Actively Recruiting
A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)
Led by BioNTech SE · Updated on 2026-05-05
420
Participants Needed
68
Research Sites
223 weeks
Total Duration
On this page
Sponsors
B
BioNTech SE
Lead Sponsor
M
MediLink Therapeutics (Suzhou) Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multi-site, open-label, dose-finding study, consisting of Parts 1, 2a, and 2b to investigate the combination of BNT326 with BNT327 in participants with relapsed, progressive as well as treatment-naïve, advanced/metastatic non-small cell lung cancer (NSCLC). This study will enroll adult participants with histologically or cytologically confirmed NSCLC that is advanced (i.e., either metastatic or recurrent tumors with no known curative treatment available).
CONDITIONS
Official Title
A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 618 years at the time of giving informed consent.
- Have measurable disease defined by RECIST v1.1.
- Provide a tumor tissue sample from archival tissue or fresh biopsy unless medically unjustifiable.
- Have Eastern Cooperative Oncology Group performance status of 0 or 1.
- Have adequate organ and bone marrow function within 7 days before enrollment.
- Have advanced (metastatic or locally recurrent, no curative local therapy possible) non-squamous or squamous NSCLC (all cohorts) or only non-squamous NSCLC (Cohort D2).
- For Cohort-specific criteria:
- For AGA-negative NSCLC: no actionable genomic alterations; relapse or progression after 1-3 lines of prior systemic therapy including anti-PD-1/PD-L1 therapy and chemotherapy (limited to 2 lines).
- For AGA-positive NSCLC (excluding EGFR activating mutation): documented positive test for actionable genomic alterations; received 1 or more prior systemic therapies including targeted treatment; progression or intolerance after prior therapy.
- For AGA-positive NSCLC with EGFR activating mutation: positive test for EGFR-sensitizing mutation; received 1-2 prior systemic therapies including approved EGFR TKI; chemotherapy only if combined with EGFR TKI as initial treatment; progression or intolerance after prior therapy.
- For Part 2a Cohort B: no prior systemic anti-cancer treatment for advanced/metastatic disease; may have received neoadjuvant/adjuvant treatment if progression occurred at least 12 months after completion.
- For Part 2b Cohorts C and D: criteria similar to above regarding genomic alterations and prior therapies.
You will not qualify if you...
- Progression on or intolerance to prior HER3-targeting agents or topoisomerase I inhibitor payload treatments (exceptions may apply for Part 2a Cohort A).
- Uncontrolled illnesses that increase risk or limit compliance, including bleeding disorders, active infection, advanced cirrhosis, significant lung disease, oncologic emergencies, psychiatric or substance abuse conditions, or recent severe colitis.
- Left ventricular ejection fraction below 50%.
- Clinically uncontrolled pleural, pericardial, or abdominal fluid requiring drainage within 2 weeks prior to enrollment.
- History or current interstitial lung disease or pneumonitis requiring steroids or suspected but not ruled out by imaging.
- Recent exposure to protocol-specific treatments without required washout.
- Pregnant or breastfeeding participants or those planning pregnancy, and potentially fertile males planning to father children during the study.
- Participation in other investigational studies with exclusion periods.
- Recent small bowel obstruction requiring hospitalization.
- Significant proteinuria.
- History of severe immune-related adverse events leading to discontinuation of prior checkpoint inhibitors.
- Active central nervous system metastases requiring symptom control with steroids or anticonvulsants.
- Significant risk of bleeding or major coagulation disorders.
- Active or chronic corneal disorders preventing adequate drug monitoring.
- Other protocol-defined criteria may apply.
