NCT05110196

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

A Prospective, Multicenter, Open-label, Phase IV, Interventional Study to Assess the Safety and Efficacy of Capmatinib in Indian Patients With Mesenchymalepithelial Transition (MET) Exon 14 Skipping Mutation Positive Advanced Nonsmall Cell Lung Cancer (NSCLC).

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase IV, prospective, multicenter, open-label, interventional study. The study will include approximately 50 patients. The study will include molecular prescreening (28 days for patients who do not have documented MET exon 14 skipping mutation positive results), screening period (28 days), treatment period of 24 weeks, end of treatment (EOT) visit, and follow-up period of 30 days post last dose of study treatment. During the treatment period, study treatment will be administered as capmatinib 400 mg orally as twice daily (BID) on a continuous dosing schedule for 24 weeks. The treatment with capmatinib will be started only when the previous anti-cancer treatment was stopped within 4 weeks or ≥5 x half-life (whichever is longer) in subject who were on prior line/s of treatment. The treatment period begins on Day 1 of Cycle 1. Each treatment cycle will be of 21 days. Cycle 2 will start on Day 22 of the study and will be considered as Cycle 2 Day 22 (C2D22) and so on if there is no temporary discontinuation Patients may be discontinued from treatment earlier due to unacceptable toxicity, disease progression, withdrawal of consent, or at the discretion of the investigator or the patient. These patients will have end of study (EOS) assessment 30 days after the administration of last dose of the study treatment. Every effort will be made by Novartis to continue provision of study treatment capmatinib via post trial access (PTA) to the patients who are ongoing on treatment at the end of the planned duration of study and deriving clinical benefit. Patients transitioning to PTA will also have to compete the EOS Visit assessment after the last dose administration of capmatinib for the current study.

Conditions

• Non-Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	Capmatinib 150 mg	Capmatinib film-coated tablet 150 mg administered BID with or without food for 24 weeks. It should be swallowed whole and should not be broken, chewed, or crushed.
DRUG	Capmatinib 200 mg	Capmatinib film-coated tablet 200 mg administered BID with or without food for 24 weeks. It should be swallowed whole and should not be broken, chewed, or crushed.

Timeline

• Start date: 2022-09-03
• Primary completion: 2025-08-04
• Completion: 2025-08-04
• First posted: 2021-11-05
• Last updated: 2026-04-07

Locations

15 sites across 1 country: India