Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)
- Interventional
- Active
- NCT02864992
Contact Information
A Phase II Single-arm Trial to Investigate Tepotinib in Advanced (Locally Advanced or Metastatic) Non-small Cell Lung Cancer With METex14 Skipping Alterations or MET Amplification (VISION)
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.
The study includes 3 cohorts with one primary endpoint (Objective Response Rate). Enrollment
number and completion data is changed by new cohorts.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
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 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 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 or cytologically confirmed advanced (locally advanced or metastatic) NSCLC (all types 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 as determined by the central laboratory or by an assay with appropriate regulatory status
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
- Subjects 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;
- 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
- 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 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 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 or cytologically confirmed advanced (locally advanced or metastatic) NSCLC (all types 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 as determined by the central laboratory or by an assay with appropriate regulatory status
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
- Subjects 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;
- 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