Page last updated: 08/18/2020
In this phase 2 trial the safety and efficacy of tepotinib, an oral and once-daily METMET geneA gene that makes a protein called MET, which is involved in sending signals within cells and in cell growth and survival. Mutated (changed) forms of the MET gene may cause abnormal cells to grow and spread in the body.5 inhibitor, is investigated in combination with osimertinib in patients with MET-amplifiedMET amplificationMET amplification occurs when several copies of the MET gene are created, resulting in increased levels of MET receptor on the cell surface.6 advanced/metastatic NSCLC harboring activating EGFREGFRA protein found on certain types of cells that binds to a substance called epidermal growth factor. The EGFR protein is involved in cell signaling pathways that control cell division and survival.7 mutations with acquired resistance to prior osimertinibTyrosine kinase inhibitorA substance that blocks the action of enzymes called tyrosine kinases. Tyrosine kinases are a part of many cell functions, including cell signaling, growth, and division. These enzymes may be too active or found at high levels in some types of cancer cells, and blocking them may help keep cancer cells from growing. 8 .
The trial will measure:*
*For a full list of all outcome measures, inclusion and exclusion criteria, please visit clinicaltrials.gov, NCT03940703.
* Target enrollment.
**Initially, eligible participants who are detected to be MET amplification positive will be randomly assigned in a ratio of 2:1 to either the combination of tepotinib and osimertinib or tepotinib alone, until 12 are enrolled in the monotherapy arm. After this, all participants will be assigned to the combination. Participants who are randomized to the tepotinib monotherapy will have the opportunity to switch over to the combination of tepotinib plus osimertinib at the time of disease progression. Treatment continues until progression of disease, withdrawal of consent, or development of unacceptable toxicities.
ORR: overall response rate; DLTs: dose-limiting toxicities; PFS: progression-free survival; DOR: duration ofresponse; DC: disease control; OS: overall survival; HRQOL: health-related quality of life; PK: pharmacokinetics
Tepotinib is being investigated in this clinical trial and under clinical investigation in several countries of the world. 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. 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.
Patients should speak with their doctors, who can help determine if a clinical trial might be the right option. Doctors will be able to answer patients' questions about the risk of participating in a trial, and what other options may be available to you.
1 A Study of Tepotinib Plus Osimertinib in Epidermal Growth Factor Receptor (EGFR ) Tyrosine Kinase Inhibitor (TKI) Relapsed Mesenchymal-epithelial Transition Factor (MET) Amplified Non-small Cell Lung Cancer (NSCLC). https://clinicaltrials.gov/ct2/show/NCT03940703. Accessed April 8, 2020.
2 National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/advanced-cancer. Accessed April 5, 2020.
3 National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/799321. Accessed April 5, 2020.
4 National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/combination-therapy. Accessed April 5, 2020.
5 National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/794425. Accessed April 7, 2020.
6 Drilon A et al. J Thorac Oncol. 2017;12:15-26.
7 National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/egfr. Accessed April 7, 2020.
8 National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/tyrosine-kinase-inhibitor. Accessed April 7, 2020.
9 National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/performance-status. Accessed April 7, 2020.
10 National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/grade. Accessed April 7, 2020.