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

NCT05110196 | Completed Phase 4

• 1 other identifier: CINC280AIN01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 15

Brief 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

Keywords

Carcinoma, Non-Small Cell Lung; Non-Small Cell Lung Cancer; Non small Cell Lung Cancer; Lung Neoplasms; Bronchial neoplasms; Mesenchymal-Epithelial Transition exon 14 Skipping Mutation Positive Advanced Non-Small Cell Lung Cancer; NSCLC; MET; Lung Cancer; Carcinoma

Outcome Measures

Primary Outcomes (3)

• Percentage of participants with Adverse Events (AEs)

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

  From first dose of study treatment administration until end of study, assessed up to 7 months

• Percentage of participants with dose modifications

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

  From first dose of study treatment administration until end of treatment, assessed up to 6 months

• Dose intensity

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

  From first dose of study treatment administration until end of treatment, assessed up to 6 months

Secondary Outcomes (6)

• Overall Response Rate (ORR)

  From first dose of study treatment up to a maximum duration of 7 months

• Overall Intracranial Response Rate (OIRR)

  From first dose of study treatment up to a maximum duration of 7 months

• Duration of Response (DOR

  From first documented response to first documented progression or death, assessed up to 7 months

• Time To response (TTR)

  From first dose of study treatment up to first documented response, assessed up to 7 months

• Disease Control Rate (DCR)

  From first dose of study treatment up to a maximum duration of 7 months

Study Arms (1)

Capmatinib

EXPERIMENTAL

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

Drug: Capmatinib 150 mg; Drug: Capmatinib 200 mg

Interventions

Capmatinib 150 mg DRUG

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.

Also known as: Rahika® 150mg

Capmatinib

Capmatinib 200 mg DRUG

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.

Also known as: Rahika® 200 mg

Capmatinib

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form (ICF) must be obtained prior to participation in the study.
• Adult ≥18 years old at the time of informed consent.
• Stage IIIB/IIIC (not amenable to surgery, radiation or multi-modality therapy) or Stage IV NSCLC (according to Version 8 of the AJCC Staging Manual) either treatment naive or progressed on 1 or more lines of therapy at the time of study entry.
• Histologically or cytologically confirmed diagnosis of NSCLC with confirmed EGFR wild-type and ALK rearrangement negative and who have tested positive test for MET exon14 skipping mutation (Locally available MET report either by RT-PCR or Next Generation Sequencing \[NGS\] would be considered, in case not available MET testing would be done through NGS based platform during molecular pre-screening done as part of the study).
• Patients must have recovered from all toxicities related to prior systemic therapies to grade ≤1 (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0).
• At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
• Patients must have adequate organ function including the following laboratory values at the screening visit:
• Absolute neutrophil count ≥1.5 x 109/L without growth factor support
• Platelets ≥100 x 109/L
• Hemoglobin ≥9 g/dL
• Calculated creatinine clearance (using Cockcroft-Gault formula) ≥45 mL/min
• Total bilirubin ≤1.5 upper limit of normal (ULN) (except in patients with Gilbert's syndrome, who may be included if total bilirubin is ≤3.0 x ULN and direct bilirubin is ≤1.5 x ULN))
• Aspartate transaminase (AST) ≤3 x ULN, except for patients with liver metastasis, who may only be included if AST ≤5 x ULN
• Alanine transaminase (ALT) ≤3 x ULN, except for patients with liver metastasis, who may only be included if ALT ≤5 x ULN
• Alkaline phosphatase ≤5.0 x ULN

You may not qualify if:

• Prior treatment with any MET inhibitor or hepatocyte growth factor -targeting therapy.
• Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
• Patients with known druggable molecular alterations (such as ROS1 translocation or BRAF mutation, etc.) which might be a candidate for alternative targeted therapies as applicable per local regulations and treatment guidelines.
• Presence or history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention).
• Patients with clinically significant heart diseases like unstable angina/acute myocardial infarction within 6 months prior to screening, NYHA class III-IV congestive cardiac failure, uncontrolled hypertension, arrhythmias or QTcF≥470 ms on the screening electrocardiogram (ECG)
• Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeks prior (2 weeks for resection of brain metastases) to starting capmatinib or who have not recovered from side effects of such procedure. Video-assisted thoracic surgery and mediastinoscopy will not be counted as major surgery and patients can be enrolled in the program ≥1 week after the procedure
• Thoracic radiotherapy to lung fields ≤4 weeks prior to starting capmatinib or patients who have not recovered from radiotherapy-related toxicities.
• For all other anatomic sites (including radiotherapy to thoracic vertebrae and ribs), radiotherapy ≤2 weeks prior to starting capmatinib or patients who have not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions ≤2 weeks prior to starting capmatinib is allowed.
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of capmatinib or patients who are unable to swallow oral tablets.
• Patients receiving treatment with strong inducers of CYP3A that cannot be discontinued at least 1 week prior to the start of treatment with capmatinib and for the duration of the study
• Unable or unwilling to swallow tablets as per dosing schedule
• Patients with known hypersensitivity to capmatinib and any of the excipients of capmatinib.
• Patients with any other severe, acute or chronic medical or psychotic conditions or significant abnormal physical findings that in the opinion of the investigator may increase the risk associated with study participation or that may interfere with the interpretation of study results.
• Previous (within 28 days) or concomitant participation in another clinical study with investigational medicinal product(s).
• Pregnant or nursing (lactating) women.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (15)

Novartis Investigative Site

Gujarat, Gujarat, 380016, India

Location

Novartis Investigative Site

Mangalore, Karnataka, 575002, India

Location

Novartis Investigative Site

Thalassery, Kerala, 670103, India

Location

Novartis Investigative Site

Trivandrum, Kerala, 695 011, India

Location

Novartis Investigative Site

Bhopal, Madhya Pradesh, 462001, India

Location

Novartis Investigative Site

Mumbai, Maharashtra, 400 012, India

Location

Novartis Investigative Site

Mumbai, Maharashtra, 400056, India

Location

Novartis Investigative Site

Nagpur, Maharashtra, 441108, India

Location

Novartis Investigative Site

Pune, Maharashtra, 411040, India

Location

Novartis Investigative Site

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Novartis Investigative Site

Bhubaneshwar, Odisha, 751007, India

Location

Novartis Investigative Site

Hyderabad, Telangana, 500004, India

Location

Novartis Investigative Site

Varanasi, Uttar Pradesh, 221005, India

Location

Novartis Investigative Site

Kolkata, West Bengal, 700 020, India

Location

Novartis Investigative Site

Puducherry, 605006, India

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Bronchial Neoplasms; Carcinoma

Interventions

capmatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Bronchial Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 5, 2021
• Study Start: September 3, 2022
• Primary Completion: August 4, 2025
• Study Completion: August 4, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

IN (15)