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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03539536
Registration number
NCT03539536
Ethics application status
Date submitted
17/05/2018
Date registered
29/05/2018
Titles & IDs
Public title
Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer
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Scientific title
Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects With Previously Treated c-Met+ Non-Small Cell Lung Cancer
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Secondary ID [1]
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2023-507902-15-00
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Secondary ID [2]
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M14-239
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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: Drugs - Telisotuzumab vedotin
Experimental: Telisotuzumab vedotin - Telisotuzumab vedotin administered via intravenous (IV) infusion every 14 days.
Treatment: Drugs: Telisotuzumab vedotin
Intravenous (IV) infusion
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Intervention code [1]
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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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Overall Response Rate (ORR) (Stage 1 and Stage 2)
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Assessment method [1]
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ORR is 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 approximately 3 years
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Primary outcome [2]
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Number of Participants with Adverse Events (Alternate dose cohort)
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Assessment method [2]
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An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
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Timepoint [2]
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Up to approximately 3 years
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Secondary outcome [1]
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Duration of Response (DoR) (Stage 1 and Stage 2)
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Assessment method [1]
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DoR is defined as the time from the participant's initial response (CR or PR) to the first occurrence of radiographic progression determined by an independent central review or death from any cause for the responders.
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Timepoint [1]
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Up to approximately 3 years
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Secondary outcome [2]
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Disease Control Rate (DCR) (Stage 1 and Stage 2)
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Assessment method [2]
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DCR is defined as the percentage of participants with best overall response of confirmed CR, confirmed PR, or stable disease (SD) for at least 12 weeks following enrollment, based on RECIST, version 1.1.
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Timepoint [2]
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Up to approximately 3 years
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Secondary outcome [3]
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Progression-Free Survival (PFS) (Stage 1 and Stage 2)
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Assessment method [3]
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PFS is defined as the time from the participant's first dose of study drug until the first occurrence of radiographic progression determined by an independent central review or death from any cause.
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Timepoint [3]
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Up to approximately 3 years
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Secondary outcome [4]
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Overall Survival (OS) (Stage 1 and Stage 2)
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Assessment method [4]
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OS is defined as the time from the participant's first dose of study drug until death from any cause.
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Timepoint [4]
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Up to approximately 3 years
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Eligibility
Key inclusion criteria
* Have locally advanced or metastatic non-small cell lung cancer (NSCLC).
* Have c-Met+ NSCLC as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory. Participant must submit archival or fresh tumor material for assessment of c-Met levels during the prescreening period. Tumor material from the primary tumor site and/or metastatic sites are allowed. If archival tissue is negative for c-Met overexpression, subject can submit fresh biopsy material for reassessment of c-Met expression.
* Histologically documented non-squamous epidermal growth factor receptor (EGFR) wild type NSCLC (site documented EGFR status). Of note, subjects with other actionable mutations are eligible as long as EGFR status is known and all other eligibility criteria are met. As of Protocol Version 11, Stage 1 is complete and Stage 2 is enrolling participants with non-squamous EGFR wild type NSCLC only.
* Must have received no more than 2 lines of prior systemic therapy (including no more than 1 line of systemic cytotoxic chemotherapy) in the locally advanced or metastatic setting.
* Multiple lines of tyrosine kinase inhibitors (TKIs) targeting the same tyrosine kinase (TK) count as 1 line of therapy for the purposes of this eligibility criterion.
* Progressed on systemic cytotoxic therapy (or are ineligible for systemic cytotoxic chemotherapy) and an immune checkpoint inhibitor (as monotherapy or in combination with systemic cytotoxic chemotherapy, or ineligible), and prior anticancer therapies targeting driver gene alterations (if applicable).
* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
* Treatment with any therapies within the noted time intervals is excluded prior to the first dose of telisotuzumab vedotin as noted in the protocol.
* Metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided within the protocol.
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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
* Have received radiation therapy to the lungs < 6 months prior to the first dose of telisotuzumab vedotin.
* Have received any live vaccine within 30 days of the first dose of investigational product.
* Has adenosquamous histology.
* Have a history of other malignancies except those noted within the protocol.
* Have a history of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids.
* Have any evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or ILD within 3 months of the planned first dose of the study drug (Except for Sites in Ireland). For imaging findings deemed clinically insignificant by the treating physician, subject may be eligible after discussion with and approval from the AbbVie medical monitor.
* For Sites in Ireland Only: Must not have any evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or ILD. For imaging findings deemed clinically insignificant by the treating physician, subject may be eligible after discussion with and approval from the AbbVie medical monitor.
* Have a clinically significant condition(s) as noted in the protocol.
* Have unresolved clinically significant adverse events of 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.
* For Sites in France and Czech Republic Only: Have the following:
* Known human immunodeficiency virus (HIV) infection. Note: HIV testing is not required for eligibility for this protocol unless mandated by local regulatory authority or ethics committee/institutional review board.
