NCT05142189

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

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: Phase 1
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This first-in-human (FIH) study 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, osimertinib, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs), rearranged during transfection (RET) TKIs, 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 study will comprise several cohorts for dose confirmation in monotherapy as well as in combinations of BNT116 as mentioned above. The study 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, resectable NSCLC of Stage II and III in Cohort 6, advanced/metastatic epidermal growth factor receptor (EGFR)-mutant NSCLC in Cohort EGFR, and advanced/metastatic ALK rearranged or RET rearranged NSCLC in Cohort ALK/RET. Cohort EGFR and Cohort ALK/RET will enroll only at selected sites in the US.

Detailed description

The maximum duration of treatment for each individual participant in this study is: * Cohorts 1 to 4, Cohorts 7 to 10, Cohort EGFR, and Cohort ALK/RET: 24 months. * Cohorts 5 and 11: 18 cycles, i.e., 12 months. * Cohort 6: 4 cycles of neo-adjuvant treatment and 18 cycles of adjuvant treatment, i.e., 12 months of adjuvant treatment.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	BNT116	Intravenous injection
BIOLOGICAL	Cemiplimab	Intravenous infusion
DRUG	Docetaxel	Intravenous infusion
DRUG	Carboplatin	Intravenous infusion
DRUG	Paclitaxel	Intravenous infusion
BIOLOGICAL	BNT316	Intravenous infusion
BIOLOGICAL	anti-B7-H3 antibody conjugated to topoisomerase I inhibitor	Intravenous infusion
BIOLOGICAL	anti-HER3 antibody conjugated to topoisomerase I inhibitor	Intravenous infusion
BIOLOGICAL	Bispecific antibody for PD-L1 and VEGF-A	Intravenous infusion
BIOLOGICAL	Osimertinib	Oral
BIOLOGICAL	ALK-inhibitor or RET-inhibitor	Oral

Timeline

• Start date: 2022-06-17
• Primary completion: 2030-02-01
• Completion: 2031-11-01
• First posted: 2021-12-02
• Last updated: 2026-04-14

Locations

44 sites across 8 countries: United States, Australia, Germany, Hungary, Poland, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study