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This website is an information resource intended only for Healthcare Professionals from U.S. who are interested in information on Clinical Research and EMD Serono clinical trials.

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VISION

Page last updated: 08/26/2020

 

A Phase 2, Single-arm, Multi-cohort Clinical Trial Investigating Tepotinib in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) harboring MET alterations1

ClinicalTrials.gov:

NCT02864992

ADVANCED
METASTATIC Advanced diseaseAdvanced disease means that the cancer has spread to a nearby tissue or lymph node or spread to another part of the body.2

PHASE 2 Phase 2 trialA phase 2 trial is a type of clinical trial which tests the clinical activity in a specific type of cancer or disease. Phase 2 trials may also provide information about the safety of the new treatment and how the treatment affects the body.3

MONOTHERAPY MonotherapyThe use of a single drug to treat a disease or condition.4

NOW ENROLLING

Purpose of this study


 

In this phase 2, single-arm, multi-cohort 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. inhibitor, is investigated in patients with advanced or metastatic NSCLCNon-small cell lung cancerNon-small cell lung cancer is the most common kind of lung cancer. The three main types of non-small cell lung cancer are squamous cell carcinoma, large cell carcinoma, and adenocarcinoma. 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 trial will measure:*

  • Objective response rate by independent review
  • Objective response rate by investigator assessment
  • Duration of response

 

_

Key eligibility criteria*


  • Histologically confirmed advanced/metastatic NSCLC (all histologies including squamous and sarcomatoid) 
  • METex14 skippingMETex14 skippingWhen METex14 skipping alterations 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 subject to decreased targeted protein degredation, leading to sustained MET signaling, driving growth and oncogenesis.7 alteration (plasma and/or tissue biopsy sample)
  • ECOG Performance StatusPerformance StatusA measure of how well a patient is able to perform ordinary tasks and carry out daily activities.8   of 0 or 1 
  • Prior therapy with a checkpoint inhibitor is permitted

Key exclusion criteria*


  • 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.9   activating mutations or ALKALK geneA gene that makes a protein called anaplastic lymphoma kinase (ALK), which is involved in cell growth.10   rearrangements that predict response to anti-EGFR / anti-ALK therapy 
  • Active brain metastases or brain metastasis as the only measurable lesion 
  • Prior treatment with other agents targeting the MET pathway

 

*For a full list of all outcome measures, inclusion and exclusion criteria, please visit clinicaltrials.gov, NCT02864992.

Study design

 

 

* Target enrollment.
** Treatment continues until progression of disease, withdrawal of consent, or development of unacceptable toxicities. It is 500 mg tepotinib hydrochloride hydrate which is equivalent to 450 mg tepotinib (the free base form).

 DOR: duration of response; DC: disease control; PFS: progression-free survival; OS: overall survival; HRQOL: health-related quality of life

  

 

Speak with a doctor to see if a clinical trial is the right option for you.

If you are interested in learning more about clinical trials (or these clinical trials) please visit clincaltrials.gov

 

 

Tepotinib is being investigated in this clinical trial and under clinical investigation in several countries of the worldThis 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.

LOCATIONS

LOCATION CITY STATE POSTAL CODE COUNTRY STATUS

ClinicalTrials.gov. Tepotinib Phase II in Non-small Cell Lung Cancer (NSCLC) Harboring MET Alterations (VISION). https://clinicaltrials.gov/ct2/show/NCT02864992. Accessed April 3, 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/monotherapy. Accessed April 7, 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 National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/non-small-cell-lung-cancer. Accessed April 7, 2020.

Drilon A et al. J Thorac Oncol. 2017;12:15-26.

National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/performance-status. Accessed April 7, 2020.

9 National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/egfr. Accessed April 7, 2020.

10 National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/alk-gene. Accessed April 7, 2020.

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