VISION

A Phase II, Single-arm Trial to Investigate Tepotinib in Advanced (Stage IIIB/IV) Non-small Cell Lung Cancer With MET Exon 14 (METex14) Skipping Alterations or MET Amplification (VISION)

Objective

This study will look at how effective the study drug (tepotinib) is at stopping the growth and spread of lung cancer. This study will also measure 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

  • 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 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, or MET amplification only in plasma and/or tumor biopsy samplet

NCT ID

NCT02864992