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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02300831
Registration number
NCT02300831
Ethics application status
Date submitted
18/11/2014
Date registered
25/11/2014
Date last updated
14/07/2017
Titles & IDs
Public title
LUMINIST: LUng Cancer Molecular Insights Non Interventional Study
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Scientific title
LUMINIST: LUng Cancer Molecular Insights Non Interventional Study
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Secondary ID [1]
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D1532R00004
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Universal Trial Number (UTN)
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Trial acronym
LUMINIST
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
NSCLC
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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
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - Data Collection
NSCLC - The eligible patient population of this study will comprise of advanced 2nd line NSCLC patients who are screened for two randomised clinical trials (RCTs) sponsored by AstraZeneca (AZ): SELECT-1 and SELECT-2 trials, but who do not meet eligibility criteria for those trials
Other interventions: Data Collection
Non interventional prospective data collection
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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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Overall survival (OS)
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Assessment method [1]
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The Overall Survival will be calculated from the first date of each line of therapy to end of follow-up or death, whichever occurs first.
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Timepoint [1]
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Up to 34 months
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Secondary outcome [1]
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Progression Free survival (PFS)
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Assessment method [1]
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The length of time during and after the treatment of NSCLC that a patient lives with the disease but it does not progress (as defined by the Investigator).
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Timepoint [1]
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Up to 34 months
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Secondary outcome [2]
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Time to progression (TTP)
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Assessment method [2]
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The Time to Progression will be measured as the time from the first date of each line of therapy until the first date of documented disease progression. Time to Progression will be censored at the last tumour assessment available.
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Timepoint [2]
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Up to 34 months
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Secondary outcome [3]
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Duration of response (DOR) (complete or partial)
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Assessment method [3]
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The Duration of Response will be calculated as the time from the first documented complete response or partial response (whichever status is recorded first) until the first date of documented recurrence or progressive disease or death.
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Timepoint [3]
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Up to 34 months
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Secondary outcome [4]
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Complete response to treatment
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Assessment method [4]
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The complete response to treatment will be calculated as the percentage of patients per line of therapy having a complete response.
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Timepoint [4]
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Up to 34 months
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Secondary outcome [5]
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Healthcare resource utilisation (HRU)
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Assessment method [5]
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The number of hospitalisations, emergency room and outpatient visits, and the proportion of patients with a caregiver will be estimated.
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Timepoint [5]
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Up to 34 months
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Secondary outcome [6]
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Patients' characteristics
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Assessment method [6]
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The characteristics of the patients (Demographics (age, gender) smoking status, known mutations, tumour status and line of therapy) will be summarized descriptively by line of therapy.
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Timepoint [6]
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Up to 34 months
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Eligibility
Key inclusion criteria
1. Provision of informed consent from the patient or next-of-kin for deceased patient at study entry, where this is mandated by local regulations
2. Female and male adults (according to each country regulations for age of majority)
3. Patients who are not eligible or choose not to enter selumetinib SELECT-1 or SELECT-2 trials
4. Patients with confirmed histological diagnosis of NSCLC
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Minimum age
No limit
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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
1. Involved in the planning and/or conduct of this study (applies to both AZ staff and/or staff at the study site)
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
1/12/2014
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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
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Actual
30/06/2016
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Sample size
Target
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Accrual to date
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Final
770
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Camperdown
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Research Site - Darlinghurst
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Recruitment hospital [3]
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Research Site - Kurralta Park
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Recruitment hospital [4]
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Research Site - Wendouree
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- Camperdown
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Recruitment postcode(s) [2]
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- Darlinghurst
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Recruitment postcode(s) [3]
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- Kurralta Park
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Recruitment postcode(s) [4]
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- Wendouree
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Austria
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Salzburg
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Belgium
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Bruxelles
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Roeselare
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Edmonton
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Halle-Saale
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Koeln
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Loewenstein
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Moers
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Muenchen
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Ulm
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Kaposvar
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Miskolc
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Kfar-Saba
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Kharkiv
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Kryvyi Rih, Dnipropetrovsk Region
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Kyiv
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Sumy
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Uzhgorod
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Aberdeen
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Nottingham
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United Kingdom
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Quintiles, Inc.
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Ethics approval
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Summary
Brief summary
The recent development of therapies targeting specific biomarkers mutations is changing the standards of care and prognosis of patients with advanced NSCLC, but very few data are currently available on those emerging biomarkers. In addition, the correlation of biomarkers with patients' clinical outcomes in a standard of care setting is poorly understood. This study aims to address that need.
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Trial website
https://clinicaltrials.gov/study/NCT02300831
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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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Gabriella Mariani, MD
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Address
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AstraZeneca UK, MSD
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Contact person for scientific queries
No information has been provided regarding IPD availability
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/NCT02300831
Download to PDF