Spots Global Cancer Trial Database for Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
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Trial Identification
Brief 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
Official Title: LuCa-MERIT-1: First-in-human, Open Label, Phase I Dose Confirmation Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
Study ID: NCT05142189
Conditions
Study Description
Brief Summary: This First-in-human (FIH) trial for BNT116 aims to establish the safety profile and a safe dose for BNT116 monotherapy as well as for BNT116 in combination with cemiplimab or docetaxel in patients with advanced or metastasized non-small cell lung cancer (NSCLC) and unresectable NSCLC after chemoradiotherapy (CRT). Furthermore, the trial aims to establish the safety and feasibility of BNT116 in combination with cemiplimab and chemotherapy (carboplatin+paclitaxel) as neo-adjuvant treatment in resectable NSCLC followed by surgery and adjuvant BNT116 + cemiplimab. The trial will comprise several cohorts for dose confirmation in monotherapy as well as in combinations of BNT116 as mentioned above.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Norton Cancer Institute, Louisville, Kentucky, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
NEXT Virginia, Fairfax, Virginia, United States
Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF), Frankfurt, , Germany
University Medical Center Hamburg-Eppendorf, Hamburg, , Germany
Universitätsklinikum Köln, Köln, , 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, Gyongyos, , Hungary
Uniwersyteckie Centrum Kliniczne, Gdańsk, , Poland
Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie, Olsztyn, , Poland
NZOZ Medpolonia Sp. Z o.o, Poznań, , 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, Sevilla, , Spain
Hospital Universitario y Politecnico La Fe, Valencia, , Spain
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Ankara, , Turkey
Ankara City Hospital, Ankara, , Turkey
Yeditepe University, Istanbul, , Turkey
Ege University School of Medicine Tulay Aktas Oncology Hospital, Izmir, , Turkey
Dokuz Eylul Medical School, İzmir, , Turkey
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
Contact Details
Name: BioNTech Responsible Person
Affiliation: BioNTech SE
Role: STUDY_DIRECTOR
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