What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include immune checkpoint inhibitors, chemotherapy, and targeted therapies like Telisotuzumab Vedotin. Immune checkpoint inhibitors, such as pembrolizumab and nivolumab, can cause immune-related toxicities including pneumonitis, colitis, hepatitis, and endocrinopathies. Chemotherapy agents like docetaxel and carboplatin are associated with side effects such as nausea, vomiting, myelosuppression, and neuropathy. Targeted therapies, including those aimed at c-Met overexpression, may cause fatigue, gastrointestinal disturbances, and liver enzyme abnormalities. It is important to monitor and manage these side effects to optimize patient outcomes.

What prior FDA approvals exist?

Several FDA-approved drugs target pathways relevant to the treatment of Non-Small Cell Lung Cancer (NSCLC). Crizotinib, an ALK and ROS1 inhibitor, also targets c-Met and has been approved for ALK-positive NSCLC. Capmatinib and Tepotinib are specifically approved for NSCLC with MET exon 14 skipping mutations, directly targeting the c-Met pathway. These drugs highlight the therapeutic potential of targeting c-Met in NSCLC, similar to the investigational drug Telisotuzumab Vedotin, which is being studied for its efficacy in c-Met overexpressing NSCLC.

What other types of research exist?

Promising alternatives to Telisotuzumab Vedotin for NSCLC patients include: 1) Amivantamab, a bispecific antibody targeting EGFR and MET, 2) Mobocertinib, an oral EGFR inhibitor specifically targeting exon 20 insertions, 3) KRAS G12C inhibitors such as Sotorasib and Adagrasib, and 4) RET inhibitors like Selpercatinib and Pralsetinib for RET fusion-positive NSCLC. These agents have shown significant clinical activity and are expected to be important treatment options in 2024.

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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

No Placebo-Only Group

Summary

This trial tests telisotuzumab vedotin, a treatment that targets and kills cancer cells, in NSCLC patients with high c-Met levels. It aims to find the best patient group for this therapy and evaluate its safety and effectiveness. Telisotuzumab vedotin is a specialized treatment targeting c-Met-overexpressing tumor cells, and it has been evaluated in various studies for its safety and efficacy in treating advanced solid tumors, including non-small cell lung cancer.

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.

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).

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Adverse Events (Alternate dose cohort)

Overall Response Rate (ORR) (Stage 1 and Stage 2)

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Telisotuzumab vedotinExperimental Treatment1 Intervention

Telisotuzumab vedotin administered via intravenous (IV) infusion every 14 days.

0 / 10Eligibility criteria met

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.