Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)

Inclusion Criteria:

• Signed, written informed consent by participant or legal representative prior to anytrial-specific screening procedure

• Male or female, greater than or equal to (>=) 18 years of age (or have reached theage of majority according to local laws and regulations)

• Measurable disease confirmed by an independent review committee (IRC) in accordancewith RECIST version 1.1

• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1

• A female participant was eligible to participate if she is not pregnant, notbreastfeeding, 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 participant must agree to use and to have their female partners ofchildbearing 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 participant in first-line or pretreated participant with no morethan 2 lines of prior therapy

• Participants with MET alterations, namely METex14 skipping alterations in plasmaand/or tissue as determined by the central laboratory or by an assay withappropriate regulatory status

Exclusion Criteria:

• Participants with characterized Epidermal Growth Factor Receptor (EGFR) activatingmutations that predict sensitivity to anti-EGFR-therapy

• Participants with characterized Anaplastic Lymphoma Kinase (ALK) rearrangements thatpredict 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 InstituteCommon Terminology Criteria for Adverse Events (NCI-CTCAE) from previous anticancertherapy

• Need for transfusion within 14 days prior to the first dose of trial treatment

• Prior chemotherapy, biological therapy, radiation therapy, hormonal therapy foranti-cancer purposes, targeted therapy, or other investigational anticancer therapy (not including palliative radiotherapy at focal sites) within 21 days prior to thefirst 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 thecervix, or other cancer curatively treated and with no evidence of disease for atleast 5 years

• Medical history of difficulty swallowing, malabsorption, or other chronicgastrointestinal disease, or conditions that may hamper compliance and/or absorptionof 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 withhepatitis B or hepatitis C virus

• Substance abuse, active infection, or other acute or chronic medical or psychiatriccondition or laboratory abnormalities that might increase the risk associated withtrial 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 theparticipant from participating in the trial

• Participation in another clinical trial within the past 30 days