Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Non-small Cell Lung Cancer

This was a two-part prospectively designed, multicenter, open-label, randomized phase II

study.

Part 1: Run-in. Prior to the randomized part of the study, a run-in to assess the safety

and tolerability as well as preliminary efficacy of the capmatinib and spartalizumab

combination was conducted. Participants were treated with capmatinib 400 mg twice daily

(BID) and spartalizumab 400 mg intravenously (i.v.) once every 28 days. A review was

planned to take place after all participants had at least 24 weeks of follow-up. The

decision to expand the study to the randomized part was to be based on the safety,

tolerability, and preliminary efficacy of the capmatinib and spartalizumab combination.

Part 2: Randomized. Subjects were planned to be randomized to one of the following arms

in a 2:1 ratio: 1) combination of capmatinib 400 mg BID and spartalizumab 400 mg i.v.

once every 28 days; 2) docetaxel 75 mg/m2 i.v. following local guidelines as per standard

of care and product labels. Based on the results obtained in the run-in part of the

study, the randomized part was not opened.

For the run-in part of the study, the treatment period began on Cycle 1 Day 1 and

continued in 28-day cycles until disease progression, unacceptable toxicity, withdrawal

of informed consent, pregnancy, lost to follow-up, or death irrespective of start of new

anti-neoplastic therapy. After treatment discontinuation, all subjects were followed for

safety evaluations during the safety follow-up period, and the subject's status was

collected every 8 weeks as part of the survival follow-up