CTRI/2022/05/042549
Recruiting
Phase 4
A prospective, multicenter, open-label, Phase IV, interventional study to assess the safety and efficacy of Capmatinib in Indian patients with mesenchymal-epithelial transition (MET) exon 14 skipping mutation positive metastatic non-small cell lung cancer (NSCLC)
ovartis Healthcare Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis Healthcare Pvt Ltd
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Signed informed consent must be obtained prior to participation in the study.
- •2\. Adult more than or equal to 18 years old at the time of informed consent.
- •3\.Metastatic NSCLC (Stage IV, according to Version 8 of the AJCC Staging Manual) either treatment naïve or progressed (clinically and/or radiologically) on one or more lines of systemic therapy.
- •4\. Histologically or cytologically confirmed diagnosis of NSCLC with confirmed
- •EGFR wild type and ALK rearrangement negative and who have tested positive MET
- •exon14 skipping mutation Locally available MET report either by reverse
- •transcriptase polymerase chain reaction RTPCR or NGS would be considered in
- •case not available MET testing would be done through NGS based molecular prescreening
- •done as part of the study.
- •5\. Patients must have recovered from all toxicities related to prior systemic therapies to
Exclusion Criteria
- •1\. Prior treatment with any MET inhibitor or hepatocyte growth factor targeting therapy.
- •2\. Presence or history of a malignant disease other than NSCLC that has been
- •diagnosed and/or required therapy within the past 3 years. Exceptions to this
- •exclusion include the following: completely resected basal cell and squamous cell
- •skin cancers and completely resected carcinoma in situ of any type.
- •3\. 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.
- •4\. Patients with known druggable molecular alterations such as ROS1 translocation or
- •BRAF mutation etc which might be a candidate for alternative targeted therapies
Outcomes
Primary Outcomes
Not specified
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