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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04928846
Registration number
NCT04928846
Ethics application status
Date submitted
14/06/2021
Date registered
16/06/2021
Titles & IDs
Public title
A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
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Scientific title
A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
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Secondary ID [1]
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2023-505749-14-00
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Secondary ID [2]
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M18-868
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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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0
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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
Treatment: Other - Telisotuzumab Vedotin
Treatment: Drugs - Docetaxel
Experimental: Telisotuzumab Vedotin - Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.
Active comparator: Docetaxel - Participants will receive docetaxel every 3 weeks until meeting study drug discontinuation criteria.
Treatment: Other: Telisotuzumab Vedotin
Intravenous (IV) Infusion
Treatment: Drugs: Docetaxel
IV Infusion
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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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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Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)
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Assessment method [1]
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PFS is defined as the time from randomization to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) per BICR or death from any cause.
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Timepoint [1]
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Up to approximately 39 months
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS is defined as the time from randomization to the event of death from any cause.
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Timepoint [2]
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Up to approximately 39 months
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Secondary outcome [1]
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Objective Response Rate (ORR), per BICR.
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Assessment method [1]
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ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR) based on RECIST v1.1
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Timepoint [1]
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Up to approximately 58.25 months
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Secondary outcome [2]
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Duration of Response (DoR), per BICR
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Assessment method [2]
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DoR is defined for responders as the time from 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 [2]
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Up to approximately 58.25 months
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Secondary outcome [3]
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PFS per Investigator Assessment
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Assessment method [3]
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PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 per investigator or death from any cause. Participants with no PFS event will be censored at the last evaluable radiographic assessment per investigator. Participants with no event and no evaluable post-baseline assessment will be censored at randomization.
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Timepoint [3]
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Up to approximately 58.25 months
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Secondary outcome [4]
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Change from Baseline of Physical Functioning as measured by the Physical Functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30).
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Assessment method [4]
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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 [4]
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Up to approximately 12 Weeks
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Secondary outcome [5]
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Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-C30.
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Assessment method [5]
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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 [5]
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Up to approximately 12 Weeks
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Eligibility
Key inclusion criteria
* Projected life expectancy of at least 12 weeks.
* Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay.
* Archival or fresh tumor material must be submitted for assessment of c-Met levels during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed.
* If a participant was prescreened for Study M14-239 but did not enroll, tumor material previously submitted for Study M14-239 may be used for Study M18-868 Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor material is available (Except China).
* A histologically or cytologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
* A known epidermal growth factor receptor (EGFR) activating mutation status.
* Actionable alterations in genes other than EGFR .
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
* An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
* Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting.
* Neoadjuvant and adjuvant systemic cytotoxic chemotherapy will count as a prior line for eligibility purposes if progression occurred within 6 months of the end of therapy.
* Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC:
* Participants WITHOUT an actionable gene alteration: must have progressed on (or be considered ineligible for) platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
* Participants WITH an actionable gene alteration for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase [ALK] translocation): must have progressed on (or be considered ineligible for) anti-cancer therapy targeting driver gene alterations and platinum-based chemotherapy.
* Participants with actionable gene alterations for which immune checkpoint inhibitor is standard of care must have also progressed on (or be considered ineligible for) immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
* Must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.
* Participants with metastases to the central nervous system (CNS) are eligible only after adequate treatment (such as surgery, radiotherapy, or drug therapy) is provided and:
* They are asymptomatic and off or on a stable or reducing dose of systemic steroids (on no more than 10 mg per day [QD] prednisone or equivalent) and/or anticonvulsants for at least 2 weeks prior to randomization.
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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
* Evidence of new, untreated CNS metastases.
* Evidence of leptomeningeal disease.
* Participants with adenosquamous or neuroendocrine histology, nor sarcomatoid features.
* Actionable epidermal growth factor receptor (EGFR) activating mutations.
* Participants who have received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E..
* Participants who have received prior docetaxel therapy.
* A history of other malignancies except:
* Malignancy treated with curative intent and with no known active disease present for >=2 years before the first dose of study drug and felt to be at low risk for recurrence by investigator.
* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
* Adequately treated carcinoma in situ without current evidence of disease.
* 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. A history of prior radiation pneumonitis in the radiation field (fibrosis) is permitted.
* Unresolved or neuroendocrine histology, nor sarcomatoid features adverse event (AE) >= Grade 2 from prior anticancer therapy, except for alopecia or anemia. Participants with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for study.
* Major surgery within 21 days prior to randomization.
* Clinically significant condition(s) as listed in the protocol.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
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
25/03/2022
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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
21/03/2028
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Actual
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Sample size
Target
698
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Barwon Health /ID# 241920 - Geelong
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Recruitment hospital [2]
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Austin Health /ID# 247507 - Heidelberg
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Recruitment postcode(s) [1]
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3220 - Geelong
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3084 - Heidelberg
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Recruitment outside Australia
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Japan
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State/province [108]
0
0
Fukushima
Query!
Country [109]
0
0
Japan
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State/province [109]
0
0
Gunma
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Country [110]
0
0
Japan
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State/province [110]
0
0
Hiroshima
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Country [111]
0
0
Japan
Query!
