Actively Recruiting
Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
Led by BioNTech SE · Updated on 2026-04-14
320
Participants Needed
44
Research Sites
489 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This first-in-human (FIH) study for BNT116 aims to establish the safety profile and a safe dose for BNT116 monotherapy as well as for BNT116 in combination with approved medicinal products and/or in combination with investigational medicinal products (IMPs) including, but not limited to, cemiplimab, docetaxel, carboplatin, paclitaxel, osimertinib, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs), rearranged during transfection (RET) TKIs, BNT316 (an anti-cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\] antibody), an anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor, an anti-human epidermal growth factor receptor 3 (HER3) antibody conjugated to a topoisomerase I inhibitor or a bispecific antibody for programmed death ligand 1 (PD-L1) and vascular endothelial growth factor A (VEGF-A) in participants with non-small cell lung cancer (NSCLC). The study will comprise several cohorts for dose confirmation in monotherapy as well as in combinations of BNT116 as mentioned above. The study will enroll participants with NSCLC in advanced or metastatic stage in Cohorts 1 to 4 and Cohorts 7 to 10, unresectable NSCLC Stage III in Cohorts 5 and 11, resectable NSCLC of Stage II and III in Cohort 6, advanced/metastatic epidermal growth factor receptor (EGFR)-mutant NSCLC in Cohort EGFR, and advanced/metastatic ALK rearranged or RET rearranged NSCLC in Cohort ALK/RET. Cohort EGFR and Cohort ALK/RET will enroll only at selected sites in the US.
CONDITIONS
Official Title
Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have histologically confirmed NSCLC.
- Participants must have unresectable Stage III or metastatic Stage IV NSCLC, except specified cohorts.
- Participants in Cohorts 5 and 11 must have unresectable Stage III NSCLC before chemoradiotherapy.
- Participants in Cohort 6 must have resectable Stage II or III NSCLC.
- Participants must have measurable disease by RECIST v1.1 except in Cohorts 1, 5, and 11.
- Participants must have ECOG performance status 0-1, except Cohorts 1, 4, 5, 10, and 11 allow 0-2.
- Participants in certain cohorts must tolerate anti-PD-1 therapy without permanent discontinuation due to toxicity.
- Cohort 1 participants must have prior PD-1/PD-L1 inhibitor and platinum chemotherapy and one other systemic therapy or be ineligible for these.
- Cohort 1 participants starting cemiplimab must have PD-L1 TPS ≥1%.
- Cohort 2 participants must have PD-L1 TPS ≥50% and progressive disease after specified treatments.
- Cohort 3 participants must have prior PD-1/PD-L1 inhibitor and platinum chemotherapy and progressive disease.
- Cohort 4 participants not candidates for chemotherapy must have PD-L1 TPS ≥1%.
- Cohort 5 participants must have unresectable NSCLC and prior chemoradiotherapy.
- Cohort 6 participants must be eligible for neo-adjuvant treatment.
- Cohort 7 participants must have prior PD-1/PD-L1 inhibitor and platinum chemotherapy and progressive disease.
- Cohorts 8 and 9 participants must have prior PD-1/PD-L1 inhibitor and platinum chemotherapy and progressive disease.
- Cohort 10 participants not candidates for chemotherapy may enroll.
- Cohort 11 participants must have unresectable NSCLC and prior chemoradiotherapy.
- Cohort EGFR participants must have EGFR mutations and ongoing osimertinib treatment.
- Cohort ALK/RET participants must have ALK or RET rearrangement and ongoing standard ALK or RET TKI treatment.
You will not qualify if you...
- Ongoing active systemic treatment against NSCLC.
- Presence of driver mutations with approved targeted therapies unless ineligible, except Cohorts EGFR and ALK/RET.
- Active autoimmune disease requiring systemic immunosuppressive treatment within the last 5 years.
- Known brain or spinal metastases unless treated, stable, symptom-free, and off steroids as specified, except in some cohorts.