* Active hepatitis B virus (HBV) infection, defined by hepatitis B surface antigen (HBsAg) positivity or HBV DNA >= 500 IU/mL. In participants with known HBV infection, the presence of active infection must be tested locally. If HBV status is unknown, it must be tested locally at screening.
* Active hepatitis C virus (HCV) infection, defined by HCV ribonucleic acid (RNA) positivity. Participants cured of HCV infection may be included in the study. In participants with known HCV infection, the presence of active infection must be tested locally. If HCV status is unknown, it must be tested locally at screening.
* Uncontrolled autoimmune disease.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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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
10/10/2018
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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
6/10/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
270
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
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Recruitment hospital [1]
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The Kinghorn Cancer Centre /ID# 207666 - Darlinghurst
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Newcastle Private Hospital /ID# 206600 - Lambton Heights
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The Tweed Hospital /ID# 206601 - Tweed Heads
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Mater Misericordiae Limited /ID# 229639 - South Brisbane
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St John Of God Subiaco Hospital /ID# 226943 - Subiaco
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2010 - Darlinghurst
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2305 - Lambton Heights
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2485 - Tweed Heads
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4101 - South Brisbane
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6008 - Subiaco
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Japan
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State/province [116]
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Saitama
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Country [117]
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Japan
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State/province [117]
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0
Shizuoka
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Country [118]
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Japan
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State/province [118]
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Tokyo
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Japan
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State/province [119]
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Yamaguchi
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Japan
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0
Fujieda-shi
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Japan
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Hiroshima-shi
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Korea, Republic of
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Gyeonggido
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Country [123]
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Korea, Republic of
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Gyeongsangnamdo
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Korea, Republic of
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Cheongju
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Korea, Republic of
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Incheon
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Korea, Republic of
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Jeonnam
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Korea, Republic of
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Seoul
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Netherlands
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Noord-Holland
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Netherlands
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Amersfoort
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Netherlands
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Harderwijk
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Poland
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State/province [131]
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Lodzkie
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Country [132]
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Poland
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Mazowieckie
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Country [133]
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Poland
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State/province [133]
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Podkarpackie
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Poland
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Wielkopolskie
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Poland
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Zachodniopomorskie
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Puerto Rico
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San Juan
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Romania
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Dolj
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Romania
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Prahova
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Country [139]
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Romania
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Bucharest
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Romania
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Cluj Napoca
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Country [141]
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Romania
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State/province [141]
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Timisoara
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Country [142]
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Russian Federation
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State/province [142]
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Krasnoyarskiy Kray
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Country [143]
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Russian Federation
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Novosibirskaya Oblast
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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Tatarstan, Respublika
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Country [146]
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Russian Federation
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Volgogradskaya Oblast
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Russian Federation
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Arkhangelsk
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Russian Federation
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Chelyabinsk
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Russian Federation
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Kostroma
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Russian Federation
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Moscow
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Country [151]
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Russian Federation
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Obninsk
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Russian Federation
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State/province [152]
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Omsk
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Russian Federation
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Pushkin
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Country [154]
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Russian Federation
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State/province [154]
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Pyatigorsk
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Country [155]
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Russian Federation
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State/province [155]
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St. Petersburg
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Country [156]
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Spain
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State/province [156]
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A Coruna
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Country [157]
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Spain
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State/province [157]
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Barcelona
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Country [158]
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Spain
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State/province [158]
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Las Palmas
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Country [159]
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Spain
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Madrid
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Country [160]
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Spain
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Avila
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Spain
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Malaga
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Country [162]
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Spain
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Sevilla
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Country [163]
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Spain
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State/province [163]
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Valencia
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Country [164]
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Switzerland
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Basel-Stadt
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Switzerland
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Zuerich
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Country [166]
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Taiwan
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State/province [166]
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Kaohsiung
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Country [167]
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0
Taiwan
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State/province [167]
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Chia-Yi
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Country [168]
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Taiwan
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State/province [168]
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New Taipei City
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Country [169]
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Taiwan
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State/province [169]
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Taichung
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Country [170]
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Taiwan
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Tainan
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Taiwan
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State/province [171]
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Taipei City
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Taiwan
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Taipei
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Taiwan
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Taoyuan City
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Country [174]
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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Edirne, Istanbul
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Turkey
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Istanbul
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Turkey
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Izmir
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United Kingdom
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State/province [180]
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London, City Of
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Country [181]
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United Kingdom
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State/province [181]
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Nottinghamshire
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Country [182]
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United Kingdom
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Oxfordshire
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Country [183]
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United Kingdom
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0
Birmingham
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Country [184]
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0
United Kingdom
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State/province [184]
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0
London
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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
This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that overexpress c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage 2). After the Stage 2 global enrollment is completed, an additional cohort at an alternate dose level will evaluate the safety and efficacy of telisotuzumab vedotin (Stage 3).
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Trial website
https://clinicaltrials.gov/study/NCT03539536
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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
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0
AbbVie
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
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Address
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Fax
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Email
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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
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What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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/
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Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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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/NCT03539536