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Monoclonal Antibodies

Telisotuzumab Vedotin for 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
Have locally advanced or metastatic non-small cell lung cancer (NSCLC)
Must have received no more than 2 lines of prior systemic therapy (including no more than 1 line of systemic cytotoxic chemotherapy) in the locally advanced or metastatic setting. Multiple lines of tyrosine kinase inhibitors (TKIs) targeting the same tyrosine kinase (TK) count as 1 line of therapy for the purposes of this eligibility criterion.
Must not have
Have received any live vaccine within 30 days of the first dose of investigational product.
Have a history of other malignancies except those noted within the protocol.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights

Summary

This trial is designed to find what population of Non-Small Cell Lung Cancer patients will respond best to the telisotuzumab vedotin therapy, and then to expand that group to further evaluate efficacy.

Who is the study for?
This trial is for adults with non-squamous Non-Small Cell Lung Cancer (NSCLC) that does not have a certain mutation called EGFR. Participants must have c-Met+ NSCLC, confirmed by specific lab tests, and should have tried no more than two previous systemic therapies. They need to be in good physical condition (ECOG 0-1), and cannot join if they've had other cancers recently, untreated hepatitis B or C, HIV infection, lung diseases like ILD/pneumonitis, or major surgery within the last three weeks.Check my eligibility
What is being tested?
The study is testing Telisotuzumab vedotin on patients who overexpress c-Met and are in their second or third line of cancer treatment. It's done in stages: first to find which NSCLC populations benefit most from the drug (Stage 1 completed), then expanding this group to further test effectiveness (Stage 2), followed by an additional cohort at a different dose level for safety and efficacy evaluation (Stage 3).See study design
What are the potential side effects?
While specific side effects of Telisotuzumab vedotin aren't listed here, similar drugs often cause fatigue, nausea, hair loss (alopecia), blood disorders like anemia or clotting issues; nerve damage leading to numbness or tingling; allergic reactions during infusion; liver problems; and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition is advanced or metastatic non-small cell lung cancer.
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I've had 2 or fewer treatments for my advanced cancer, including only 1 chemotherapy.
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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 not received a live vaccine in the last 30 days.
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I have had cancer before, but it's not one of the types excluded in this study.
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I have had lung inflammation or disease that needed treatment with steroids.
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I don't have serious side effects from cancer treatment, except for hair loss or low blood count.
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My cancer is identified as adenosquamous.
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I have an active hepatitis B infection.
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I do not have an uncontrolled autoimmune disease.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Adverse Events (Alternate dose cohort)
Overall Response Rate (ORR) (Stage 1 and Stage 2)
Secondary outcome measures
Disease Control Rate (DCR) (Stage 1 and Stage 2)
Duration of Response (DoR) (Stage 1 and Stage 2)
Overall Survival (OS) (Stage 1 and Stage 2)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Telisotuzumab vedotinExperimental Treatment1 Intervention
Telisotuzumab vedotin administered via intravenous (IV) infusion every 14 days.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies that inhibit specific molecular pathways involved in tumor growth and progression. Telisotuzumab Vedotin, for example, targets c-Met overexpression, a receptor tyrosine kinase implicated in cell proliferation, survival, and metastasis. By binding to c-Met, Telisotuzumab Vedotin delivers cytotoxic agents directly to cancer cells, minimizing damage to normal cells. Other targeted therapies include inhibitors of the EGFR, ALK, and VEGF pathways, which block signals that promote tumor growth and angiogenesis. These treatments are crucial for NSCLC patients as they offer more personalized and effective options, especially for those with specific genetic mutations or protein overexpressions, leading to improved outcomes and reduced side effects compared to conventional chemotherapy.
Emerging therapeutic agents for lung cancer.

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
983 Previous Clinical Trials
509,091 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
414 Previous Clinical Trials
151,622 Total Patients Enrolled

Media Library

Telisotuzumab Vedotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03539536 — 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: NCT03539536 — Phase 2
Telisotuzumab Vedotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03539536 — Phase 2
~46 spots leftby Oct 2025