LUMINIST: LUng Cancer Molecular Insights Non Interventional Study

Completed

• Conditions: NSCLC
• Interventions: Other: Data Collection

• Registration Number: NCT02300831
• Lead Sponsor: AstraZeneca

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 Timeline

• Study First Submitted: 2014-11-18
• Study First Submitted QC: 2014-11-21
• Study First Posted: 2014-11-25
• Study Start: 2014-12-01
• Primary Completion: 2016-06-30
• Study Completion: 2016-06-30
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-12
• Last Update Posted: 2017-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 770

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NSCLC	Data Collection	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.
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.
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.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Wolverhampton, United Kingdom