An observational study in NSCLC, sponsored by AstraZeneca. Completed at 86 sites in 23 countries. Per ClinicalTrials.gov, last updated 2017-07-14.
Sponsored by AstraZeneca · Observational
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.
The LUMINIST study will enrol patients who are ineligible for the SELECT-1 (NCT01933932) or SELECT-2 (NCT01750281)RCTs. Within this NIS patients will be followed longitudinally for treatment information and outcomes. The final dataset will enable linkage at the individual patient level of the clinical information datasets collected within LUMINIST to the exploratory biomarker data generated from samples collected as part of SELECT-1 screening. This will enable the examination of various molecular markers in patients with v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type and some KRAS mutation positive (KRAS+) patients. The LUMINIST study aims to enable the investigation of various molecular segments in NSCLC, based on patient consent and where permitted by local legislation, some of which have not yet been discovered. The availability of a longitudinal dataset of clinical information linked to tumour samples will be a valuable tool to readily assess the clinical utility of potential new biomarkers. The determination of current standards of care and outcomes in future molecular segments of interest will provide valuable new insights to the scientific community.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 770 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
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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.
Exclusion Criteria:
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
Also known as: Advanced second line patients
Overall survival (OS)
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.
Time frame: Up to 34 months
Progression Free survival (PFS)
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 frame: Up to 34 months
Time to progression (TTP)
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.
Time frame: Up to 34 months
Duration of response (DOR) (complete or partial)
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.
Time frame: Up to 34 months
Complete response to treatment
The complete response to treatment will be calculated as the percentage of patients per line of therapy having a complete response.
Time frame: Up to 34 months
Healthcare resource utilisation (HRU)
The number of hospitalisations, emergency room and outpatient visits, and the proportion of patients with a caregiver will be estimated.
Time frame: Up to 34 months
Patients' characteristics
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.
Time frame: Up to 34 months
Overall Survival, Progression Free Survival, Time to Disease Progression, Duration of Response, Overall Response Rate and Healthcare Resource Utilisation
The main outcomes will be stratified on biomarkers if interest and line of therapy
Time frame: Up to 34 months
Prevalence of emerging biomarkers
Prevalence of each biomarker will be calculated as the percentage of patients presenting a mutation/alteration/amplification
Time frame: Up to 34 months
Treatment patterns among emerging biomarkers
Treatments will be described by biomarkers to identify any emerging pattern.
Time frame: Up to 34 months
Risk factors for non-response or resistance to standards of care
Regression model will be used to estimate risk factors for non-response or resistance to standards of care, notably known and emerging biomarkers.
Time frame: Up to 34 months
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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