Actively Recruiting
A Phase Ib/II, Multi-site, Open-label, Dose Finding Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT326 in Combination With BNT327 in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)
Led by BioNTech SE · Updated on 2026-05-05
420
Participants Needed
68
Research Sites
52 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
Researchers are evaluating the combination of two investigational drugs, BNT326 and BNT327, in adults with advanced or metastatic non-small cell lung cancer (NSCLC) that has either relapsed, progressed, or is treatment-na efve. The study aims to find safe dosage levels and assess the safety, preliminary efficacy, and tolerability of this combination therapy. It involves participants with histologically or cytologically confirmed NSCLC without curative treatment options. The trial has several parts: Part 1 focuses on dose escalation to establish safe dose levels of BNT326 combined with BNT327. Part 2a expands to evaluate preliminary effectiveness and safety, enrolling participants with different treatment histories. Part 2b involves dose optimization and compares treatments in randomized cohorts. Participants receive intravenous infusions of the study drugs and may also receive pembrolizumab or standard chemotherapy depending on their cohort. Dosing decisions for later cohorts are based on earlier study data. Participants will go through screening, treatment, safety follow-up, efficacy follow-up, and long-term survival follow-up periods. Treatments continue until disease progression, unacceptable side effects, withdrawal, study end, or a maximum of 24 months. Researchers will monitor dose-limiting toxicities, adverse events, treatment responses, progression-free survival, and overall survival over about 36 months. Blood samples will be collected for pharmacokinetic and antibody assessments. Participants' health and disease status will be regularly assessed by imaging and clinical evaluations throughout the study.
CONDITIONS
Brief 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...
- Age 18 years or older at the time of informed consent
- Measurable disease defined by RECIST v1.1
- Ability to provide tumor tissue sample from archival tissue or fresh biopsy unless medically unjustifiable
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate organ and bone marrow function within 7 days before enrollment
- Advanced (metastatic or locally recurrent without curative intent) non-squamous or squamous NSCLC (all cohorts) or only non-squamous NSCLC (Cohort D2)
- Specific cohort criteria including prior treatment lines, actionable genomic alterations, and PD-L1 status as detailed in the protocol
- For patients with EGFR activating mutation: prior EGFR TKI treatments as specified and progression or intolerance to prior therapies
You will not qualify if you...
- Disease progression on or intolerance to prior HER3-targeting agents or topoisomerase I inhibitor payloads (with some exceptions in Part 2a Cohort A)
- Uncontrolled illnesses that increase risk or limit study compliance including bleeding, active infections, severe liver cirrhosis, significant pulmonary disease, oncologic emergencies, psychiatric or abuse conditions, and recent severe colitis
- Left ventricular ejection fraction below 50%
- Clinically uncontrolled pleural, pericardial effusions, or ascites requiring intervention within 2 weeks before enrollment
- History or current interstitial lung disease or pneumonitis requiring steroids, or suspected ILD/pneumonitis not ruled out by imaging
- Recent exposure to protocol-specific treatments without required washout
- Pregnancy, breastfeeding, planned pregnancy, or fertile males planning conception during study or within protocol timeframes
- Participation in other investigational studies requiring exclusion periods
- History of small bowel obstruction requiring hospitalization in past 3 months
- Significant proteinuria as defined in protocol
- History of severe immune-related adverse events leading to prior treatment discontinuation
- Clinically active, untreated, or symptomatic central nervous system metastases
- Significant hemorrhage risk or coagulation disorders
- Active or chronic corneal disorders preventing adequate monitoring of drug-induced eye effects
- Other protocol-defined criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive combination therapy with BNT326 and BNT327 or comparator drugs depending on their cohort and randomization. Treatment continues until disease progression, withdrawal, unacceptable toxicity, or up to 24 months.
Visits occur regularly for infusions and monitoring during treatment period
Duration - Approximately 3 months
Participants are monitored for safety outcomes including adverse events and pharmacokinetics for approximately 90 days after the last dose of treatment.
Multiple visits for safety assessments post-treatment
Duration - Up to 36 months from treatment start
Participants are followed to assess efficacy outcomes such as response rate and survival for up to approximately 36 months from treatment start.
Periodic visits for efficacy assessments
Duration - Up to approximately 36 months total
Participants are monitored long-term for survival outcomes after completion of treatment and follow-up periods.
Visits may occur periodically depending on participant status
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
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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