AI-Screening
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Trial Site Locations
Total: 68 locations
1
Stanford Cancer Institute
Stanford, California, United States, 94305
Actively Recruiting
2
Yale University
New Haven, Connecticut, United States, 06511
Actively Recruiting
3
Moffit Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Actively Recruiting
8
University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
9
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
10
Cancer Research SA
Adelaide, Australia, 5000
Actively Recruiting
11
St George Private Hospital
Kogarah, Australia, 2217
Actively Recruiting
12
John Flynn Private Hospital
Tugun, Australia, 4224
Actively Recruiting
13
Westmead Hospital
Westmead, Australia, 2145
Actively Recruiting
14
Affiliated Hospital of Hebei University
Baoding, China, 071000
Actively Recruiting
15
Beijing GoBroad Hospital
Beijing, China, 102200
Actively Recruiting
16
The First Hospital of Jilin University
Changchun, China, 130021
Actively Recruiting
17
West China Hospital, Sichuan University
Chengdu, China, 611135
Actively Recruiting
18
Chongqing University Cancer Hospital
Chongqing, China, 400030
Actively Recruiting
19
The First Affiliated Hospital School of Clinical Medicine of Guangdong Pharmaceutical University
Guangzhou, China, 510080
Actively Recruiting
20
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China, 510163
Actively Recruiting
21
Anhui Chest Hospital
Hefei, China, 230022
Actively Recruiting
22
The First Affiliated Hospital of Anhui Medical University
Hefei, China, 230022
Actively Recruiting
23
Anhui Provincial Cancer Hospital
Hefei, China, 230088
Actively Recruiting
24
The Second Hospital of Anhui Medical University
Hefei, China, 230601
Actively Recruiting
25
Jinan Central Hospital
Jinan, China, 250013
Actively Recruiting
26
The First Affiliated Hospital of Nanchang University
Nanchang, China, 330006
Actively Recruiting
27
The Second Affiliated Hospital of Nanchang University
Nanchang, China, 330006
Actively Recruiting
28
The Affiliated Hospital of Qingdao University
Qingdao, China, 266003
Actively Recruiting
29
Shanghai East Hospital
Shanghai, China, 200120
Actively Recruiting
30
Shanghai GoBroad Cancer Hospital
Shanghai, China, 200120
Actively Recruiting
31
The First Affiliated Hospital of Soochow University
Suzhou, China, 215006
Actively Recruiting
32
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China, 300060
Actively Recruiting
33
Hubei Cancer Hospital
Wuhan, China, 430079
Actively Recruiting
34
Xiangyang Central Hospital
Xiangyang, China, 441138
Actively Recruiting
35
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, China, 453100
Actively Recruiting
36
Northern Jiangsu People's Hospital
Yangzhou, China, 225001
Actively Recruiting
37
Universitätsklinikum Carl Gustav Carus TU Dresden
Dresden, Germany, 01307
Actively Recruiting
38
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
39
Azienda Ospedaliero - Universitaria Nazionale Santi Antonio e Biagio e Cesare Arrigo
Alessandria, Italy, 15100
Actively Recruiting
40
Azienda Ospedaliera Universitaria Careggi
Florence, Italy, 50134
Actively Recruiting
41
Institute of Oncology, ARENSIA Exploratory Medicine
Chisinau, Moldova, 2025
Actively Recruiting
42
Pratia MCM Krakow
Krakow, Poland, 30-727
Actively Recruiting
43
Centrum Medyczne Pratia Poznan
Poznan, Poland, 60-192
Actively Recruiting
44
Med-Polonia Sp. z o.o.
Poznan, Poland, 60-693
Actively Recruiting
45
Provita Prolife
Tomaszów Mazowiecki, Poland, 97-200
Actively Recruiting
46
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
47
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
48
Hospital Universitario HM Madrid Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
49
Clinica Universidad de Navarra
Madrid, Spain, 31008
Actively Recruiting
50
Hospital Quironsalud Malaga
Málaga, Spain, 29004
Actively Recruiting
51
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
52
Medical Park Seyhan Hospital
Adana, Turkey (Türkiye), 01140
Actively Recruiting
53
Adana City Hospital
Adana, Turkey (Türkiye), 01230
Actively Recruiting
54
Baskent University Adana Application and Research Center
Adana, Turkey (Türkiye), 01240
Actively Recruiting
55
Hacettepe University Medical Faculty
Ankara, Turkey (Türkiye), 06100
Actively Recruiting
56
Dr. Abdurrahman Yurtaslan Ankara Oncology Research and Training Hospital, Clinical Research Center
Ankara, Turkey (Türkiye), 06105
Actively Recruiting
57
Gazi University Medical Faculty
Ankara, Turkey (Türkiye), 06500
Actively Recruiting
58
Ankara Memorial Hospital
Ankara, Turkey (Türkiye), 06520
Actively Recruiting
59
Memorial Antalya Hastanesi
Antalya, Turkey (Türkiye), 07020
Actively Recruiting
60
Yeditepe University Medical School Hospital
Istanbul, Turkey (Türkiye), 31755
Actively Recruiting
61
Koc University Hospital
Istanbul, Turkey (Türkiye), 34010
Actively Recruiting
62
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, Turkey (Türkiye), 34722
Actively Recruiting
63
Mersin City Education and Research Hospital
Mersin, Turkey (Türkiye), 33330
Actively Recruiting
64
Sakarya Training and Research Hospital
Sakarya, Turkey (Türkiye), 54290
Actively Recruiting
65
Royal Free Hospital
London, United Kingdom, NW3 2QG
Actively Recruiting
66
Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Actively Recruiting
67
Northern Centre for Cancer Care
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
68
Royal Marsden Hospital-Sutton
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
B
BioNTech clinical trials patient information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
15
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