What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) that target specific molecular features, such as c-Met overexpression, include targeted therapies and immunotherapies. Telisotuzumab Vedotin, an investigational drug, is being compared to docetaxel, a standard chemotherapy agent. Known side effects of docetaxel include neutropenia, fatigue, alopecia, nausea, and peripheral neuropathy. Targeted therapies like Telisotuzumab Vedotin may have side effects such as infusion reactions, liver enzyme abnormalities, and fatigue. Immunotherapies, which are also used in NSCLC, can cause immune-related adverse events like pneumonitis, colitis, and dermatitis.

What prior FDA approvals exist?

Several FDA-approved treatments for Non-Small Cell Lung Cancer (NSCLC) target specific genetic mutations and pathways. For instance, crizotinib is a c-Met inhibitor that has shown activity against certain types of NSCLC. Other targeted therapies include tyrosine kinase inhibitors like gefitinib and erlotinib, which target the EGFR mutation, and ALK inhibitors such as alectinib and ceritinib for ALK-positive NSCLC. These treatments are designed to target specific molecular abnormalities in cancer cells, similar to how Telisotuzumab Vedotin targets c-Met overexpressing cells in NSCLC.

What other types of research exist?

Promising novel alternatives to Telisotuzumab Vedotin for NSCLC patients include selective RET inhibitors like selpercatinib and pralsetinib, which target RET mutations often found in NSCLC. Additionally, MET inhibitors such as cabozantinib and other investigational drugs targeting MET or related pathways may also be considered. These therapies have shown efficacy in clinical trials and offer potential treatment options for NSCLC patients.

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Anti-tumor antibiotic

Telisotuzumab Vedotin vs. Docetaxel for Non-Small Cell Lung Cancer

Phase 3

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A histologically documented non-squamous cell NSCLC that is locally advanced or metastatic.

An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

Must not have

Actionable epidermal growth factor receptor (EGFR) activating mutations.

Participants with adenosquamous histology.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 58.25 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new drug called telisotuzumab vedotin to see if it can treat a specific type of lung cancer better than an existing drug. The study focuses on adults whose lung cancer has not responded to previous treatments. The new drug targets and kills cancer cells by attaching to a specific protein on their surface.

Who is the study for?

Adults with non-squamous NSCLC who've had one prior chemotherapy can join this trial. They must have c-Met overexpressing cancer, confirmed by a specific test, and be suitable for docetaxel therapy. Those with treated brain metastases stable for 2 weeks may qualify. Exclusions include previous docetaxel use, certain lung conditions, unresolved side effects from past treatments, or other recent cancers.

What is being tested?

The study compares Telisotuzumab Vedotin (an experimental drug) to Docetaxel in treating NSCLC that's progressed after treatment. Participants are randomly assigned to receive either drug via IV; Teliso-V every 2 weeks or Docetaxel every 3 weeks until they meet criteria to stop the study drug.

What are the potential side effects?

Potential side effects of Telisotuzumab Vedotin could include fatigue, allergic reactions at infusion time, liver issues and blood cell count changes leading to increased infection risk. For Docetaxel: hair loss, nail changes, nausea and muscle pain might occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is advanced or has spread and is not squamous cell type.

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I can carry out all my daily activities without help.

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My lung cancer shows high levels of c-Met protein.

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My cancer has a known EGFR mutation.

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I have had only one chemotherapy treatment for my advanced cancer.

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My NSCLC has worsened despite treatment.

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My cancer has a genetic change that is not in the EGFR gene.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has a specific change in the EGFR gene.

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My cancer is identified as adenosquamous.

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I have previously been treated with docetaxel.

Select...

I have not received treatments targeting c-Met or containing monomethylauristatin E.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 58.25 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 58.25 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 58.25 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall Survival (OS)

Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)

Secondary study objectives

Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-C30.

Change from Baseline of Physical Functioning as measured by the Physical Functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30).

Duration of Response (DoR), per BICR

+2 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729

59%

Leukopenia

56%

Neutropenia

34%

Hypoaesthesia

31%

Agranulocytosis

22%

Alopecia

22%

Asthenia

19%

Pyrexia

16%

Nail disorder

16%

Oedema peripheral

16%

Diarrhoea

16%

Hypophagia

13%

Alanine aminotransferase increased

13%

Neurotoxicity

13%

Cough

13%

Vomting

Musculoskeletal pain

Headache

Aspartate aminotransferase increased

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Telisotuzumab VedotinExperimental Treatment1 Intervention

Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.

Group II: DocetaxelActive Control1 Intervention

Participants will receive docetaxel every 3 weeks until meeting study drug discontinuation criteria.

0 / 11Eligibility 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

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies and chemotherapies. Targeted therapies, such as Telisotuzumab Vedotin, work by specifically targeting cancer cells that overexpress certain proteins, like c-Met, which is involved in cell growth and survival. By binding to these proteins, these drugs can inhibit tumor growth and induce cancer cell death. Chemotherapies, like docetaxel, work by disrupting cell division, leading to cancer cell death. These mechanisms are crucial for NSCLC patients as they offer more personalized and potentially more effective treatment options, especially for those with specific genetic markers or protein expressions, improving outcomes and reducing side effects compared to traditional chemotherapy.

Emerging therapeutic agents for lung cancer.