ACTIVE, NOT RECRUITING
In this phase 2 trial, the safety and efficacy of tepotinib, an oral and once-daily MET inhibitor, was investigated when it was administered in combination with osimertinib in patients with MET-amplified, advanced or metastatic NSCLC harboring activating EGFR mutations with acquired resistance to prior osimertinib.1-3
The primary outcomes of this trial were:
This trial also measured:
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*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.
‡Actual enrollment.
§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.