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MS200095-0022 (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

Description

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.

Status

Accepting new patients

Primary Study Objective(s)

The primary of this study is to determine the objective response as assessed by an independent review committee.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Have signed, written informed consent by subject or legal representative prior to any trial-specific screening procedure
  • Are 18 years of age or older
  • Have measurable disease in accordance with RECIST version 1.1
  • Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
  • Are not pregnant, not breastfeeding, does not have childbearing potential or agrees to use effective contraception
  • If male, agrees to use and to have their female partners of childbearing potential use effective contraception
  • Have histologically confirmed advanced (Stage IIIB/IV) Non-small Cell Lung Cancer NSCLC (all histologies including squamous and sarcomatoid)
  • Are treatment naïve patients in first-line or pretreated patients with no more than two lines of prior therapy
  • Have MET alterations, namely METex14 skipping alterations in plasma and/or tissue, or MET amplification only in plasma and/or tumor biopsy sample

Excluding patients who:

  • Have characterized epidermal growth factor receptor (EGFR) activating mutations that predict sensitivity to anti-EGFR-therapy
  • Have characterized anaplastic lymphoma kinase (ALK) rearrangements that predict sensitivity to anti-ALK therapy
  • Ave active brain metastases
  • Have 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 a transfusion within 14 days prior to the first dose of trial treatment
  • Had 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
  • Have brain metastasis as the only measurable lesion
  • Have inadequate hematological, liver, renal, cardiac function
  • Had prior treatment with other agents targeting the Hepatocyte Growth Factor c(HGF/c) -Met pathway
  • Have hypertension uncontrolled by standard therapies (not stabilized to < 150/90 mmHg)
  • Have a 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 five years
  • Have a medical history of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the test product
  • Had major surgery within 28 days prior to the first day of trial treatment
  • Have a known infection with human immunodeficiency virus, or an active infection with hepatitis B or hepatitis C virus
  • Have 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 the investigators
  • Have known hypersensitivity to any of the trial treatment ingredients
  • Have legal incapacity or limited legal capacity
  • Have any reason that, in the opinion of the principal investigator, precludes the subject from participating in the trial
  • Participated in another clinical trial within the past 30 days
     

Accepting new patients

 

Learn more at

clinicaltrials.gov