Study of efficacy of capmatinib in comparison with standard of care docetaxel as a second or third line therapy in participants with non-small cell lung cancers harboring MET exon 14 skipping mutation.
- Conditions
- Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
- Registration Number
- CTRI/2020/09/027575
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Stage IIIB or IIIC (not amenable to surgery, radiation or multi modality therapy) or IV NSCLC (according to Version 8 of the American Joint Committee on Cancer (AJCC) Staging Manual) at the time of study entry.
2. 3.Mandatory provision of a formalin-fixed, paraffin embedded tumor tissue sample (archival tumor block or slides, or a newly obtained tumor sample)
3. 4.Progressed on one or two prior lines of systemic therapy for advanced/metastatic disease (stage IIIB/IIIC [not candidates for surgery, radiation or multi modality therapy] or IV NSCLC) and must be candidates for single agent chemotherapy (docetaxel).
4. At least one measurable lesion as defined by RECIST 1.1
5. Adequate organ function
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
1. Prior treatment with any MET inhibitor or HGF-targeting therapy.
2. Presence or history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (affecting activities of daily living or requiring therapeutic intervention).
3. Substance abuse, active infection or other severe, acute, or chronic medical or psychotic conditions or laboratory abnormalities that in the opinion of the investigator may increase the risk associated with study participation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the efficacy of capmatinib versus docetaxelTimepoint: Progression-free survival (PFS) by BIRC as per <br/ ><br>RECIST 1.1
- Secondary Outcome Measures
Name Time Method To assess the antitumor activity of capmatinib <br/ ><br>versus docetaxelTimepoint: 1. All calculated per RECIST 1.1, both by BIRC and investigator: <br/ ><br>a. Overall response rate (ORR) <br/ ><br>b. Duration of response (DOR) <br/ ><br>c. Time to response (TTR) <br/ ><br>d. Disease control rate (DCR) <br/ ><br>All calculated per RECIST 1.1, by investigator: <br/ ><br>a. PFS;To characterize the pharmacokinetics of <br/ ><br>capmatinib in this study populationTimepoint: Plasma concentrations and plasma PK <br/ ><br>parameters based on population PK model as <br/ ><br>appropriate.;To evaluate overall survival (OS) in participants <br/ ><br>treated with capmatinib versus docetaxelTimepoint: Overall survival;To evaluate the safety profile of capmatinib versus docetaxelTimepoint: Incidence of adverse events and serious <br/ ><br>adverse events, change in vital signs, laboratory <br/ ><br>results and ECG