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: 10 Sep 2026

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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

14 Apr 2026 Planned number of patients changed from 280 to 320.
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.

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