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Capmatinib (Rahika®) film-coated tablet administered as 400 mg orally twice daily on a continuous dosing schedule for 24 weeks.

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.

Capmatinib 150 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.

Capmatinib 200 mg

Novartis Pharmaceuticals

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.

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.

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).

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Percentage of participants with Adverse Events (AEs), including SAEs, changes in laboratory values, vital signs and ECGs

Percentage of participants with dose modifications, including dose interruptions and dose reductions

Dose intensity is defined as the ratio of total dose received and actual duration

ORR is defined as the proportion of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per RECIST 1.1 and by investigator assessment

OIRR is calculated as the ORR (CR+PR) of lesions in the brain for patients who had measureable disease in the brain at baseline

DOR is defined as the time from first documented response of CR or PR to date of first documented progression or death, whichever comes first, as per RECIST 1.1 criteria and by investigator assessment

TTR is defined as duration of time between the date of first dose of capmatinib and the date of first documented response of either CR or PR as per RECIST 1.1 criteria and by investigator assessment

DCR is defined as the proportion of patients with CR or PR or subjects with stable disease per investigator according to RECIST 1.1 criteria and by investigator assessment

PFS is defined as the time from first dose of capmatinib to the date of the first documented radiological progression as per RECIST 1.1 response criteria or death due to any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Capmatinib in Indian Patients With MET Exon 14 Skipping Mutation Positive Advanced NSCLC.	NCT05110196	Non-Small Cell ...	Capmatinib 150 ... Capmatinib 200 ...	18 Years - 99 Years	Novartis
Study of Capmatinib in Indian Patients With MET Exon 14 Skipping Mutation Positive Advanced NSCLC.	NCT05110196	Non-Small Cell ...	Capmatinib 150 ... Capmatinib 200 ...	18 Years - 99 Years	Novartis

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