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LUMINIST: LUng Cancer Molecular Insights Non Interventional Study (LUMINIST)

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ClinicalTrials.gov Identifier: NCT02300831
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : July 14, 2017
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
NSCLC Other: Data Collection

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.

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Study Type : Observational
Actual Enrollment : 770 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: LUMINIST: LUng Cancer Molecular Insights Non Interventional Study
Actual Study Start Date : December 1, 2014
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : June 30, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
NSCLC
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
Non interventional prospective data collection
Other Name: Advanced second line patients




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Biospecimen Retention:   None Retained
All samples used in the study are collected under the auspices of the SELECT 1 study screening. Luminist provides the clinical data to correlate the with sample results.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300831


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Sponsors and Collaborators
AstraZeneca
Quintiles, Inc.
Investigators
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Study Chair: Gabriella Mariani, MD AstraZeneca UK, MSD

Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02300831     History of Changes
Other Study ID Numbers: D1532R00004
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017

Keywords provided by AstraZeneca:
NSCLC
Lung Cancer
SELECT-1
SELECT-2
selumetinib
biomarker
NIS
Observational study
Disease registry
Clinical Outcomes

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases