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Monoclonal Antibodies
Telisotuzumab Vedotin for Non-Small Cell Lung Cancer
Phase 2
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have MET amplification in tumor tissue as determined by the Sponsor-designated central laboratory MET FISH Assay or in plasma and/or tissue by a Sponsor-approved assay.
Must have histologically documented non-squamous adenocarcinoma non-small cell lung cancer (NSCLC) that is locally advanced or metastatic.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial will assess a new drug to treat non-small cell lung cancer (NSCLC). 70 participants will receive IV infusions every 2 weeks to see how the treatment affects their disease.
Who is the study for?
Adults with advanced or metastatic non-squamous NSCLC that hasn't been treated yet, specifically those whose tumors have MET amplification. Participants should be in good physical condition (ECOG 0 or 1) and may have had prior cancer treatments if they didn't progress within 6 months after finishing them. They can't join if they've had recent major surgery, unresolved side effects from past cancer therapies, certain other health conditions, a history of lung diseases like pneumonitis, or are eligible for curative treatment.Check my eligibility
What is being tested?
The trial is testing Telisotuzumab Vedotin's effect on disease activity in NSCLC patients with MET amplification. It involves IV infusions every two weeks until criteria for discontinuation are met. The study will monitor the treatment's impact through medical exams, blood tests, side effect checks, and questionnaires at hospital visits.See study design
What are the potential side effects?
While specific side effects of Telisotuzumab Vedotin aren't listed here, similar cancer drugs often cause fatigue, nausea, hair loss (alopecia), low blood counts leading to increased infection risk or bleeding problems; nerve damage might also occur resulting in numbness or tingling.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has MET amplification according to specific tests.
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My lung cancer is advanced or has spread and is not squamous.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR) as Assessed by an Independent Central Review (ICR)
Secondary outcome measures
Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Disease Control Rate (DCR)
Duration of Response (DoR)
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Telisotuzumab VedotinExperimental Treatment1 Intervention
Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
954 Previous Clinical Trials
501,035 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,869 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had only one round of chemotherapy for my advanced lung cancer without it getting worse.I have not had major surgery in the last 3 weeks.My cancer has MET amplification according to specific tests.My cancer has specific genetic changes that make it likely to respond to targeted therapy.I have a history of specific lung conditions or signs of lung inflammation on a CT scan.I have had cancer before, but not the types excluded in the study.I finished cancer treatment over 6 months ago and haven't worsened within 6 months after completing it.I have had treatment for my brain metastases as required.I have side effects from cancer treatment that are not hair loss or anemia.My lung cancer is advanced or has spread and is not squamous.I have been treated with c-Met-targeted antibodies before.I am fully active or restricted in physically strenuous activity but can do light work.You need to have a way for the doctors to measure your disease using specific guidelines called RECIST version 1.1.I have had lung scarring from previous radiation treatment.My non-small cell lung cancer can be treated with the goal of curing it.
Research Study Groups:
This trial has the following groups:- Group 1: Telisotuzumab Vedotin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Telisotuzumab Vedotin been given the thumbs-up by the FDA?
"Based on the available evidence, Telisotuzumab Vedotin was ranked a 2 out of 3 for safety. This is because while there has been some data collected surrounding its security profile, no research exists yet to validate efficacy."
Answered by AI
What is the current cohort size of this experiment?
"Affirmative. Information published on clinicaltrials.gov implies that recruitment is still ongoing for this medical trial, which was first posted November 30th 2022 and underwent a recent edit December 6th 2022. 70 patients must be enrolled at one single site."
Answered by AI
Are there any openings left in this experiment at the moment?
"Affirmative. According to the information provided on clinicaltrials.gov, this clinical trial was initially posted on November 30th 2022 and has been actively looking for 70 patients from 1 medical centre since then."
Answered by AI
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