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.
Study Type
OBSERVATIONAL
Enrollment
770
Non interventional prospective data collection
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
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Research Site
Camperdown, Australia
Research Site
Darlinghurst, Australia
Research Site
Kurralta Park, Australia
Research Site
Wendouree, Australia
Research Site
Salzburg, Austria
Research Site
Brussels, Belgium
Research Site
Roeselare, Belgium
Research Site
Sofia, Bulgaria
Research Site
Vratsa, Bulgaria
Research Site
Edmonton, Canada
...and 75 more locations
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