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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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INSIGHT 2

Page last updated: 08/18/2020

 

A Phase 2 Clinical Trial to Investigate Tepotinib Combined with Osimertinib in Patients with Osimertinib-Resistant, MET Amplified Non-Small Cell Lung Cancer (NSCLC)1

ClinicalTrials.gov:

NCT03940703

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 body2 

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 body3

COMBINATION
THERAPY Combination therapyA therapy where a patient is treated with more than one type of cancer treatment. The different cancer treatments usually work in different ways to try and improve the effect of the treatment4

NOW ENROLLING

Purpose of this study


 

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. 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. 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:*

  • Objective response rate (by independent review)
  • Dose-limiting toxcities (safety run-in only)

  

Key eligibility criteria*


  • Histologically confirmed locally advanced or metastatic NSCLC with documented, activating
    EGFR
    EGFRA 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    mutation
  • 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. amplification
  • Acquired resistance on prior first-line osimertinib therapy
  • ECOG Performance StatusPerformance StatusA measure of how well a patient is able to perform ordinary tasks and carry out daily activities.9   of 0 or 1 

 

Key exclusion criteria*


  • Patients with symptomatic brain metastases who are neurologically unstable
  • Inadequate hematological, liver, renal, or cardiac function, or hypertension uncontrolled by standard therapies
  • Any unresolved GradeGradeIn cancer, a description of a tumor based on how abnormal the cancer cells and tissue look under a microscope and how quickly the cancer cells are likely to grow and spread. Low-grade cancer cells look more like normal cells and tend to grow and spread more slowly than high-grade cancer cells.10   2 or higher toxicity from previous therapies

 

 

*For a full list of all outcome measures, inclusion and exclusion criteria, please visit  clinicaltrials.gov, NCT03940703.

Study design

 

 

* 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

  

 

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

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.

National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/advanced-cancer. Accessed April 5, 2020.

National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/799321. Accessed April 5, 2020.

National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/combination-therapy. Accessed April 5, 2020.

National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/794425. Accessed April 7, 2020.

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.

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