Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)

Inclusion Criteria:

Signed, written informed consent by subject or legal representative prior to any trial-specific screening procedure
Male or female, greater than or equal to (>=) 18 years of age (or having reached the age of majority according to local laws and regulations
Measurable disease confirmed by an independent review committee (IRC) in accordance with RECIST version 1.1
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Not a woman of childbearing potential OR
A woman of childbearing potential who agrees to use a highly effective contraception
A male subject must agree to use and to have their female partners of childbearing potential to use a highly effective contraception
Histologically or cytologically confirmed advanced (locally advanced or metastatic) NSCLC (all types including squamous and sarcomatoid)
Treatment naïve patients in first-line or pretreated patients with no more than 2 lines of prior therapy
Subjects with MET alterations, namely METex14 skipping alterations in plasma and/or tissue as determined by the central laboratory or by an assay with appropriate regulatory status

Exclusion Criteria:

Subjects with characterized Epidermal Growth Factor Receptor (EGFR) activating mutations that predict sensitivity to anti-EGFR-therapy
Subjects with characterized Anaplastic Lymphoma Kinase (ALK) rearrangements that predict sensitivity to anti-ALK therapy
Subjects 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;
Subjects 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 subject from participating in the trial
Participation in another clinical trial within the past 30 days