Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)

Exclusion Criteria

• •Participants with characterized Epidermal Growth Factor Receptor (EGFR) activating mutations that predict sensitivity to anti-EGFR-therapy
• •Participants with characterized Anaplastic Lymphoma Kinase (ALK) rearrangements that predict sensitivity to anti-ALK therapy
• •Participants with symptomatic brain metastases who are neurologically unstable
• •Any unresolved toxicity Grade 2 or more according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) from previous anticancer therapy
• •Need for transfusion within 14 days prior to the first dose of trial treatment
• •Prior chemotherapy, biological therapy, radiation therapy, hormonal therapy for anti-cancer purposes, targeted therapy, or other investigational anticancer therapy (not including palliative radiotherapy at focal sites) within 21 days prior to the first dose of trial treatment;
• •Participants who have brain metastasis as the only measurable lesion
• •Inadequate hematological, liver, renal, cardiac function
• •Prior treatment with other agents targeting the Hepatocyte Growth Factor c(HGF/c) -Met pathway
• •Hypertension uncontrolled by standard therapies (not stabilized to \< 150/90 mmHg)
• •Past or current history of neoplasm other than Non-small Cell Lung Cancer (NSCLC), except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least 5 years
• •Medical history of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the test product
• •Major surgery within 28 days prior to Day 1 of trial treatment
• •Known infection with human immunodeficiency virus, or an active infection with hepatitis B or hepatitis C virus
• •Substance abuse, active infection, or other acute or chronic medical or psychiatric condition or laboratory abnormalities that might increase the risk associated with trial participation at the discretion of Investigators
• •Known hypersensitivity to any of the trial treatment ingredients
• •Legal incapacity or limited legal capacity
• •Any other reason that, in the opinion of the Principal Investigator, precludes the participant from participating in the trial
• •Participation in another clinical trial within the past 30 days