Actively Recruiting
Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer
Led by BioNTech SE · Updated on 2026-02-13
621
Participants Needed
138
Research Sites
212 weeks
Total Duration
On this page
Sponsors
B
BioNTech SE
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed extensive-stage small-cell lung cancer (ES-SCLC) using AJCC 8th edition stage IV or specific tumor characteristics
- No prior systemic therapy for ES-SCLC; prior chemoradiotherapy for limited-stage SCLC allowed if treated with curative intent and treatment-free for at least 6 months
- At least one measurable lesion based on RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate hematologic and organ function as defined in the protocol
You will not qualify if you...
- Small-cell lung cancer with combined histologies
- Recent treatments prior to study: small molecule agents within 2 weeks; thoracic radiation within 4 weeks; certain antibody or cell-based therapies within 4 weeks
- Prior treatment with anti-VEGF monoclonal antibody or PD(L)-1/VEGF bispecific antibody
- Systemic corticosteroids above 10 mg/day prednisone equivalent within 7 days before starting study treatment
- Untreated symptomatic brain metastases larger than 2 cm, unstable treated CNS metastases, or known leptomeningeal metastases
- Uncontrolled hypertension or poorly controlled diabetes
- Serious or non-healing wounds, incompletely healed bone fractures, or recent history of fistula or gastrointestinal perforation requiring healing
- Significant risk of hemorrhage as judged by the investigator
- Superior vena cava syndrome or spinal cord compression requiring urgent intervention
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 138 locations
1
Clermont Oncology Center
Clermont, Florida, United States, 34711
Terminated
2
Cancer Care Centers of Brevard, Inc
Palm Bay, Florida, United States, 32901
Actively Recruiting
3
Illinois Cancer Specialists
Niles, Illinois, United States, 60714
Actively Recruiting
4
Fort Wayne Medical Oncology and Hematology, Inc
Fort Wayne, Indiana, United States, 46804
Actively Recruiting
5
McFarland Clinic
Ames, Iowa, United States, 50010
Actively Recruiting
6
Helen G. Nassif Community Cancer Center
Cedar Rapids, Iowa, United States, 52403
Actively Recruiting
7
Baptist Health Hardin Cancer Center
Elizabethtown, Kentucky, United States, 42701
Actively Recruiting
8
Frederick Health Hospital- James M Stockman Cancer Institute
Frederick, Maryland, United States, 21704
Actively Recruiting
9
Beth Israel Lahey Health - Lahey Hospital & Medical Center (LHMC), Lahey Clinic Medical Center
Burlington, Massachusetts, United States, 01805
Actively Recruiting
10
Baptist Cancer Center
Southaven, Mississippi, United States, 38671
Actively Recruiting
11
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
12
Nebraska Hematology-Oncology (NHO)
Lincoln, Nebraska, United States, 68506
Actively Recruiting
13
White Plains Hospital
White Plains, New York, United States, 10601
Actively Recruiting
14
Cleveland Clinic - Akron General Hematology & Oncology
Akron, Ohio, United States, 44302
Actively Recruiting
15
Cleveland Clinic Mercy Hospital Cancer Center
Canton, Ohio, United States, 44708
Actively Recruiting
16
The Christ Hospital Cancer Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
17
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
18
The Cleveland Clinic Cancer Center at Fairview Hospital, Moll Pavilion
Cleveland, Ohio, United States, 44111
Actively Recruiting
19
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195-0001
Actively Recruiting
20
Kettering Medical Center
Kettering, Ohio, United States, 45429
Actively Recruiting
21
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
Actively Recruiting
22
St. Luke's Physician Group - St. Luke's Cancer Care Associates
Fountain Hill, Pennsylvania, United States, 18015-1153
Actively Recruiting
23
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Actively Recruiting
24
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
25
Millennium Research and Clinical Development, LLC
Houston, Texas, United States, 77090
Terminated
26
Texas Oncology Cancer Center
Sugar Land, Texas, United States, 77479
Actively Recruiting
27
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
28
Hematology Oncology Associates of Fredericksburg, Inc.
