RecruitingPhase 1NCT05142189

Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer

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

Sponsor

BioNTech SE

Enrollment

320 participants

Start Date

Jun 17, 2022

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new cancer vaccine called BNT116, alone or combined with other treatments, in people with advanced non-small cell lung cancer (NSCLC). The vaccine is designed to teach the immune system to recognize and attack lung cancer cells. Multiple treatment combinations are being tested across different patient groups (cohorts). **You may be eligible if...** - You have been diagnosed with advanced or metastatic non-small cell lung cancer (Stage III or IV) - You are in good enough health to participate (ECOG performance score of 0–2) - You have not had certain treatments recently, or you fall into a specific cohort that matches your prior treatment history - You can tolerate immune checkpoint therapy (anti-PD-1 drugs) if required for your cohort **You may NOT be eligible if...** - You are currently receiving active treatment for your lung cancer - Your cancer has a targetable gene mutation (like EGFR or ALK) and you have not tried the approved targeted therapy - You have an active autoimmune disease that required strong immune-suppressing medications in the last 5 years - You have growing or new brain or spinal metastases - You are on high-dose chronic steroids or other immune-suppressing drugs - You have HIV with a low immune cell count or have had AIDS-related infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALBNT116

Intravenous injection

BIOLOGICALCemiplimab

Intravenous infusion

DRUGDocetaxel

Intravenous infusion

DRUGCarboplatin

Intravenous infusion

DRUGPaclitaxel

Intravenous infusion

BIOLOGICALBNT316

Intravenous infusion

BIOLOGICALanti-B7-H3 antibody conjugated to topoisomerase I inhibitor

Intravenous infusion

BIOLOGICALanti-HER3 antibody conjugated to topoisomerase I inhibitor

Intravenous infusion

BIOLOGICALBispecific antibody for PD-L1 and VEGF-A

Intravenous infusion

BIOLOGICALOsimertinib

Oral

BIOLOGICALALK-inhibitor or RET-inhibitor

Oral

Locations(44)

University of Kentucky Chandler Medical Center

Lexington, Kentucky, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

MD Anderson Cancer Center

Houston, Texas, United States

NEXT Virginia

Fairfax, Virginia, United States

Scientia Clinical Research

Randwick, New South Wales, Australia

Royal North Shore Hospital

Sydney, New South Wales, Australia

Cancer Research SA

Adelaide, South Australia, Australia

Monash Health

Clayton, Victoria, 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05142189

Related Trials

Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC)

NCT066944541 location

A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)

NCT06077760229 locations

A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)

NCT06312137260 locations

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

NCT06692738301 locations

A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)

NCT06345729216 locations