Actively Recruiting
A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer
Led by BioNTech SE · Updated on 2026-04-15
594
Participants Needed
58
Research Sites
317 weeks
Total Duration
On this page
Sponsors
B
BioNTech SE
Lead Sponsor
D
DualityBio Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study aims to investigate the combination of BNT324, a B7-H3 antibody-drug conjugate (ADC) with BNT327, a programmed death-ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF) bispecific antibody, in participants with advanced/metastatic or relapsed/progressive small cell lung cancer (SCLC) and non small cell lung cancer (NSCLC).
CONDITIONS
Official Title
A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older at the time of consent.
- Histologically or cytologically confirmed unresectable advanced or metastatic lung cancer.
- Participants with NSCLC are eligible regardless of PD-L1 expression.
- Participants with AGA-positive disease must have received targeted therapy before joining.
- Specific cohorts include treatment-na�ve and relapsed NSCLC and SCLC patients as defined.
- Must have measurable disease by RECIST version 1.1 criteria.
- Eastern Cooperative Oncology Group performance status must be 0 or 1.
- Life expectancy of at least 12 weeks.
You will not qualify if you...
- Prior treatment with B7-H3 targeted therapy.
- Prior treatment with antibody-drug conjugates containing topoisomerase inhibitors for first-line or treatment-na�ve advanced/metastatic patients.
- Candidates for locoregional treatments aiming for complete or near-complete tumor response.
- History of severe blood-related toxicities from previous treatments, such as Grade 4 febrile neutropenia or persistent Grade 3 to 4 neutropenia.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 58 locations
1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 13400
Actively Recruiting
2
Precision NextGen Oncology and Research Center
Beverly Hills, California, United States, 90212
Actively Recruiting
3
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
4
UCLA - David Geffen School of Medicine
Santa Monica, California, United States, 90404
Actively Recruiting
5
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
6
University of Iowa Hospitals & Clinics PARENT
Iowa City, Iowa, United States, 52242
Actively Recruiting
7
Mayo Clinic-Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
8
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, United States, 07601
Actively Recruiting
9
Memorial Sloan Kettering Cancer Center (MSKCC)
New York, New York, United States, 10021
Actively Recruiting
10
Icahn School of Medicine at Mount Sinai PRIME
New York, New York, United States, 10029
Actively Recruiting
11
Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Actively Recruiting
12
Texas Oncology - DFW
Dallas, Texas, United States, 75246
Actively Recruiting
13
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
14
Texas Oncology - Northeast
Tyler, Texas, United States, 75702
Actively Recruiting
15
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
16
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
17
Bendigo Hospital
Bendigo, Victoria, Australia, 3550
Actively Recruiting
18
Barwon Health
Geelong, Victoria, Australia, 3220
Actively Recruiting
19
Sunshine Hospital
Saint Albans, Victoria, Australia, 3021
Actively Recruiting
20
St John of God Subiaco Hospital
Subiaco, Western Australia, Australia, 6008
Actively Recruiting
21
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
22
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, 102200
Actively Recruiting
23
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
24
Guangxi Medical University Cancer Hospital
Nanning, Guangxi Zhuang, China, 530021
Actively Recruiting
25
The First Affiliated Hospital of Xinxiang Medical University
Weihui, Henan, China, 453100
Actively Recruiting
26
Henan Provincial Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
27
Jingzhou First People's Hospital
Jingzhou, Hubei, China, 434000
Actively Recruiting
28
Xiangyang Central Hospital
Xiangyang, Hubei, China, 441021
Actively Recruiting
29
Yichang Central People's Hospital
Yichang, Hubei, China, 443000
Actively Recruiting
30
Nanjing Chest Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
31
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
32
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330209
Actively Recruiting
33
Jilin Cancer Hospital
Changchun, Jilin, China, 130000
Actively Recruiting
34
Linyi Cancer Hospital
Shandong, Linyi, China, 276001
Actively Recruiting
35
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
36
Jinan Central Hospital
Jinan, Shandong, China, 250013
Actively Recruiting
37
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
38
Shanghai GoBroad Cancer Hospital
Shanghai, Shanghai Municipality, China, 200125
Actively Recruiting
39
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 611100
Actively Recruiting
40
First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
41
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China, 310016
Actively Recruiting
42
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
43
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
Actively Recruiting
44
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
45
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Actively Recruiting
46
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
47
Adana City Hospital
Adana, Turkey (Türkiye), 01230
Actively Recruiting
48
Hacettepe University Medical Faculty
Ankara, Turkey (Türkiye), 06100
Actively Recruiting
49
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
Ankara, Turkey (Türkiye), 06105
Actively Recruiting
50
Ankara City Hospital
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
51
Yeditepe University Medical School Hospital
Istanbul, Turkey (Türkiye), 31755
Actively Recruiting
52
Koc University Hospital
Istanbul, Turkey (Türkiye), 34010
Actively Recruiting
53
Sakarya Training and Research Hospital
Sakarya, Turkey (Türkiye), 54187
Actively Recruiting
54
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Actively Recruiting
55
St. James's University Hospital
Leeds, United Kingdom, LS97TF
Actively Recruiting
56
St George's Hospitals NHS Foundation Trust
London, United Kingdom, SW170QT
Actively Recruiting
57
University College London Hospital
London, United Kingdom, W1T 7HA
Actively Recruiting
58
The Christie NHS Foundation Trust
Manchester, United Kingdom, M204BX
Actively Recruiting
Research Team
B
BioNTech clinical trials patient information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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