Study of Capmatinib in Chinese Adult Patients With Advanced Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation

This was an open-label, multicenter two-cohort phase II study. Chinese adult participants with EGFR wild-type (wt) (EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 L858R substitution mutations), anaplastic lymphoma kinase (ALK) rearrangement negative, advanced (stage IIIB, IIIC or IV) NSCLC disease harboring MET exon 14-skipping (METΔex14) mutations as determined by a Novartis central molecular laboratory were treated in this study. Cohort 1 included treatment naive participants and Cohort 2 participants who failed one or two prior lines of therapy in the advanced stage (stage IIIB, IIIC or IV). Each participant received 400 mg capmatinib tablet twice daily (BID) until either the disease worsened or there were other reasons to discontinue the drug. After treatment discontinuation, participants were followed for safety up to 30 days after the last dose of study drug. In addition to the 30-day safety follow-up, participants who discontinued treatment without documented progressive disease (PD) continued efficacy assessments and patient-reported outcomes (PROs) collection during the post-treatment follow-up until documented progression. After the post-treatment follow-up phase, the participant's survival status was collected as part of the survival follow-up phase. The primary endpoint was the overall response rate (ORR) by cohort as per the blinded independent review committee (BIRC) review. ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) according to RECIST 1.1.