Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION) (NCT02864992) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)
United States, Austria, Belgium337 participantsStarted 2016-09-13
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Partici…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1: Cohort A: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Independent Review Committee (IRC)
Timeframe: Time from first treatment up to data cutoff (approximately Month 66)
2
Part 1: Cohort B: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Independent Review Committee (IRC)
Timeframe: Time from first treatment up to data cutoff (approximately Month 66)
3
Part 2: Cohort C: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Independent Review Committee (IRC)
Timeframe: Time from first treatment up to data cutoff (approximately Month 66)
Trial details
NCT IDNCT02864992
SponsorEMD Serono Research & Development Institute, Inc.