- Current use of systemic steroids above 5 mg/day prednisolone equivalent unless for adrenal or pituitary insufficiency.
- Other relevant systemic immune suppression within 3 months before enrollment.
- History of HIV with low CD4 counts and AIDS-defining infections.
- Prior splenectomy.
- History or risk of interstitial lung disease or low baseline lung function (oxygen saturation <92% without oxygen).
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 44 locations
1
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
2
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
Actively Recruiting
3
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
5
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
6
Scientia Clinical Research
Randwick, New South Wales, Australia, 2031
Actively Recruiting
7
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
Actively Recruiting
8
Cancer Research SA
Adelaide, South Australia, Australia, 5000
Actively Recruiting
9
Monash Health
Clayton, Victoria, Australia, 3168
Actively Recruiting
10
Universitätsklinikum Köln
Cologne, Germany, 50937
Actively Recruiting
11
Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)
Frankfurt, Germany, 60488
Actively Recruiting
12
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
13
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz, Germany, 55131
Actively Recruiting
14
ICON-PRA Budapest, Fázis 1 Vizsgálóhely
Budapest, Hungary, 1077
Completed
15
Semmelweis Egyetem ÁOK Belgyógyászati és Onkológiai Klinika
Budapest, Hungary, 1083
Actively Recruiting
16
National Institute of Oncology
Budapest, Hungary, 1122
Actively Recruiting
17
Clinexpert Ltd
Gyöngyös, Hungary, 3200
Actively Recruiting
18
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-214
Actively Recruiting
19
Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie
Olsztyn, Poland, 10-357
Actively Recruiting
20
NZOZ Medpolonia Sp. Z o.o
Poznan, Poland, 60-693
Actively Recruiting
21
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, Poland, 02-781
Withdrawn
22
Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol
Badalona, Spain, 08916
Actively Recruiting
23
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
24
MD Anderson Cancer Center
Madrid, Spain, 28033
Actively Recruiting
25
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
26
START Madrid - CIOCC. Grupo Hospital de Madrid (HM) - Centro Integral Oncologico Clara Campal (CIOCC)
Madrid, Spain, 28050
Actively Recruiting
27
Complejo Hospitalario Universitario de Santiago de Compostela (CHUS) - Hospital Clinico Universitario (University Clinical Hospital)
Santiago de Compostela, Spain, 15706
Actively Recruiting
28
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
29
Hospital Universitario y Politecnico La Fe
Valencia, Spain, 46026
Actively Recruiting
30
Adana City Training and Research Hospital
Adana, Turkey (Türkiye), 01370
Actively Recruiting
31
Haceteppe Hospital
Ankara, Turkey (Türkiye), 06100
Actively Recruiting
32
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, Turkey (Türkiye), 06200
Actively Recruiting
33
Ankara City Hospital
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
34
Koc University Hospital
Istanbul, Turkey (Türkiye), 34010
Actively Recruiting
35
University Medical Faculty Oncology Institute
Istanbul, Turkey (Türkiye), 34093
Actively Recruiting
36
Yeditepe University
Istanbul, Turkey (Türkiye), 34718
Actively Recruiting
37
Ege University School of Medicine Tulay Aktas Oncology Hospital
Izmir, Turkey (Türkiye), 35100
Actively Recruiting
38
Dokuz Eylul Medical School
Izmir, Turkey (Türkiye), 35330
Completed
39
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
40
Velindre NHS Trust
Cardiff, United Kingdom, CF14 2TL
Actively Recruiting
41
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom, L7 8YA
Actively Recruiting
42
Guy's and St Thomas NHS Foundation Trust
London, United Kingdom, SE1 9RT
Actively Recruiting
43
University College London Hospitals NHS Foundation Trust
London, United Kingdom, W1T 7HA
Actively Recruiting
44
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
Research Team
B
BioNTech clinical trials patient information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
14
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