Study on Telisotuzumab Vedotin and Osimertinib for Treating Progressive, Incurable Non-Small Cell Lung Cancer
Sponsor: Jonsson Comprehensive Cancer Center
ClinicalTrials ID:NCT07323641
This clinical trial is exploring the effectiveness of combining two drugs, telisotuzumab vedotin and osimertinib, to treat non-small cell lung cancer that is worsening and cannot be cured with current treatments.
Patient Parameters
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Program Overview
This study is testing a new treatment for non-small cell lung cancer (NSCLC) that is getting worse and cannot be cured. The treatment combines two drugs: telisotuzumab vedotin, which targets specific molecules on cancer cells to deliver a toxic agent that kills them, and osimertinib, which blocks enzymes needed for cancer cell growth. The goal is to see if this combination can effectively treat this type of lung cancer.
Description
The main goals of this study are to see how well the treatment works in shrinking tumors and to measure how long patients live without the cancer getting worse. Researchers will also look at how long the treatment's effects last and how safe it is for patients.
Patients will receive telisotuzumab vedotin through an IV on specific days of each treatment cycle and take osimertinib pills daily. Each cycle lasts 28 days, and treatment continues as long as it is effective and safe. Patients will have regular scans and blood tests to monitor their progress and may have optional tumor biopsies.
After finishing the treatment, patients will have follow-up visits to check their health and the cancer's status for up to two years.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older with incurable non-small cell lung cancer (NSCLC) that has specific EGFR mutations.
- Cancer must have progressed on osimertinib treatment.
- Cancer cells must show high levels of a marker called c-MET.
- Must have measurable disease and be in good overall health.
- Must be able to swallow pills and have no known allergies to the study drugs.
- Must have adequate blood counts and organ function.
- Women of childbearing potential must use effective contraception and have a negative pregnancy test.
- Men must use barrier contraception if their partner is of childbearing potential.
- Must agree not to donate sperm or eggs during and after the study for a specified period.
Exclusion Criteria
- Currently participating in another clinical trial.
- Previous treatment with certain c-MET targeted therapies.
- Recent chemotherapy, immunotherapy, or radiation therapy.
- Active or untreated brain metastases.
- Unresolved side effects from previous cancer treatments.
- History of certain lung diseases or active lung inflammation.
- Recent major surgery or serious trauma.
- Active infections requiring IV antibiotics.
- History of another cancer within the last two years, except for certain treated cancers.
- Serious uncontrolled medical conditions or infections.
- Unable to comply with study requirements or any condition that may interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | 90095 | Los Angeles | California |
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