In this phase 2, single-arm, multi cohort trial, the safety and efficacy of tepotinib, an oral and once-daily MET inhibitor, will be investigated in patients with advanced or metastatic NSCLC harboring MET alterationsMETex14 skippingWhen METex14 skipping mutations occur in the MET gene, an abnormal MET receptor is produced in which the exon 14 part is mistakenly deleted. As a result, the abnormal MET receptor is not removed from the cell surface, leading to an excess of MET receptors on the surface that continually transmit growth signals, thereby driving cancer.7.
The primary outcome of this trial is:
This trial will also measure:
*For a full list of all outcome measures and inclusion and exclusion criteria, please visit ClinicalTrials.gov NCT02864992.
‡500 mg tepotinib hydrochloride hydrate which is equivalent to 450 mg tepotinib (the free base form).
§Treatment continues until progression of disease, death, withdrawal of consent, or development of unacceptable toxicities.
DC, disease control; DOR, duration of response; HRQoL, health-related quality of life; OR, objective response; OS, overall survival; PFS, progression-free survival.
ClinicalTrials.gov. Tepotinib Phase II in Non-small Cell Lung Cancer (NSCLC) Harboring MET Alterations (VISION). https://clinicaltrials.gov/ct2/show/NCT02864992. Accessed July 2, 2021.
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.