Fredericksburg, Virginia, United States, 22408
Actively Recruiting
29
Virginia Commonwealth University School of Medicine
Richmond, Virginia, United States, 23298
Actively Recruiting
30
Shenandoah Oncology
Winchester, Virginia, United States, 22601
Actively Recruiting
31
Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2298
Actively Recruiting
32
Cancer Care Wollongong Pty Limited
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
33
Cairns Hospital
Cairns, Queensland, Australia, 4870
Actively Recruiting
34
Icon Cancer Centre Kurralta Park
Kurralta Park, South Australia, Australia, 5037
Actively Recruiting
35
The Queen Elizabeth Hospital
Woodville, South Australia, Australia, 5011
Actively Recruiting
36
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia, 3199
Actively Recruiting
37
Olivia Newton-John Cancer Wellness & Research centre
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
38
Western Health Sunshine Hospital
St Albans, Victoria, Australia, 3021
Actively Recruiting
39
Cairns Hospital
Cairns, Australia, 4870
Actively Recruiting
40
Royal North Shore Hospital
Saint Leonards, Australia, 2065
Actively Recruiting
41
Jilin Cancer Hospital
Changchun, Jilin, China, 130012
Actively Recruiting
42
Affiliated Hospital of Hebei University
Baoding, China, 071105
Actively Recruiting
43
Beijing Friendship Hospital, Capital Medical University
Beijing, China, 100050
Actively Recruiting
44
Peking Union Medical College Hospital
Beijing, China, 100730
Actively Recruiting
45
Beijing Chest Hospital,Capital Medical University
Beijing, China, 101149
Actively Recruiting
46
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China, 233004
Actively Recruiting
47
Zhejiang Medical University, Zhejiang Cancer Hospital
Hangzhou, China, 310022
Actively Recruiting
48
Jiamusi Cancer Hospital
Jiamusi, China, 154007
Actively Recruiting
49
Shandong University - Jinan Central Hospital
Jinan, China, 250013
Actively Recruiting
50
Shandong Cancer Hospital and Institute
Jinan, China, 250117
Actively Recruiting
51
Linyi Cancer Hospital
Linyi, China, 276034
Actively Recruiting
52
The First Affiliated Hospital of Nanchang University
Nanchang, China, 330006
Actively Recruiting
53
Jiangsu Peoples Hospital
Nanjing, China, 210029
Actively Recruiting
54
Guangxi Tumour Hospital
Nanning, China, 530000
Actively Recruiting
55
Shanghai Chest Hospital
Shanghai, China, 200030
Actively Recruiting
56
Fudan University - Shanghai Cancer Center (FUSCC)
Shanghai, China, 200032
Actively Recruiting
57
Cancer Hospital of Shantou University Medical College
Shantou, China, 515041
Actively Recruiting
58
The First Affiliated Hospital of Soochow University
Suzhou, China, 215006
Actively Recruiting
59
Shanxi Provincial Tumor Hospital (Shanxi Oncology Hospital)
Taiyuan, China, 030013
Actively Recruiting
60
Chongqing University Three Gorges Hospital
Wanzhou, China, 404000
Actively Recruiting
61
The First Affiliated Hospital Of Wenzhou Medical University
Wenzhou, China, 325000
Actively Recruiting
62
Zhongnan Hospital of Wuhan University
Wuhan, China, 430071
Actively Recruiting
63
Xiangyang Central Hospital
Xiangyang, China, 441000
Actively Recruiting
64
The First Affiliated Hospital of Henan Medical University
Xinxiang, China, 453100
Actively Recruiting
65
Northern Jiangsu Peoples Hospital (NJPH)
Yangzhou, China, 225001
Actively Recruiting
66
Taizhou Hospital of Zhejiang Province
Zhejiang, China, 317000
Actively Recruiting
67
Evangelische Lungenklinik Berlin
Berlin, Germany, 13125
Actively Recruiting
68
Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling
Bonn, Germany, 53123
Actively Recruiting
69
SRH Wald-Kliniken Gera GmbH
Gera, Germany, 07548
Actively Recruiting
70
LungenClinic Grosshansdorf GmbH
Großhansdorf, Germany, 22927
Actively Recruiting
71
MVZ for oncology and hematology Rhein-Kreis Neuss GmbH
Neuss, Germany, 41462
Actively Recruiting
72
Helios Klinikum Wuppertal-Universitaet Witten-Herdecke
Wuppertal, Germany, 42283
Actively Recruiting
73
Tokyo Metropolitan Komagome Hospital
Bunkyō City, Japan, 113-8677
Actively Recruiting
74
National Cancer Center Hospital
Chūōku, Japan, 104-0045
Actively Recruiting
75
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan, 811-1395
Actively Recruiting
76
National Hospital Organization Himeji Medical Center
Himeji, Japan, 670-8520
Actively Recruiting
77
National Hospital Organization Iwakuni Clinical Center
Iwakuni, Japan, 740-8510
Actively Recruiting
78
Kurume University Hospital
Kurume, Japan, 830-0011
Actively Recruiting
79
National Hospital Organization Shikoku Cancer Center
Matsuyama, Japan, 791-0280
Actively Recruiting
80
Sendai Kousei Hospital
Miyagi, Japan, 981-0914
Actively Recruiting
81
Niigata Cancer Center Hospital
Niigata, Japan, 951-8566
Actively Recruiting
82
Okayama University Hospital
Okayama, Japan, 700-8558
Actively Recruiting
83
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Osaka, Japan, 541-8567
Actively Recruiting
84
NHO Kinki Chuo Chest Medical Center
Sakai, Japan, 591-8555
Actively Recruiting
85
KOMED Roman Karaszewski I Wspolnicy Spolka Jawna
Konin, Poland, 62-500
Actively Recruiting
86
FutureMeds Krakow
Krakow, Poland, 31-501
Actively Recruiting
87
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
