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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. 

By clicking “I am a healthcare professional” you are declaring and confirming that you are a Healthcare Professional inside the U.S. and have read and understood this disclaimer.

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VISION: Advanced/Metastatic NSCLC With MET Alterations

A phase 2 clinical study of tepotinib in patients with advanced (locally advanced or metastatic) non-small cell lung cancer (NSCLC) with changes in the MET gene

ClinicalTrials.gov:

NCT02864992

tepotinib nsclc vision clinical trial advanced metastatic icon

ADVANCED
METASTATIC

phase 2 tepotinib nsclc vision clinical trial icon

PHASE 2

tepotinib nsclc vision clinical trial monotherapy icon

MONOTHERAPY

ACTIVE, NOT RECRUITING

Purpose of this study


 

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:

  • Objective response (by independent review)

This trial will also measure:

  • Objective response (by investigator)
  • Duration of response, disease control, progression-free survival (by independent review and by investigator)
  • Overall survival
  • Safety
  • Pharmacokinetics 
  • Health-related quality of life

 

Contact us


 

US Medical Information: 888-275-7376 - eMediUSA@emdserono.com

Global Communication Center: +49 6151 72 5200 - service@emdgroup.com

Singapore Medical Information: +65 6890 6638 - medinfo_singapore@merckgroup.com

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Key inclusion criteria for VISION*


  • Locally advanced or metastatic NSCLC confirmed by histology or cytology (all histologies, including squamous and sarcomatoid) 
  • MET alterations in plasma and/or tissue biopsy (central testing) or by an assay with appropriate regulatory status
  • ECOG performance status of 0 or 1 
  • Age ≥18 years

Key exclusion criteria for VISION*


  • EGFR activating mutations or ALK rearrangements that predict response to anti-EGFR/anti-ALK therapy 
  • Patients with active brain metastases or brain metastases as the only measurable lesion
  • Prior treatment with other agents targeting the MET pathway

 

VISION Study Design

 

tepotinib mcrc vision targeting met clinical trial study design infographic

 

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

†Actual enrollment.

‡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.

Reference:

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.

  

Please email this page. 

 

 

Tepotinib is being investigated in this clinical trial and is under clinical investigation in several countriesThis 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.

VISION LOCATIONS

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