Study Comparing IV Telisotuzumab Vedotin and IV Docetaxel in Adults with Previously Treated Non-Squamous Non-Small Cell Lung Cancer
Sponsor: AbbVie
ClinicalTrials ID:NCT04928846
This clinical trial is testing whether the investigational drug telisotuzumab vedotin is more effective and safer than the standard drug docetaxel for adults with non-squamous non-small cell lung cancer (NSCLC) who have already received treatment.
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Program Overview
This study aims to find out if telisotuzumab vedotin works better than docetaxel in treating non-small cell lung cancer (NSCLC) in adults who have already been treated. The study will also check how safe telisotuzumab vedotin is. Participants will be randomly assigned to receive either telisotuzumab vedotin or docetaxel through an IV. About 698 adults with a specific type of NSCLC will take part in this study at around 300 locations worldwide. Participants will receive their assigned treatment every 2 or 3 weeks until they meet the criteria to stop the study drug. The study involves regular hospital or clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires.
Eligibility Criteria
Inclusion Criteria
- Expected to live at least 12 more weeks.
- Have a specific type of non-small cell lung cancer (NSCLC) with high levels of a protein called c-Met, confirmed by a special lab test.
- Provide a tumor sample for testing c-Met levels.
- Have non-squamous cell NSCLC that is advanced or has spread.
- Know the status of a specific gene mutation called EGFR.
- Have changes in genes other than EGFR that can be targeted by treatments.
- Have measurable cancer according to standard criteria.
- Be in good general health with a performance status score of 0 or 1.
- Have received no more than one previous chemotherapy treatment for advanced cancer.
- Have cancer that has progressed after at least one previous treatment for advanced NSCLC.
- Be suitable for docetaxel treatment as determined by the doctor.
- If cancer has spread to the brain, it must be treated and stable, with no symptoms and minimal steroid use.
Exclusion Criteria
- Have new or untreated cancer spread to the brain.
- Have cancer spread to the lining of the brain or spinal cord.
- Have a type of lung cancer called adenosquamous or neuroendocrine, or have sarcomatoid features.
- Have specific EGFR gene mutations.
- Have received previous treatments targeting c-Met or similar drugs.
- Have had docetaxel treatment before.
- Have a history of other cancers unless treated and inactive for at least 2 years.
- Have certain lung conditions like idiopathic pulmonary fibrosis or active pneumonitis.
- Have unresolved side effects from previous cancer treatments, except for hair loss or anemia.
- Have had major surgery within 21 days before starting the study.
- Have any significant medical conditions as specified in the study protocol.
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