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Monoclonal Antibodies

Telisotuzumab Vedotin for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
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.
Must not have
Have a history of other malignancies except those noted in the protocol.
Alterations in EGFR, ALK, ROS1, or BRAF that predict sensitivity to available targeted therapy. Participants with other alterations that are candidates for available targeted therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had cancer before, but not the types excluded in the study.
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My cancer has specific genetic changes that make it likely to respond to targeted therapy.
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I have a history of specific lung conditions or signs of lung inflammation on a CT scan.
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I have side effects from cancer treatment that are not hair loss or anemia.
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I have been treated with c-Met-targeted antibodies before.
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My non-small cell lung cancer can be treated with the goal of curing it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective response rate (ORR) as Assessed by an Independent Central Review (ICR)
Secondary study objectives
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 more

Trial 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
1,004 Previous Clinical Trials
513,769 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
430 Previous Clinical Trials
156,089 Total Patients Enrolled

Media Library

Telisotuzumab Vedotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05513703 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Telisotuzumab Vedotin
Non-Small Cell Lung Cancer Clinical Trial 2023: Telisotuzumab Vedotin Highlights & Side Effects. Trial Name: NCT05513703 — Phase 2
Telisotuzumab Vedotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05513703 — Phase 2
~2 spots leftby Mar 2025
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