{"commentary":{"count":3,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":3},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":false},"name":"LuCa-MERIT-1","nct_id":"NCT05142189","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=luca-merit-1-nct05142189. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–12 commentary sources"},"registry":{"acronym":"LuCa-MERIT-1","arms":[{"description":null,"label":"Cohort 1A - BNT116 Monotherapy","type":"EXPERIMENTAL"},{"description":null,"label":"Cohort 1B - BNT116 Monotherapy","type":"EXPERIMENTAL"},{"description":null,"label":"Cohort 2 - BNT116 + Cemiplimab (PD-1/PD-L1 Inhibitor Refractory/Relapsed Participants)","type":"EXPERIMENTAL"},{"description":null,"label":"Cohort 3 - BNT116 + Docetaxel","type":"EXPERIMENTAL"},{"description":null,"label":"Cohort 4 - BNT116 + Cemiplimab (Frail Participants)","type":"EXPERIMENTAL"},{"description":null,"label":"Cohort 5 - BNT116 + Cemiplimab (After Concurrent Chemoradiotherapy [CRT])","type":"EXPERIMENTAL"},{"description":"BNT116 + cemiplimab + carboplatin + paclitaxel as neo-adjuvant treatment followed by surgery, thereafter adjuvant treatment with BNT116 + cemiplimab","label":"Cohort 6 - BNT116 + Cemiplimab + Carboplatin + Paclitaxel","type":"EXPERIMENTAL"},{"description":"Dose finding for the combination of BNT116 with BNT316 (CTLA4 antibody) with dose escalation of BNT316","label":"Cohort 7 - BNT116 + BNT316","type":"EXPERIMENTAL"},{"description":"Dose finding for the combination of BNT116 with an anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor with dose escalation of the anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor","label":"Cohort 8: BNT116 + Anti-B7-H3 Antibody Conjugated to Topoisomerase I Inhibitor","type":"EXPERIMENTAL"},{"description":"Dose confirmation for the combination of BNT116 with an anti-HER3 antibody conjugated to a topoisomerase I inhibitor with dose escalation of the anti-HER3 antibody conjugated to a topoisomerase I inhibitor","label":"Cohort 9: BNT116 + Anti-HER3 Antibody Conjugated to Topoisomerase I Inhibitor","type":"EXPERIMENTAL"},{"description":"Dose confirmation for BNT116 in combination with a bispecific antibody for programmed death ligand 1 (PD-L1) and vascular endothelial growth factor A (VEGF-A) will be established.","label":"Cohort 10: BNT116 + Bispecific Antibody for PD-L1 and VEGF-A (Frail Participants)","type":"EXPERIMENTAL"},{"description":"Dose confirmation for BNT116 in combination with a bispecific antibody for PD-L1 and VEGF-A will be established in participants after concurrent CRT.","label":"Cohort 11: BNT116 + Bispecific Antibody for PD-L1 and VEGF-A (After Concurrent CRT)","type":"EXPERIMENTAL"},{"description":"Dose confirmation for BNT116 in combination with ongoing osimertinib therapy. Treatment with osimertinib is standard of care.\n\nCohort will enroll only at selected sites in the US.","label":"Cohort EGFR : BNT116 + osimertinib","type":"EXPERIMENTAL"},{"description":"Dose confirmation for BNT116 in combination with either ongoing ALK-inhibitor or ongoing RET-inhibitor therapy. Treatment with ALK TKI or RET TKI is standard of care.\n\nCohort will enroll only at selected sites in the US.","label":"Cohort ALK/RET: BNT116 + ALK TKI or RET TKI","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2031-11","type":"ESTIMATED"},"conditions":["Non-Small Cell Lung Cancer"],"enrollment":{"count":320,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"BNT116","type":"BIOLOGICAL"},{"name":"Cemiplimab","type":"BIOLOGICAL"},{"name":"Docetaxel","type":"DRUG"},{"name":"Carboplatin","type":"DRUG"},{"name":"Paclitaxel","type":"DRUG"},{"name":"BNT316","type":"BIOLOGICAL"},{"name":"anti-B7-H3 antibody conjugated to topoisomerase I inhibitor","type":"BIOLOGICAL"},{"name":"anti-HER3 antibody conjugated to topoisomerase I inhibitor","type":"BIOLOGICAL"},{"name":"Bispecific antibody for PD-L1 and VEGF-A","type":"BIOLOGICAL"},{"name":"Osimertinib","type":"BIOLOGICAL"},{"name":"ALK-inhibitor or RET-inhibitor","type":"BIOLOGICAL"}],"last_update":"2026-07-22","lead_sponsor":"BioNTech SE","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","overall_status":"RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2030-02","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Cohorts 1, 2, 3, 4, 6, 7, 8, 9, 10, 11, EGFR and ALK/RET: Occurrence of Dose-Limiting Toxicities (DLTs) During the DLT Observation Period","timeFrame":"From first dose of IMP up to 21 days"},{"measure":"Cohorts 1 to 11, EGFR and ALK/RET: Occurrence of Treatment-Emergent Adverse Events (TEAEs) Reported by Relationship, Seriousness, and Grade","timeFrame":"up to 27 months"},{"measure":"Cohort 6 only: Occurrence of Post-Surgical Adverse Events (AEs) Related to BNT116 and Cemiplimab","timeFrame":"up to 27 months"},{"measure":"Cohort 6 only: Occurrence of Treatment-Related Delays to Surgery More Than 9 weeks Post the Last Dose of Neo-Adjuvant Treatment","timeFrame":"up to 6 months"}],"references":[],"start_date":{"date":"2022-06-17","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer","url":"https://clinicaltrials.gov/study/NCT05142189"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/luca-merit-1-nct05142189"}