Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)
Condition: Advanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 (METex14) Skipping Alterations or MET Amplification; Lung Adenocarcinoma Stage IIIB/IV
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Adenocarcinoma of Lung
Intervention: Tepotinib
Intervention description: Subjects will receive 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Intervention MeSH terms: Tepotinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 337.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: lung; neoplasm; cancer; tumor; adenocarcinoma; MET exon 14; METex14; pulmonary; stage III; stage IV; c-Met; cMET; NSCLC; advanced non-small cell lung cancer; MET amplification; non-small cell lung cancer

Summary:

      This study looked at how effective the study drug (tepotinib) was at stopping the growth and
      spread of lung cancer. This study also measures a number of other things including safety of
      the study drug and the side effects, how body processes the study drug, or how the study drug
      affects your quality of life. The study also has an optional pharmacogenetic research part.
      Pharmacogenetic research is an important way to try to understand the role of genetics in
      human disease and how genes impact the effectiveness of drugs, because differences in genes
      can change the way a person responds to a particular drug.
    

Eligibility criteria:

        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