This was a multicenter, open-label, randomized, active-controlled, global phase III study
that enrolled adult participants with locally advanced or metastatic NSCLC with epidermal
growth factor receptor (EGFR) activating mutation, T790M negative,
mesenchymal-to-epithelial transition factor (MET) amplified who had progressed following
EGFR tyrosine kinase inhibitors (TKIs).
The study was conducted in two parts. The initial part was a safety run-in part, which
aimed at assessing the safety and tolerability of capmatinib in combination with
osimertinib and at determining the recommended dosage for the subsequent randomized part.
The randomized part compared the efficacy and safety of capmatinib in combination with
osimertinib to a platinum-based doublet chemotherapy regimen using either cisplatin or
carboplatin, combined with pemetrexed, as second-line treatment.The randomized part was
not initiated.
In the randomized part (if initiated), participants were to receive their assigned
treatment (either capmatinib in combination with osimertinib or platinum-pemetrexed based
doublet chemotherapy) until they experienced any of the following: documented disease
progression according to the Response Evaluation Criteria In Solid Tumors 1.1 (RECIST
1.1) as assessed by the investigator during the run-in part and confirmed by a blinded
independent review committee (BIRC) during the randomized part, withdrawal of consent,
pregnancy, lost to follow-up, or death. Participants who progressed in the
platinum-pemetrexed arm were to be permitted to switch to capmatinib in combination with
osimertinib therapy after BIRC-confirmed, RECIST 1.1-defined progressive disease. If, in
the judgment of the investigator, there was evidence of clinical benefit and the
participant wished to continue, study treatment could be continued beyond the initial
disease progression according to RECIST 1.1 criteria. After treatment discontinuation,
all participants were to be followed for safety evaluations during the safety follow-up
period.
On 11-May-2022, Novartis decided to halt enrollment for this study due to a business
consideration unrelated to any safety concerns. Ongoing patients in the run-in part were
allowed to continue treatment through other post-trial drug supply options, as
applicable. On 27-Dec-2022 the last patient was transitioned off the study, and following
the study protocol this date was declared the Global end of trial date. Randomized part
was not initiated.
