drugset
drugset / Trial / NCT05488314

A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer

NCT05488314 ↗

Phase 1/2 Active not recruiting 57 enrolled Janssen Research & Development, LLC
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to identify the recommended Phase 2 combination dose (RP2CD\[s\]) of the amivantamab and capmatinib combination therapy in participants with non-small cell lung cancer (NSCLC) in Phase 1 (combination dose selection), and to evaluate the antitumor effect of the amivantamab and capmatinib combination therapy in mesenchymal-epithelial transition (MET) exon 14 skipping mutation and MET amplified NSCLC, when administered at the selected RP2CD(s) in Phase 2 (expansion).

Timeline

Start
2022-12-13
Primary completion
2026-06-09
Completion
2027-04-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Amivantamab Monoclonal antibody 700 mg Intravenous
Subject Amivantamab Monoclonal antibody 1050 mg Intravenous
Subject Capmatinib Small molecule 400 mg Oral

Indications

non-small cell lung carcinoma