MedTrace Logo

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

NCT05110196 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-07

No results posted yet for this study

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.

Conditions

  • Non-Small Cell Lung Carcinoma

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-03
Primary Completion
2025-08-04
Completion
2025-08-04

Countries

  • India

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05110196 on ClinicalTrials.gov