Przemyśl, Poland, 37-700
Actively Recruiting
88
Korea University Guro Hospital
Seoul, Guro-gu, South Korea, 8308
Actively Recruiting
89
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea, 10408
Actively Recruiting
90
The Catholic University Of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea, 16247
Actively Recruiting
91
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea, 16499
Actively Recruiting
92
Gyeongsang National University Hospital (GNUH)
Jinju, Gyeongsangnam-do, South Korea, 52727
Actively Recruiting
93
Gachon University Gil Medical Center
Incheon, Namdong-gu, South Korea, 21565
Actively Recruiting
94
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 3722
Actively Recruiting
95
Asan Medical Center (AMC)
Seoul, South Korea, 5505
Actively Recruiting
96
Samsung Medical Center
Seoul, South Korea, 6351
Actively Recruiting
97
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid, Spain, 28007
Actively Recruiting
98
Hospital Universitario Nuestra Senora De Valme
Seville, Spain, 41014
Actively Recruiting
99
Hospital Clinico Universitario Lozano Blesa de Zaragoza
Zaragoza, Spain, 50009
Actively Recruiting
100
Acibadem Adana Hospital
Adana, Turkey (Türkiye), 1130
Actively Recruiting
101
Seyhan Medical Park Hospital
Adana, Turkey (Türkiye), 1140
Actively Recruiting
102
Baskent University Adana Turgut Noyan Application and Research Center
Adana, Turkey (Türkiye), 1250
Actively Recruiting
103
Ankara Etlik City Hospital
Ankara, Turkey (Türkiye), 06170
Actively Recruiting
104
Gulhane Training and Research Hospital
Ankara, Turkey (Türkiye), 6010
Actively Recruiting
105
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, Turkey (Türkiye), 6200
Actively Recruiting
106
Hacettepe University Medical Faculty Hospital
Ankara, Turkey (Türkiye), 6230
Actively Recruiting
107
Memorial Ankara Hospital
Ankara, Turkey (Türkiye), 6520
Actively Recruiting
108
Gazi University, Medical Faculty Hospital
Ankara, Turkey (Türkiye), 6560
Actively Recruiting
109
Liv Hospital Ankara
Ankara, Turkey (Türkiye), 6680
Actively Recruiting
110
Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye), 6800
Actively Recruiting
111
Akdeniz University Hospital
Antalya, Turkey (Türkiye)
Actively Recruiting
112
Trakya University Faculty of Medicine
Edirne, Turkey (Türkiye), 22030
Actively Recruiting
113
Koc Universitesi Hastanesi (Koc University Hospital)
Istanbul, Turkey (Türkiye), 34010
Actively Recruiting
114
Medical Park Florya Hospital
Istanbul, Turkey (Türkiye), 34295
Actively Recruiting
115
Yeditepe University Kosuyolu Hospital
Istanbul, Turkey (Türkiye), 34718
Actively Recruiting
116
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, Turkey (Türkiye), 41380
Actively Recruiting
117
Medical Point Izmir Hospital
Izmir, Turkey (Türkiye), 35575
Actively Recruiting
118
Kocaeli University Medical Faculty Hospital
Kocaeli, Turkey (Türkiye), 41380
Actively Recruiting
119
Ankara University Medical Faculty Hospital
Mamak, Turkey (Türkiye), 06220
Actively Recruiting
120
Sakarya University Training and Research Hospital
Sakarya, Turkey (Türkiye), 54290
Actively Recruiting
121
The Christie NHS Foundation Trust
Manchester, Lancashire, United Kingdom, M20 4BX
Actively Recruiting
122
Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust
Chelsea, London, United Kingdom, SW3 6JJ
Actively Recruiting
123
Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust
Sutton, London, United Kingdom, SM2 5PT
Actively Recruiting
124
Huddersfield Royal Infirmary - Calderdale and Huddersfield NHS Foundation Trust
Huddersfield, North Yorkshire, United Kingdom, HD3 3EA
Actively Recruiting
125
Northern Centre for Cancer Care - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Northumberland, United Kingdom, NE7 7DN
Actively Recruiting
126
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Actively Recruiting
127
Churchill Hospital - Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom, OX3 7LE
Actively Recruiting
128
Ninewells Hospital and Medical School - Tayside Health Board
Dundee, Scotland, United Kingdom, DD1 9SY
Actively Recruiting
129
Torbay and South Devon NHS Foundation Trust
Torquay, South Devon, United Kingdom, TQ2 7AA
Actively Recruiting
130
Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
Actively Recruiting
131
Velindre NHS Trust, Velindre Cancer Centre
Cardiff, Wales, United Kingdom, CF14 2TL
Actively Recruiting
132
New Cross Hospital
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
Actively Recruiting
133
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
134
Hull University Teaching Hospitals NHS Trust
Cottingham, United Kingdom, HU16 5JQ
Actively Recruiting
135
Royal Devon and Exeter Hospital, Royal Devon University Healthcare NHS Foundation Trust
Exeter, United Kingdom, EX2 5DW
Actively Recruiting
136
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
137
Guy's Hospital - Guy's & St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT
Actively Recruiting
138
Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
Preston, United Kingdom, PR2 9HT
Actively Recruiting
Research Team
B
BioNTech clinical trials patient information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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