LUMINIST: LUng Cancer Molecular Insights Non Interventional Study (LUMINIST)
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|ClinicalTrials.gov Identifier: NCT02300831|
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : July 14, 2017
|Condition or disease||Intervention/treatment|
|NSCLC||Other: Data Collection|
|Study Type :||Observational|
|Actual Enrollment :||770 participants|
|Official Title:||LUMINIST: LUng Cancer Molecular Insights Non Interventional Study|
|Actual Study Start Date :||December 1, 2014|
|Actual Primary Completion Date :||June 30, 2016|
|Actual Study Completion Date :||June 30, 2016|
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: Data Collection
Non interventional prospective data collection
Other Name: Advanced second line patients
- Overall survival (OS) [ Time Frame: Up to 34 months ]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.
- Progression Free survival (PFS) [ Time Frame: Up to 34 months ]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).
- Time to progression (TTP) [ Time Frame: Up to 34 months ]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.
- Duration of response (DOR) (complete or partial) [ Time Frame: Up to 34 months ]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.
- Complete response to treatment [ Time Frame: Up to 34 months ]The complete response to treatment will be calculated as the percentage of patients per line of therapy having a complete response.
- Healthcare resource utilisation (HRU) [ Time Frame: Up to 34 months ]The number of hospitalisations, emergency room and outpatient visits, and the proportion of patients with a caregiver will be estimated.
- Patients' characteristics [ Time Frame: Up to 34 months ]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.
- Overall Survival, Progression Free Survival, Time to Disease Progression, Duration of Response, Overall Response Rate and Healthcare Resource Utilisation [ Time Frame: Up to 34 months ]The main outcomes will be stratified on biomarkers if interest and line of therapy
- Prevalence of emerging biomarkers [ Time Frame: Up to 34 months ]Prevalence of each biomarker will be calculated as the percentage of patients presenting a mutation/alteration/amplification
- Treatment patterns among emerging biomarkers [ Time Frame: Up to 34 months ]Treatments will be described by biomarkers to identify any emerging pattern.
- Risk factors for non-response or resistance to standards of care [ Time Frame: Up to 34 months ]Regression model will be used to estimate risk factors for non-response or resistance to standards of care, notably known and emerging biomarkers.
Biospecimen Retention: None Retained
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300831
|Study Chair:||Gabriella Mariani, MD||AstraZeneca UK, MSD|