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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 11 Oct 2025

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At a glance

  • Drugs BNT 116 (Primary) ; Carboplatin (Primary) ; Cemiplimab (Primary) ; Docetaxel (Primary)
  • Indications Non-small cell lung cancer
  • Focus Adverse reactions; First in man
  • Acronyms LuCa-MERIT-1
  • Sponsors BioNTech

Most Recent Events

  • 23 Sep 2025 Planned number of patients changed from 220 to 280.
  • 04 Aug 2025 According to the BioNTech media release, Data from a cohort from the LuCa-MERIT-1 clinical trial evaluating BNT116 in combination with cemiplimab in patients with NSCLC who have received chemoradiotherapy will be provided in a mini-oral session at the 2025 World Conference on Lung Cancer (WCLC) in Barcelona, Spain, September 6-9, 2025.
  • 04 Aug 2025 According to the BioNTech media release, In May, the first patient was dosed in a new cohort in the LuCa-MERIT-1 clinical trial to evaluate BNT116 in combination with BNT324/DB-1311.

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