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Completed

NCT Number: NCT02300831

LUMINIST: LUng Cancer Molecular Insights Non Interventional Study

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.

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Key information

Conditions

NSCLC Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Camperdown, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Data Collection

Other

Non interventional prospective data collection

Other names: Advanced second line patients

Primary outcomes

  1. 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

  1. Progression Free survival (PFS)

    Time frame: 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).

  2. Time to progression (TTP)

    Time frame: 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.

  3. Duration of response (DOR) (complete or partial)

    Time frame: 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.

  4. Complete response to treatment

    Time frame: 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.

  5. Healthcare resource utilisation (HRU)

    Time frame: Up to 34 months

    The number of hospitalisations, emergency room and outpatient visits, and the proportion of patients with a caregiver will be estimated.

  6. Patients' characteristics

    Time frame: 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.

Other outcomes

  1. Overall Survival, Progression Free Survival, Time to Disease Progression, Duration of Response, Overall Response Rate and Healthcare Resource Utilisation

    Time frame: Up to 34 months

    The main outcomes will be stratified on biomarkers if interest and line of therapy

  2. Prevalence of emerging biomarkers

    Time frame: Up to 34 months

    Prevalence of each biomarker will be calculated as the percentage of patients presenting a mutation/alteration/amplification

  3. Treatment patterns among emerging biomarkers

    Time frame: Up to 34 months

    Treatments will be described by biomarkers to identify any emerging pattern.

  4. Risk factors for non-response or resistance to standards of care

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Quintiles, Inc.

Registry information

Acronym: LUMINIST

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 25, 2014
Registry last updated
Jul 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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