Last updated on July 2019

Tepotinib Phase II in Non-small Cell Lung Cancer (NSCLC) Harboring MET Alterations

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Advanced (Stage IIIB/IV) Non-small Cell Lung Cancer With MET Exon 14 (METex14) Skipping Alterations or MET Amplification | Advanced (Stage IIIB/IV) Non-small Cell Lung Cancer With MET Exon 14 (METex14) Skipping Alterations
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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 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 confirmed advanced (Stage IIIB/IV) Non-small Cell Lung Cancer NSCLC (all histologies including squamous and sarcomatoid)
  • Treatment nave 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, or MET amplification only in plasma and/or tumor biopsy samplet

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
  • Active brain metastases
  • 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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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