Study of Capmatinib in Indian Patients With MET Exon 14 Skipping Mutation Positive Advanced NSCLC.

Summary

The Drugs Controller General of India (DCGI) granted approval for Rahika® (capmatinib) film-coated tablets (150 mg and 200 mg) for the treatment of adult patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbored a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping. As a condition of approval, the DCGI required the conduct of a Phase IV clinical trial in Indian patients. As recommended by the DCGI, this Phase IV study was planned to evaluate the safety and efficacy of capmatinib in adult Indian patients with advanced or metastatic NSCLC with MET exon 14 skipping mutation-positive disease, in any line of therapy.

Timeline

Start

2022-09-03

Primary completion

2025-08-04

Completion

2025-08-04

Drugs

Indications