LUMINIST: LUng Cancer Molecular Insights Non Interventional Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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LUMINIST: LUng Cancer Molecular Insights Non Interventional Study

Conditions
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NSCLC

Intervention / Treatment
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* Other: Data Collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent from the patient or next-of-kin for deceased patient at study entry, where this is mandated by local regulations Female and male adults (according to each country regulations for age of majority) Patients who are not eligible or choose not to enter selumetinib SELECT-1 or SELECT-2 trials Patients with confirmed histological diagnosis of NSCLC 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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NSCLC<br>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<br>* Non interventional prospective data collection<br>* Other names: Advanced second line patients;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 34 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | 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. | 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. | 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. | Up to 34 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, Lung Cancer, SELECT-1, SELECT-2, selumetinib, biomarker, NIS, Observational study, Disease registry, Clinical Outcomes