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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05513703
Registration number
NCT05513703
Ethics application status
Date submitted
23/08/2022
Date registered
24/08/2022
Date last updated
15/04/2024
Titles & IDs
Public title
A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
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Scientific title
Phase 2, Open-Label Study in Subjects With Previously Untreated MET Amplified Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
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Secondary ID [1]
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2022-500608-23-00
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Secondary ID [2]
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M22-137
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Other interventions - Telisotuzumab Vedotin
Experimental: Telisotuzumab Vedotin - Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.
Other interventions: Telisotuzumab Vedotin
Intravenous (IV) Infusion
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective response rate (ORR) as Assessed by an Independent Central Review (ICR)
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Assessment method [1]
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ORR will be defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
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Timepoint [1]
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Up to 1 Year
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Secondary outcome [1]
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Duration of Response (DoR)
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Assessment method [1]
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DoR will be defined for confirmed responders as the time from the initial response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1, or death from any cause.
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Timepoint [1]
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Up to 1 Year
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Secondary outcome [2]
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Disease Control Rate (DCR)
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Assessment method [2]
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DCR will be defined as the percentage of participants with best overall response of confirmed CR or confirmed PR, or stable disease (SD) for at least 12 weeks following first dose of study drug, based on RECIST, version 1.1.
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Timepoint [2]
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Up to 1 Year
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Secondary outcome [3]
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Progression Free Survival (PFS) per ICR
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Assessment method [3]
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PFS will be defined as the time from the participant's first dose of study drug to the first occurrence of radiographic progression based on RECIST, version 1.1 or death from any cause.
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Timepoint [3]
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Up to 1 Year
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Secondary outcome [4]
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Overall Survival (OS)
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Assessment method [4]
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OS will be defined as the time from participant's first dose of study drug to the event of death from any cause.
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Timepoint [4]
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Up to 2 Years
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Secondary outcome [5]
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Time to Deterioration in Cough
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Assessment method [5]
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Time to deterioration in cough as measured by the cough items of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13).
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Timepoint [5]
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Up to 1 Year
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Secondary outcome [6]
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Time to Deterioration in Pain
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Assessment method [6]
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Time to deterioration in pain as measured by the cough items of the EORTC QLQ-LC13.
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Timepoint [6]
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Up to 1 Year
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Secondary outcome [7]
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Time to Deterioration in Dyspnea
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Assessment method [7]
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Time to deterioration in dyspnea as measured by the cough items of the EORTC QLQ-LC13.
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Timepoint [7]
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Up to 1 Year
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Secondary outcome [8]
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Time to Deterioration of Physical Functioning
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Assessment method [8]
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Time to deterioration of physical functioning as measured by the physical functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30).
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Timepoint [8]
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Up to 1 Year
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Secondary outcome [9]
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Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
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Assessment method [9]
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The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessing global health/quality of life and financial impact. Raw scores are transformed to a scale of 0 to 100, with higher scores representing better functioning/quality of life and greater symptom burden.
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Timepoint [9]
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Up to 1 Year
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Eligibility
Key inclusion criteria
- Must have MET amplification in tumor tissue as determined by the Sponsor-designated
central laboratory MET FISH Assay or in plasma and/or tissue by a Sponsor-approved
assay.
- Must have histologically documented non-squamous adenocarcinoma non-small cell lung
cancer (NSCLC) that is locally advanced or metastatic.
- Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST)
version 1.1.
- Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participant may have received prior adjuvant/neoadjuvant systemic chemotherapy and/or
radiation and/or immunotherapy provided that the subject has not progressed on or
within 6 months of completing the regimen and it was completed >= 6 months before
subject's first dose of study drug.
- Metastases to the central nervous system (CNS) are eligible only after definitive
therapy is provided as noted in the protocol.
- History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Alterations in EGFR, ALK, ROS1, or BRAF that predict sensitivity to available targeted
therapy. Participants with other alterations that are candidates for available
targeted therapy.
- Prior systemic therapy for locally advanced/metastatic NSCLC. Of note, limited
treatment with no more than 1 cycle of chemotherapy is allowed prior to receiving the
first dose of study drug provided there is no evidence of progression.
- Have a history of other malignancies except those noted in the protocol.
- Have a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g.,
bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or
evidence of active pneumonitis on screening chest computed tomography (CT) scan.
- Received prior c-Met-targeted antibodies.
- Have NSCLC that is eligible for treatment with curative intent.
- Have unresolved adverse events (AEs) >= Grade 2 from prior anticancer therapy, except
for alopecia or anemia.
- Have had major surgery within 21 days prior to the first dose of telisotuzumab
vedotin.
- Have clinically significant condition(s) as noted in the protocol.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/11/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/03/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
9
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Medical Centre /ID# 247679 - Clayton
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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Washington
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France
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State/province [3]
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Hauts-de-France
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France
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State/province [4]
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Rhone
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Country [5]
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France
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State/province [5]
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Clermont Ferrand
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Country [6]
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Germany
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State/province [6]
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Gauting
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Country [7]
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Israel
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State/province [7]
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H_efa
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Country [8]
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Israel
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State/province [8]
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HaMerkaz
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Country [9]
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Israel
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State/province [9]
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Tel-Aviv
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Israel
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State/province [10]
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Yerushalayim
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Country [11]
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Italy
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State/province [11]
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Monza E Brianza
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Country [12]
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Italy
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State/province [12]
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Torino
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Country [13]
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Italy
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State/province [13]
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Rome
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Country [14]
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Japan
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State/province [14]
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Chiba
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Country [15]
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Japan
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State/province [15]
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Fukuoka
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Country [16]
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Japan
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State/province [16]
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Hokkaido
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Country [17]
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Japan
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State/province [17]
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Osaka
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Country [18]
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Japan
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State/province [18]
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Shizuoka
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Country [19]
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Japan
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State/province [19]
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Tokyo
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Country [20]
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Korea, Republic of
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State/province [20]
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Gyeongsangnamdo
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Country [21]
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Korea, Republic of
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State/province [21]
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Cheongju
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Country [22]
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Korea, Republic of
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State/province [22]
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Daegu
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Country [23]
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Korea, Republic of
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State/province [23]
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Seoul
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Country [24]
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Taiwan
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State/province [24]
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Kaohsiung
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Taiwan
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State/province [25]
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Tainan
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Country [26]
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Taiwan
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State/province [26]
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Taoyuan City
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Cancer is a condition where cells in a specific part of body grow and reproduce
uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which
cancer cells form in the tissues of the lung. The purpose of this study is to determine how
telisotuzumab vedotin affects the disease state in adult participants with previously
untreated participants with MET amplified non-squamous NSCLC. Change in disease activity will
be assessed.
Telisotuzumab vedotin is an investigational drug being developed for the treatment of MET
amplified non-squamous NSCLC. Participants receive intravenously (IV) infused of
telisotuzumab vedotin. Approximately 70 adult participants with previously untreated MET
amplified locally advanced/metastatic non-squamous NSCLC will be enrolled in the study in
approximately 110 sites worldwide.
Participants will receive IV telisotuzumab vedotin every 2 weeks until meeting study drug
discontinuation criteria.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital or
clinic. The effect of the treatment will be checked by medical assessments, blood tests,
checking for side effects and completing questionnaires.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05513703
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05513703
Download to PDF