Study of Capmatinib in Indian Patients With MET Exon 14 Skipping Mutation Positive Advanced NSCLC. (NCT05110196) | Clinical Trial Compass
CompletedPhase 4
Study of Capmatinib in Indian Patients With MET Exon 14 Skipping Mutation Positive Advanced NSCLC.
India50 participantsStarted 2022-09-03
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. 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:
✓
What they're measuring
1
Percentage of participants with Adverse Events (AEs)
Timeframe: From first dose of study treatment administration until end of study, assessed up to 7 months
2
Percentage of participants with dose modifications
Timeframe: From first dose of study treatment administration until end of treatment, assessed up to 6 months
3
Dose intensity
Timeframe: From first dose of study treatment administration until end of treatment, assessed up to 6 months
. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.
Exclusion criteria
✕. Prior treatment with any MET inhibitor or hepatocyte growth factor -targeting therapy.
✕. 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
✕. 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.