Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation

Summary

Participation Requirements

Description

Participants eligible for the study will be randomized in a 2:1 ratio to one of the two treatment arms: capmatinib (investigational therapy) or docetaxel. The randomization will be stratified by prior lines of systemic therapy received for advanced/metastatic disease (one line vs. two lines). For al...

Participants eligible for the study will be randomized in a 2:1 ratio to one of the two treatment arms: capmatinib (investigational therapy) or docetaxel. The randomization will be stratified by prior lines of systemic therapy received for advanced/metastatic disease (one line vs. two lines). For all participants, the respective treatment (either with capmatinib or docetaxel) may be continued beyond initial disease progression as per RECIST 1.1 (as assessed by the investigator and confirmed by BIRC) if, in the judgment of the investigator, there is evidence of clinical benefit, and the participant wishes to continue on the study treatment. After treatment discontinuation, all participants will be followed for safety evaluations during the safety follow-up period, and the participant's status will be collected every 12 weeks as part of the survival follow-up. Participants randomized to docetaxel treatment will be eligible to crossover to receive capmatinib treatment after BIRC-confirmed, RECIST 1.1-defined progressive disease and after meeting the eligibility criteria prior to crossover. The primary objective of this study is to compare the efficacy of capmatinib versus docetaxel by comparing progression-free survival (PFS) by blinded independent review committee (BIRC) according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 between treatment arms.

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