ClinicalTrials.gov record
Recruiting Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT05142189

Public ClinicalTrials.gov record NCT05142189. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 6, 2026, 8:51 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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 identification

NCT ID
NCT05142189
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
BioNTech SE
Industry
Enrollment
320 participants

Conditions and interventions

Interventions

  • ALK-inhibitor or RET-inhibitor Biological
  • BNT116 Biological
  • BNT316 Biological
  • Bispecific antibody for PD-L1 and VEGF-A Biological
  • Carboplatin Drug
  • Cemiplimab Biological
  • Docetaxel Drug
  • Osimertinib Biological
  • Paclitaxel Drug
  • anti-B7-H3 antibody conjugated to topoisomerase I inhibitor Biological
  • anti-HER3 antibody conjugated to topoisomerase I inhibitor Biological

Biological · Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 16, 2022
Primary completion
Jan 31, 2030
Completion
Oct 31, 2031
Last update posted
Apr 13, 2026

2022 – 2031

United States locations

U.S. sites
5
U.S. states
4
U.S. cities
5
Facility City State ZIP Site status
University of Kentucky Chandler Medical Center Lexington Kentucky 40536 Recruiting
Norton Cancer Institute Louisville Kentucky 40202 Recruiting
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland 21287 Recruiting
MD Anderson Cancer Center Houston Texas 77030 Recruiting
NEXT Virginia Fairfax Virginia 22031 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 39 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05142189, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 13, 2026 · Synced May 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05142189 live on ClinicalTrials.gov.

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