NSCLC
Conditions
Keywords
NSCLC, Lung Cancer, SELECT-1, SELECT-2, selumetinib, biomarker, NIS, Observational study, Disease registry, Clinical Outcomes
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.
Detailed description
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.
Interventions
OTHERData Collection
Non interventional prospective data collection
Sponsors
Quintiles, Inc.
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients' characteristics | 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. |
| Time to progression (TTP) | 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) | 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 | 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) | Up to 34 months | The number of hospitalisations, emergency room and outpatient visits, and the proportion of patients with a caregiver will be estimated. |
| Progression Free survival (PFS) | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of emerging biomarkers | 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 | 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 | 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. |
| Overall Survival, Progression Free Survival, Time to Disease Progression, Duration of Response, Overall Response Rate and Healthcare Resource Utilisation | Up to 34 months | The main outcomes will be stratified on biomarkers if interest and line of therapy |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Chile, France, Germany, Hungary, Israel, Italy, Mexico, Netherlands, Peru, Poland, Portugal, Romania, Russia, Spain, Sweden, Turkey (Türkiye), Ukraine, United Kingdom
Outcome results
None listed