A double-blind, placebo controlled, randomized, phase II study evaluating the efficacy
and safety of capmatinib (INC280) and spartalizumab (PDR001) combination therapy versus
capmatinib and placebo as first line treatment for locally advanced or metastatic
non-small cell lung cancer (NSCLC) patients with MET exon 14 skipping (METΔex14)
mutations
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04323436.
The purpose of this study was to evaluate the efficacy and safety of capmatinib in
combination with spartalizumab in treatment naive patients with EGFR wild-type, ALK
rearrangement negative advanced NSCLC, harboring METΔex14 mutations.
A run-in part (Part 1) was conducted to determine the anti-tumor activity and safety of
capmatinib in combination with spartalizumab. Upon review of safety data and confirmation
of anti-tumor activity in Part 1, the randomized part (Part 2) was planned to be
initiated to compare the efficacy and safety of capmatinib plus spartalizumab to
capmatinib plus placebo.
Combined treatment of METΔex14 mutated NSCLC with capmatinib and spartalizumab was
expected to result in improved efficacy compared to each single agent due to direct
targeting of an oncogenic driver (MET) as well as more efficient stimulation of an
anti-tumor immune response than with PD-1 blockade alone.
The study enrollment was halted on 28-Jul-2021 per sponsor's decision. The enrollment
halt decision was based on lack of tolerability observed in capmatinib and spartalizumab
combination treatment in the run-in part (Part 1) of the trial.
Following the study enrollment halt during Part 1 (Run in Part), Part 2 was not
initiated.
Immediately following the enrollment halt:
- All ongoing subjects were discontinued from spartalizumab treatment and continue to
receive single agent capmatinib
- Enrolled subjects who had not started study treatment were to receive capmatinib
single agent treatment from the start
Lead OrganizationNovartis Pharmaceuticals Corporation