State/province [111]
0
0
Hokkaido
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Country [112]
0
0
Japan
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State/province [112]
0
0
Hyogo
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Country [113]
0
0
Japan
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State/province [113]
0
0
Ibaraki
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Country [114]
0
0
Japan
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State/province [114]
0
0
Iwate
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Country [115]
0
0
Japan
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State/province [115]
0
0
Kanagawa
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Country [116]
0
0
Japan
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State/province [116]
0
0
Kumamoto
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Country [117]
0
0
Japan
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State/province [117]
0
0
Mie
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Country [118]
0
0
Japan
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State/province [118]
0
0
Miyagi
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Country [119]
0
0
Japan
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State/province [119]
0
0
Miyazaki
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Country [120]
0
0
Japan
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State/province [120]
0
0
Niigata
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Country [121]
0
0
Japan
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State/province [121]
0
0
Okayama
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Country [122]
0
0
Japan
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State/province [122]
0
0
Osaka
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Country [123]
0
0
Japan
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State/province [123]
0
0
Tochigi
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Country [124]
0
0
Japan
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State/province [124]
0
0
Tokyo
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Country [125]
0
0
Japan
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State/province [125]
0
0
Toyama
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Country [126]
0
0
Japan
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State/province [126]
0
0
Wakayama
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Country [127]
0
0
Japan
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State/province [127]
0
0
Yamagata
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Country [128]
0
0
Japan
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State/province [128]
0
0
Yamaguchi
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Country [129]
0
0
Korea, Republic of
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State/province [129]
0
0
Chungcheongbugdo
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Country [130]
0
0
Korea, Republic of
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State/province [130]
0
0
Gyeonggido
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Country [131]
0
0
Korea, Republic of
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State/province [131]
0
0
Gyeongsangnamdo
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Country [132]
0
0
Korea, Republic of
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State/province [132]
0
0
Seoul Teugbyeolsi
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Country [133]
0
0
Mexico
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State/province [133]
0
0
Jalisco
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Country [134]
0
0
Mexico
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State/province [134]
0
0
Michoacan
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Country [135]
0
0
Mexico
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State/province [135]
0
0
Oaxaca
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Country [136]
0
0
Netherlands
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State/province [136]
0
0
Zuid-Holland
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Country [137]
0
0
Poland
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State/province [137]
0
0
Lodzkie
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Country [138]
0
0
Poland
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State/province [138]
0
0
Podkarpackie
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Country [139]
0
0
Poland
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State/province [139]
0
0
Warminsko-mazurskie
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Country [140]
0
0
Portugal
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State/province [140]
0
0
Lisboa
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Country [141]
0
0
Portugal
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State/province [141]
0
0
Regiao Autonoma Da Madeira
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Country [142]
0
0
Portugal
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State/province [142]
0
0
Porto
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Country [143]
0
0
Romania
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State/province [143]
0
0
Bihor
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Country [144]
0
0
Romania
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State/province [144]
0
0
Cluj
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Country [145]
0
0
Romania
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State/province [145]
0
0
Iasi
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Country [146]
0
0
Romania
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State/province [146]
0
0
Ilfov
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Country [147]
0
0
Romania
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State/province [147]
0
0
Olt
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Country [148]
0
0
Romania
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State/province [148]
0
0
Timis
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Country [149]
0
0
Romania
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State/province [149]
0
0
Suceava
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Country [150]
0
0
Slovakia
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State/province [150]
0
0
Bratislavsky Kraj
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Country [151]
0
0
South Africa
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State/province [151]
0
0
Gauteng
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Country [152]
0
0
Spain
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State/province [152]
0
0
Burgos
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Country [153]
0
0
Spain
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State/province [153]
0
0
Las Palmas
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Country [154]
0
0
Spain
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State/province [154]
0
0
Madrid
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Country [155]
0
0
Spain
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State/province [155]
0
0
Barcelona
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Country [156]
0
0
Spain
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State/province [156]
0
0
Jaen
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Country [157]
0
0
Spain
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State/province [157]
0
0
Valencia
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Country [158]
0
0
Sweden
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State/province [158]
0
0
Stockholms Lan
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Country [159]
0
0
Sweden
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State/province [159]
0
0
Vastra Gotalands Lan
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Country [160]
0
0
Taiwan
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State/province [160]
0
0
Keelung
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Country [161]
0
0
Taiwan
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State/province [161]
0
0
Taipei
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Country [162]
0
0
Taiwan
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State/province [162]
0
0
Changhua City, Changhua County
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Country [163]
0
0
Taiwan
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State/province [163]
0
0
Hsinchu City
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Country [164]
0
0
Taiwan
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State/province [164]
0
0
Hualien City
Query!
Country [165]
0
0
Taiwan
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State/province [165]
0
0
Taipei City
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Country [166]
0
0
Turkey
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State/province [166]
0
0
Adana
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Country [167]
0
0
Turkey
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State/province [167]
0
0
Ankara
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Country [168]
0
0
Turkey
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State/province [168]
0
0
Izmir
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Country [169]
0
0
Turkey
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State/province [169]
0
0
Battalgazi/malatya
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Country [170]
0
0
Turkey
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State/province [170]
0
0
Bursa
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Country [171]
0
0
Turkey
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State/province [171]
0
0
Diyarbakir
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Country [172]
0
0
Turkey
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State/province [172]
0
0
Istanbul
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Country [173]
0
0
United Kingdom
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State/province [173]
0
0
London, City Of
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Country [174]
0
0
United Kingdom
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State/province [174]
0
0
Nottinghamshire
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Country [175]
0
0
United Kingdom
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State/province [175]
0
0
Birmingham
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Country [176]
0
0
United Kingdom
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State/province [176]
0
0
London
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Country [177]
0
0
United Kingdom
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State/province [177]
0
0
Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
AbbVie
Query!
Address
Query!
Country
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Ethics approval
Ethics application status
Query!
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 if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. Change in disease activity and adverse events will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of Teliso-V or Docetax at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 698 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 300 sites worldwide. Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 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/study/NCT04928846
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
ABBVIE INC.
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Address
0
0
AbbVie
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Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
ABBVIE CALL CENTER
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
844-663-3742
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Fax
0
0
Query!
Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Query!
Available to whom?
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04928846