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Lung Non-Small Cell CarcinomaPhase 2NCT07323641

Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer

A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Computed Tomography in people with Lung Non-Small Cell Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Non-Small Cell Carcinoma
What is being tested?
Biopsy Procedure, Biospecimen Collection and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
19 Feb 2026to 1 Feb 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
  • Has not recovered (recovery is defined as National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events [CTCAE v 5.0] grade ≤ 1) from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting the inclusion requirements stated in the inclusion criterion. Other grade 2 or less toxicities not constituting a safety risk based on the investigator's judgment are acceptable.
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kim Kelly contact

310-206-8309

KMKelly@mednet.ucla.edu

James Chauv contact

310-747-7445

JChauv@mednet.ucla.edu

United States1 site, 1 recruiting

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

    James Chaov, 310-747-7445, JChauv@mednet.ucla.edu

    Kim Kelly, 310-206-8309, kmkelly@mednet.ucla.edu

    Recruiting

Other trials in United States

About this study

Official title: A Phase II Trial of Telisotuzumab Vedotin With Osimertinib for EGFR Mutated NSCLC With c-MET Overexpression That is Progressing on Osimertinib

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Objective response rate (ORR) as defined as complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.

II. Progression free survival (PFS) as defined by time from treatment initiation to disease progression per RECIST 1.1 criteria or death.

SECONDARY OBJECTIVES:

  1. Duration of response (DOR), time to response (TTR) and overall survival (OS).

II. Assess the safety and tolerability of induction and maintenance schedule of telisotuzumab vedotin when given with osimertinib in all evaluable patients who received at least one dose of study regimen.

EXPLORATORY OBJECTIVES:

  1. Assess potential biomarkers associated with response from liquid biopsies and archival or fresh tissue biopsy.

Ia. Correlate tissue biomarkers such as MET expression level by immunohistochemistry and ribonucleic acid (RNA) expression with response; Ib. Where an archival specimen is available from prior to treatment with an EGFR tyrosine kinase inhibitor (TKI) and can be compared to a more recent specimen, the dynamics and predictive value of c-MET overexpression will be evaluated.

II. Assess participant-reported outcomes on quality of life using Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS) questionnaire.

OUTLINE:

Patients receive telisotuzumab vedotin intravenously (IV) on days 1 and 15 of cycles 1-3 and on day 1 of subsequent cycles. Patients also receive osimertinib orally (PO) daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan, brain magnetic resonance imaging (MRI), if needed, and blood sample collection throughout the study. Patients also optionally undergo tumor biopsy during follow-up.

After completion of study treatment, patients are followed up at 30 days and every 6 weeks or 12 weeks for up to 2 years.

Being tested
Biopsy Procedure, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Osimertinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE, Bx

    Undergo tumor biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • OsimertinibDrug

    Also called AZD 9291, AZD-9291, AZD9291, Mereletinib

    Given PO

  • Survey AdministrationOther

    Ancillary studies

  • Telisotuzumab VedotinBiological

    Also called ABBV 399, ABBV-399, ABT 399, ABT-399

    Given IV

Study groups in NCT07323641
Study groupRoleWhat they receive
Treatment (telisotuzumab vedotin and osimertinib)ExperimentalPatients 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.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Drug: Osimertinib; Other: Survey Administration; Biological: Telisotuzumab Vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    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.

    Measured: Up to 2 years

  2. Progression free survival (PFS)

    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.

    Measured: From treatment initiation to disease progression per RECIST 1.1 criteria or death, up to 2 years

Secondary outcomes (3)

  1. Duration of response

    The Kaplan-Meier curve and its 95% CI will be used to infer the endpoint.

    Measured: From documentation of tumor response to disease progression, up to 2 years

  2. Time to response

    The Kaplan-Meier curve and its 95% CI will be used to infer the endpoint.

    Measured: From treatment initiation until documentation of tumor response, up to 2 years

  3. Overall survival

    The Kaplan-Meier curve and its 95% CI will be used to infer the endpoint.

    Measured: From randomization to death by any cause, up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2026
  2. Study start19 Feb 2026
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07323641
Sponsor's protocol ID
25-2145
Other IDs
NCI-2025-09155
Status last verified
Apr 2026
First submitted
6 Jan 2026
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Computed Tomography in people with Lung Non-Small Cell Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kim Kelly (310-206-8309, KMKelly@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07323641.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.

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