Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)

The study included 3 cohorts with one primary endpoint (Objective Response Rate). Enrollment number and completion data is changed by new cohorts.

Inclusion criteria

• Signed, written informed consent by participant or legal representative prior to any trial-specific screening procedure
• Male or female, greater than or equal to (>=) 18 years of age (or have 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 participant was 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 participant 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 participant in first-line or pretreated participant with no more than 2 lines of prior therapy
• Participants 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

• 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