Telisotuzumab Vedotin + Osimertinib for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial tests how well telisotuzumab vedotin and osimertinib works for the treatment of non small cell lung cancer that is growing, spreading, or getting worse (progressive) and for which no treatment is currently available (incurable). Telisotuzumab vedotin is a monoclonal antibody, called telisotuzumab, linked to a toxic agent, called vedotin. Telisotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as c-Met receptors, and delivers vedotin to kill them. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving telisotuzumab vedotin and osimertinib may be effective for treating progressive, incurable non small cell lung cancer.
Who Is on the Research Team?
Jonathan W Goldman, MD
Principal Investigator
UCLA / Jonsson Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with a specific type of lung cancer (adenocarcinoma) that has worsened despite treatment with osimertinib. Participants must have tumors overexpressing c-Met, be able to swallow pills, and have good organ function and performance status. Those with certain mutations known to resist osimertinib or other histologies like squamous cell are excluded.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive telisotuzumab vedotin IV on days 1 and 15 of cycles 1-3 and on day 1 of subsequent cycles, and osimertinib PO daily on days 1-28. Cycles repeat every 28 days.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with optional tumor biopsy.
What Are the Treatments Tested in This Trial?
Interventions
- Osimertinib
- Telisotuzumab Vedotin
Trial Overview
The trial tests telisotuzumab vedotin combined with osimertinib in treating progressive, incurable non-small cell lung cancer. Telisotuzumab targets tumor cells while delivering a toxic agent to kill them; osimertinib blocks enzymes needed for tumor growth. The study includes CT and MRI scans, biopsies, and biospecimen collection.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive telisotuzumab vedotin IV on days 1 and 15 of cycles 1-3 and on day 1 of subsequent cycles. Patients also receive osimertinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, brain MRI, if needed, and blood sample collection throughout the study. Patients also optionally undergo tumor biopsy during follow-up.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer Center
Lead Sponsor
AbbVie
Industry Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois
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