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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: Recruiting Phase 1 study of Non-Small Cell Lung Cancer, sponsored by BioNTech SE.
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 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (57% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cohort EGFR and Cohort ALK/RET will enroll only at selected sites in the US.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2022-06-17 |
| Est. Completion | 2031-11 |
| Phase | Phase 1 |
What NCT05142189 shows while recruiting
NCT05142189 is an interventional study that assigns participants to a tested intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (57% lower).
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 names 20 study sites across 8 states, led by 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.
Learn More About Clinical Trials
Similar trials for Non-Small Cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05142189's enrollment target sits among peer trials
280 133rd of 454 higher than 321 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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