Clinical trial · no report yet · Phase 1
LuCa-MERIT-1
Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
- NCT05142189 ↗
- Recruiting
- BioNTech SE
- 3 commentary sources found
- Focused
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Commentary we found
Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built. Commentary is thin so far, so the report would be short.
| Channel | Found | |
|---|---|---|
| X threads | 3 |
The trial
ClinicalTrials.gov- 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
- Phase
- Phase 1
- Status
- Recruiting
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- BNT116; Cemiplimab; Docetaxel; Carboplatin; Paclitaxel; BNT316; anti-B7-H3 antibody conjugated to topoisomerase I inhibitor; anti-HER3 antibody conjugated to topoisomerase I inhibitor; Bispecific antibody for PD-L1 and VEGF-A; Osimertinib; ALK-inhibitor or RET-inhibitor
- Arms
- Cohort 1A - BNT116 Monotherapy · Experimental
- Cohort 1B - BNT116 Monotherapy · Experimental
- Cohort 2 - BNT116 + Cemiplimab (PD-1/PD-L1 Inhibitor Refractory/Relapsed Participants) · Experimental
- Cohort 3 - BNT116 + Docetaxel · Experimental
- Cohort 4 - BNT116 + Cemiplimab (Frail Participants) · Experimental
- Cohort 5 - BNT116 + Cemiplimab (After Concurrent Chemoradiotherapy [CRT]) · Experimental
- Cohort 6 - BNT116 + Cemiplimab + Carboplatin + Paclitaxel · Experimental
- Cohort 7 - BNT116 + BNT316 · Experimental
- Cohort 8: BNT116 + Anti-B7-H3 Antibody Conjugated to Topoisomerase I Inhibitor · Experimental
- Cohort 9: BNT116 + Anti-HER3 Antibody Conjugated to Topoisomerase I Inhibitor · Experimental
- Cohort 10: BNT116 + Bispecific Antibody for PD-L1 and VEGF-A (Frail Participants) · Experimental
- Cohort 11: BNT116 + Bispecific Antibody for PD-L1 and VEGF-A (After Concurrent CRT) · Experimental
- Cohort EGFR : BNT116 + osimertinib · Experimental
- Cohort ALK/RET: BNT116 + ALK TKI or RET TKI · Experimental
- Enrollment
- 320 (estimated)
- Primary outcomes
- 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
- Cohorts 1 to 11, EGFR and ALK/RET: Occurrence of Treatment-Emergent Adverse Events (TEAEs) Reported by Relationship, Seriousness, and Grade
- Cohort 6 only: Occurrence of Post-Surgical Adverse Events (AEs) Related to BNT116 and Cemiplimab
- Cohort 6 only: Occurrence of Treatment-Related Delays to Surgery More Than 9 weeks Post the Last Dose of Neo-Adjuvant Treatment
- Sponsor
- BioNTech SE
- Start
- Jun 17, 2022
- Primary completion
- Feb 2030 (estimated)
- Results posted
- No
- Registry record
- NCT05142189 · updated Jul 22, 2026