Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony rozpoznaniem histologicznym rak płuca typu nie-drobnokomórkowy
- •Stan ogólny pacjenta (ECOG) 0-2, w zależności od grupy badawczej
- •Zaawansowana lub przerzutowa choroba (stadium III-IV), w niektórych grupach stadium II-III lub nieresekcyjne stadium III
- •W wybranych grupach poprzednia terapia zawierająca inhibitor PD-1/PD-L1 i chemioterapię platynową
- •Zmierzone ogniska choroby dostępne do oceny (w wybranych grupach nie wymagane)
- •W wybranych grupach możliwość toleracji dodatkowej immunoterapii
- •Ekspresja PD-L1 (w wybranych grupach) ≥1% w komórkach nowotworu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 22, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (45)
University of Kentucky Chandler Medical Center
Lexington, United States
Norton Cancer Institute
Louisville, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, United States
Ohio State University
Columbus, United States
MD Anderson Cancer Center
Houston, United States
NEXT Virginia
Fairfax, United States
Scientia Clinical Research
Randwick, Australia
Royal North Shore Hospital
Sydney, Australia
Cancer Research SA
Adelaide, Australia
Monash Health
Clayton, Australia
Universitätsklinikum Köln
Cologne, Germany
Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)
Frankfurt, Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz, Germany
ICON-PRA Budapest, Fázis 1 Vizsgálóhely
Budapest, Hungary
Semmelweis Egyetem ÁOK Belgyógyászati és Onkológiai Klinika
Budapest, Hungary
National Institute of Oncology
Budapest, Hungary
Clinexpert Ltd
Gyöngyös, Hungary
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie
Olsztyn, Poland
NZOZ Medpolonia Sp. Z o.o
Poznan, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, Poland
Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol
Badalona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
MD Anderson Cancer Center
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
START Madrid - CIOCC. Grupo Hospital de Madrid (HM) - Centro Integral Oncologico Clara Campal (CIOCC)
Madrid, Spain
Complejo Hospitalario Universitario de Santiago de Compostela (CHUS) - Hospital Clinico Universitario (University Clinical Hospital)
Santiago de Compostela, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Universitario y Politecnico La Fe
Valencia, Spain
Adana City Training and Research Hospital
Adana, Turkey (Türkiye)
Haceteppe Hospital
Ankara, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, Turkey (Türkiye)
Ankara City Hospital
Ankara, Turkey (Türkiye)
Koc University Hospital
Istanbul, Turkey (Türkiye)
University Medical Faculty Oncology Institute
Istanbul, Turkey (Türkiye)
Yeditepe University
Istanbul, Turkey (Türkiye)
Ege University School of Medicine Tulay Aktas Oncology Hospital
Izmir, Turkey (Türkiye)
Dokuz Eylul Medical School
Izmir, Turkey (Türkiye)
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Velindre NHS Trust
Cardiff, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom
Guy's and St Thomas NHS Foundation Trust
London, United Kingdom
University College London Hospitals NHS Foundation Trust
London, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom
Trial contact
BioNTech clinical trials patient information
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/23/2026.
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