drugset / Trial / NCT05110196
Study of Capmatinib in Indian Patients With MET Exon 14 Skipping Mutation Positive Advanced NSCLC.
NaSingle-groupOpen-labelTreatment
Summary
The Drugs Controller General of India (DCGI) has granted approval for Rahika® (Capmatinib) film-coated tablet 150 and 200 mg for the treatment of adult patients with advanced/metastatic NSCLC whose tumors have a mutation that leads to MET exon 14 skipping mutation with condition to perform a Phase IV clinical trial in Indian patients. As recommended by DCGI, this Phase IV study has been planned to evaluate the safety and efficacy of capmatinib in treatment of adult Indian patients with advanced/metastatic NSCLC whose tumors have a MET exon 14 skipping mutation positive advanced NSCLC in any line of therapy.
Timeline
- Start
- 2022-09-03
- Primary completion
- 2025-08-04
- Completion
- 2025-08-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capmatinib | Small molecule | 150 mg | Oral |
| Subject | Capmatinib | Small molecule | 200 mg | Oral |