTech SEThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 621 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioNTech SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- BioNTech Responsible Person, Study director, BioNTech SE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712355
- Sponsor's protocol ID
- BNT327-03
- Other IDs
- 2024-515765-34-00
- Status last verified
- Oct 2026
- First submitted
- 11 Nov 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No