Study on the Safety and Effects of Telisotuzumab Vedotin for Previously Treated Non-Squamous Non-Small Cell Lung Cancer

Sponsor: AbbVie

Sponsor score: 60

ClinicalTrials ID:NCT06568939

This clinical trial is testing the safety and effects of an investigational drug, telisotuzumab vedotin, in adults with non-squamous non-small cell lung cancer (NSCLC) that has been previously treated. The study will monitor how the drug moves through the body and its impact on the cancer.

Patient Parameters

Program Overview

This study is focused on understanding how safe and effective telisotuzumab vedotin is for treating non-small cell lung cancer (NSCLC) in adults. NSCLC is a type of lung cancer where cancer cells form in the lung tissues. The study will involve about 100 participants worldwide, who will receive the drug through an IV infusion. Participants will be divided into two groups, each receiving a different dose of the drug. The study will last for about three years, during which participants will have regular hospital or clinic visits for medical assessments, blood tests, and to check for any side effects.

Eligibility Criteria

Inclusion Criteria

  • Expected to live at least 12 more weeks.
  • Have non-small cell lung cancer (NSCLC) with high levels of a protein called c-Met.
  • Cancer must be advanced or have spread to other parts of the body.
  • Must know the status of a specific gene mutation called EGFR.
  • Other gene changes that can be targeted by treatment are allowed.
  • Must have cancer that can be measured by standard criteria.
  • Must be in good general health, able to carry out normal activities or light work.
  • Have had no more than one previous chemotherapy treatment for advanced cancer.
  • Cancer must have worsened after at least one previous treatment for advanced NSCLC.

Exclusion Criteria

  • Have a type of lung cancer with certain specific features, like adenosquamous or neuroendocrine types.
  • Have specific EGFR gene mutations that can be targeted by treatment.
  • Have previously received treatments targeting c-Met or similar drugs.
  • Have had previous treatment with a drug called docetaxel.
  • Have cancer that has spread to the brain or spinal cord unless it has been treated.
  • Have a history of other cancers, unless specified in the study.
  • Have certain lung conditions or active lung inflammation.
  • Have unresolved significant side effects from previous cancer treatments, except for hair loss or anemia.
  • Have had major surgery within the last 21 days.
  • Have significant health conditions, including liver disease or alcohol abuse.
  • Have significant swelling, fluid buildup, or nerve problems.
  • Have an active, uncontrolled infection.
  • Have an active eye disorder affecting the cornea.

Locations

FACILITYZIPCITYSTATE
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 27089932256JacksonvilleFlorida
Comprehensive Hematology Oncology /ID# 27042233701-4732Saint PetersburgFlorida
Astera Cancer Care /ID# 27235908816-4096East BrunswickNew Jersey
Clinical Research Alliance - Westbury /ID# 27045511590WestburyNew York
Guthrie Robert Packer Hospital /ID# 27031618840SayrePennsylvania
Northwest Medical Specialties Tacoma /ID# 27053498405TacomaWashington

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