LUMINIST: LUng Cancer Molecular Insights Non Interventional Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 770
- Locations
- 1
- Primary Endpoint
- Overall survival (OS)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Involved in the planning and/or conduct of this study (applies to both AZ staff and/or staff at the study site)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Progression Free survival (PFS)(Up to 34 months)
- Time to progression (TTP)(Up to 34 months)
- Patients' characteristics(Up to 34 months)
- Duration of response (DOR) (complete or partial)(Up to 34 months)
- Complete response to treatment(Up to 34 months)
- Healthcare resource utilisation (HRU)(Up to 34 months)