Actively Recruiting
Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer
Led by Jonsson Comprehensive Cancer Center · Updated on 2026-04-20
60
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
Sponsors
J
Jonsson Comprehensive Cancer Center
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years or older able to provide informed consent
- Confirmed non small cell lung cancer with an activating EGFR mutation, excluding exon 20 insertion mutations
- Predominantly adenocarcinoma histology
- Disease progression on osimertinib as the last systemic therapy
- Tumor specimen after osimertinib showing c-MET overexpression by certified testing
- Measurable disease per RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Able to swallow oral study drug and comply with study requirements
- Absolute neutrophil count 1.5 x 10^9/L or higher
- Platelets 100 x 10^9/L or higher
- Hemoglobin 9 g/dL or higher
- Serum creatinine less than or equal to 1.5 times upper limit of normal or creatinine clearance at least 50 mL/min
- Serum total bilirubin less than or equal to 1.5 times upper limit of normal or direct bilirubin within normal limits
- AST and ALT less than or equal to 2.5 times upper limit of normal or up to 5 times if liver metastases present
- Albumin 3.0 g/dL or higher
- Female participants of childbearing potential must have a negative pregnancy test and use effective contraception or be nonchildbearing
- Male participants with female partners of childbearing potential must use barrier contraception during treatment and for 4 months after
- Participants must agree not to donate sperm or eggs during treatment and for specified periods after last dose
You will not qualify if you...
- Enrollment in another clinical study except follow-up or observational studies
- Prior treatment with c-MET targeted antibody drug conjugates with microtubule toxin
- Cancer treatment including chemotherapy, immunotherapy, biologics, or investigational therapy within 3 weeks prior to study or within 5 half-lives
- Thoracic radiation of 30 gray or more within 6 months
- Progressive or symptomatic brain metastases or leptomeningeal disease
- Unrecovered toxicities from prior therapy except alopecia or lab abnormalities meeting criteria
- History of idiopathic or drug-induced lung diseases or active pneumonitis
- Major surgery or serious trauma within 4 weeks prior to first treatment or planned during first 4 weeks
- Active infections requiring intravenous antibiotics
- History of another cancer within 2 years except certain treated cancers without ongoing therapy
- Poor medical risk due to serious uncontrolled disorders or infections
- Inability or unwillingness to comply with protocol
- Any condition interfering with investigational product evaluation or safety assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
K
Kim Kelly
CONTACT
J
James Chauv
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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