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NCT05142189 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Non-Small Cell Lung Cancer, sponsored by BioNTech SE.

Recruiting
Registry status
Phase 1
Development phase
280
Enrollment target
20
Study locations

NCT05142189 is a Phase 1 study of Non-Small Cell Lung Cancer that is actively recruiting participants, run by BioNTech SE. The registered enrollment target is 280 participants, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (57% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT05142189, a Phase 1 study of Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by BioNTech SE.

RECRUITING
Registry status
Phase 1
Development phase
280 participants
Enrollment target
20
Study locations

Study 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 approved medicinal products and/or in combination with investigational medicinal products (IMPs) including, but not limited to, cemiplimab, docetaxel, carboplatin, paclitaxel, 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 trial will comprise of several cohorts for dose confirmation in monotherapy as well as in combinations of BNT116 as mentioned above. The trial 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, and resectable NSCLC of Stage II and III in Cohort 6.

Conditions Studied

Non-Small Cell Lung Cancer

Interventions

  • DRUG Carboplatin
  • DRUG Docetaxel
  • DRUG Paclitaxel
  • BIOLOGICAL Cemiplimab
  • BIOLOGICAL BNT116

Study Locations (20)

Other

  • Universitätsklinikum Köln - Cologne
  • Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF) - Frankfurt
  • University Medical Center Hamburg-Eppendorf - Hamburg
  • Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR - Mainz
  • ICON-PRA Budapest, Fázis 1 Vizsgálóhely - Budapest
  • Semmelweis Egyetem ÁOK Belgyógyászati és Onkológiai Klinika - Budapest
  • National Institute of Oncology - Budapest
  • Clinexpert Ltd - Gyöngyös
  • Uniwersyteckie Centrum Kliniczne - Gdansk
  • Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie - Olsztyn
  • NZOZ Medpolonia Sp. Z o.o - Poznan

Kentucky

  • University of Kentucky Chandler Medical Center - Lexington
  • Norton Cancer Institute - Louisville

New South Wales

  • Scientia Clinical Research - Randwick
  • Royal North Shore Hospital - Sydney

Maryland

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center - Baltimore

Texas

  • MD Anderson Cancer Center - Houston

Virginia

  • NEXT Virginia - Fairfax

South Australia

  • Cancer Research SA - Adelaide

Victoria

  • Monash Health - Clayton

Trial Details

FieldValue
Enrollment Target 280 participants
Start Date 2022-06-17
Est. Completion 2031-11
Phase Phase 1

Sponsor

BioNTech SE

53 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05142189

The ClinicalTrials.gov registry entry for NCT05142189 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (57% lower). The listed sponsor is BioNTech SE, which has 53 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.

NCT05142189 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Other, Kentucky, New South Wales.

Frequently Asked Questions

What is clinical trial NCT05142189 about?

NCT05142189 is a clinical study titled "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 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 approved medicinal products and/or in combination with investigational medicinal products (IMPs) including, but not limited to, cemiplimab,...

What is the current status of trial NCT05142189?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 280 participants. The study started on 2022-06-17. Estimated completion is 2031-11.

What conditions does trial NCT05142189 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.

What interventions are being tested in trial NCT05142189?

The interventions under investigation include: Carboplatin (DRUG), Docetaxel (DRUG), Paclitaxel (DRUG), Cemiplimab (BIOLOGICAL), BNT116 (BIOLOGICAL).

Who is sponsoring clinical trial NCT05142189?

This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05142189 being conducted?

This trial has 20 study locations across Kentucky, Maryland, Texas, Virginia, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.