In this phase 2 trial, the safety and efficacy of tepotinib, an oral and once-daily MET inhibitor, will be investigated when it is administered in combination with osimertinib in patients with MET-amplified, advanced or metastatic NSCLC harboring activating EGFR mutations with acquired resistance to prior osimertinib.
The primary outcomes of this trial are:
This trial will also measure:
*For a full list of all outcome measures and inclusion and exclusion criteria, please visit ClinicalTrials.gov, NCT03940703.
†Patients must have had a radiologically confirmed response or stable disease (for a least 6 months) to treatment with first-line osimertininb, followed by radiologically documented disease progression.
§500 mg tepotinib hydrochloride hydrate which is equivalent to 450 mg tepotinib (the free base form).
Initially, eligible patients who are detected to be positive for MET amplification will be randomly assigned in a ratio of 2:1 to either the combination of tepotinib osimertinib or tepotinib alone until 12 patients with MET amplification centrally confirmed by FISH ( TBx ) are enrolled in the monotherapy arm. After this, all patients will be assigned to the combination. Patients who are randomized to tepotinib monotherapy will have the opportunity to switch over to the combination at the time of disease progression.
Treatment continues until progression of disease, death, withdrawal of consent, or development of unacceptable toxicities.
DC, disease control; DLT, dose-limiting toxicity; DOR, duration of response; HRQoL, health-related quality of life; OR, objective response; OS, overall survival; PFS, progression-free survival; PK, pharmacokinetics.
Tepotinib is being investigated in this clinical trial and is under clinical investigation in several countries. This page describes one of the clinical trials for tepotinib, and it includes information about how the safety and efficacy of tepotinib will be measured and evaluated. The safety and efficacy of tepotinib have to be investigated following the respective local regulations and laws. There is no guarantee that tepotinib will be approved in the sought-after indication by the competent health authority in your country.