Telisotuzumab Vedotin and Osimertinib for Incurable Non-Small Cell Lung Cancer
This study is testing a combination of two drugs, telisotuzumab vedotin and osimertinib, for people with non-small cell lung cancer that is growing or spreading and for which other treatments haven't worked. Telisotuzumab vedotin is a targeted therapy that attaches to specific markers (c-Met receptors) on cancer cells to deliver a cancer-killing agent. Osimertinib works by blocking enzymes that help cancer cells grow. Researchers want to see how well this combination shrinks tumors and prevents the cancer from getting worse. You may be able to join if you are 18 or older, have non-small cell lung cancer with a specific EGFR mutation (excluding exon 20 insertions), and are willing to provide informed consent. The study aims to enroll 60 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study planning to enroll 60 participants. It is testing the combination of telisotuzumab vedotin and osimertinib.
- What's involved
- You would undergo a tumor biopsy, blood sample collection, CT scans, and MRI scans. You would also receive the study drugs, osimertinib (taken by mouth).
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track how long it takes for your cancer to progress or for you to pass away, for up to 2 years.
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NCT07323641
Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentJonsson Comprehensive Cancer CenterInvestigator-initiated
~60 participants
Updated 2026-04-20 on ClinicalTrials.gov
What's tested:Biopsy ProcedureBiospecimen CollectionComputed TomographyMagnetic Resonance ImagingOsimertinibSurvey Administration
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate (ORR)
Measured over Up to 2 years
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Jonathan W Goldman, MD · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Male or female ≥ 18 years of age and willing and able to provide informed consent
Cytologically or histologically confirmed non small cell lung cancer (NSCLC), which is incurable with an activating and sensitizing EGFR mutation (e.g., exon 20 insertion mutations are excluded). Enrollment of patients with mutations other than exon 19 deletion and the L858R point mutation require literature supporting sensitivity to osimertinib. T790M mutations and identified EGFR mutations that are known to confer resistance to osimertinib (for instance C797S) are allowed
Predominantly adenocarcinoma histology. (Small cell or predominantly squamous cell or sarcomatoid/pleiomorphic histologies are excluded.)
Progressed on osimertinib. Osimertinib must have been included in the last systemic therapy prior to trial enrollment and the patient must be considered appropriate for continuation of osimertinib at 80 mg daily per the treating investigator
From a tumor specimen obtained following progression on osimertinib or within 4 months of study entry (as long as the specimen was obtained after osimertinib was started), subjects must have c-MET overexpressing NSCLC as assessed by a Certified Laboratory Improvement Amendments (CLIA)-certified laboratory using the VENTANA MET (SP44) RxDx assay, with intermediate or high expression, defined as either ≥ 25% and \< 50% (intermediate) or ≥ 50% (high). If local results are unavailable, central testing may be performed
Measurable disease, as per RECIST 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Able to swallow the oral study drug, has no known intolerance of study drugs or excipients, and able to comply with study requirements
Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L
Platelets ≥ 100 × 10\^9/L
Hemoglobin ≥ 9 g/dL
Serum creatinine ≤1.5 X upper limit of normal (ULN) OR measured or calculated\* creatinine clearance ≥ 50 mL/min (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\])
Creatinine clearance may be calculated using a 24 hour urine collection, by the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) per the Modification of Diet in Renal Disease (MDRD) GFR equation
Serum total bilirubin ≤ 1.5 X ULN OR direct bilirubin ≤ ULN
Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 2.5 X ULN OR ≤ 5 X ULN for participants with liver metastases
Albumin ≥ 3.0 g/dL
Female participants of childbearing potential must have a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum test must be negative for pregnancy for the participant to be eligible. Female participants must agree to use a highly effective method of contraception from the beginning of screening until 7 months after the last dose of the telisotuzumab vedotin, or be of nonchildbearing potential.Nonchildbearing potential is defined as follows (by other than medical reasons):
≥ 45 years of age and has not had menses for \> 2 years, in the absence of conditions that could lead to amenorrhea (i.e., post chemotherapy),
Participants who have been amenorrhoeic for \< 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation, or
Surgical sterilization (Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation)
Male patients having sex with a female partner of childbearing potential or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 4 months after the last dose of telisotuzumab vedotin
Male and female participants must agree not to donate sperm or eggs, respectively starting from the first study-drug treatment, Men must not donate sperm during trial therapy and for 4 months after receiving the last dose of study medication and women must not donate eggs during trial treatment and for 7 months after receiving the last dose of study medication
Subjects with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for the study
Subject must not have a history of idiopathic lung disease, drug-induced idiopathic lung disease, idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, radiation pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
Major surgical procedures or serious trauma within 4 weeks prior to cycle (C) 1 day (D) 1, or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) do not require a washout
The patient has any ongoing or active infection requiring the use of parenteral anti-microbial agents. Patient with a history of HIV with an undetectable viral load and a CD4 count over 200 are eligible. Patients with a history of hepatitis B or hepatitis C, an undetectable viral load, and liver function tests (LFT) testing which meets criteria for the study are eligible
History of another cancer within 2 years of study initiation, with the exception of fully treated cancers unlikely to affect the assessment of the study treatment safety or efficacy including early-stage breast, prostate, bladder, non-melanomatous skin, thyroid, cervical, or endometrial cancer. Additionally, subjects must not be receiving any ongoing anti-cancer therapy, including maintenance therapy, prior to randomization. Hormonal therapy is allowed provided that the participant otherwise meets trial criteria
Participants must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to uncontrolled ventricular arrhythmia, myocardial infarction within 6 months, stroke within 6 months, clinically significant electrocardiogram (ECG) abnormalities, any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as electrolyte abnormalities, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, clinically significant liver disease, including hepatitis, current alcohol abuse, or cirrhosis, grade ≥ 2 edema or lymphedema, grade ≥ 2 ascites or pleural effusion, grade ≥ 2 neuropathy, grade ≥ 2 corneal disorder as assessed by a baseline ophthalmic exam, or any psychiatric disorder that prohibits obtaining informed consent
Patient unwilling or unable to comply with the protocol
Any condition that, in the opinion of the investigator or sponsor-investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
Exclusion
Concurrent enrollment in another clinical study, unless enrolled only in the follow-up period or an observational study
Prior c-MET targeted antibody drug conjugate with a microtubule toxin (such as monomethylauristatin E \[MMAE\]). Prior MET antibody without a toxin, prior MET antibody drug conjugate (ADC) with a non-microtubule, and prior MET TKI therapy are acceptable
Any chemotherapy, immunotherapy, biologic, hormonal therapy, or investigational systemic therapy for cancer treatment in the prior 3 weeks or within 5 half-lives of the medication, whichever is shorter. Concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable
Thoracic radiation of ≥ 30 grey (Gy) within 6 months. Other radiation within 2 weeks with the exception: Stereotactic, palliative radiation for bone metastases is acceptable without a washout as long as no lung parenchyma was included in the radiation field
Progressive or symptomatic brain metastases. Brain metastases that have been radiated, are asymptomatic, and on a stable or decreasing dose of steroids are allowed. Leptomeningeal disease is excluded
What this trial measures
- Objective response rate (ORR)Up to 2 years
Defined as complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. The ORR estimate and its associated 95% confidence interval (CI) will be calculated.
- Progression free survival (PFS)From treatment initiation to disease progression per RECIST 1.1 criteria or death, up to 2 years
The Kaplan-Meier curve and its 95% CI will be used to infer the PFS. The median time PFS will be compared to median survival time of 4.2 months base on historic controls, using Brookmeyer-Crowley method.