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

July 12, 2017 updated by: AstraZeneca
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

770

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Camperdown, Australia
        • Research Site
      • Darlinghurst, Australia
        • Research Site
      • Kurralta Park, Australia
        • Research Site
      • Wendouree, Australia
        • Research Site
  • Austria
      • Salzburg, Austria
        • Research Site
  • Belgium
      • Bruxelles, Belgium
        • Research Site
      • Roeselare, Belgium
        • Research Site
  • Bulgaria
      • Sofia, Bulgaria
        • Research Site
      • Vratsa, Bulgaria
        • Research Site
  • Canada
      • Edmonton, Canada
        • Research Site
      • Montreal, Canada
        • Research Site
      • Oshawa, Canada
        • Research Site
      • Regina, Canada
        • Research Site
      • Saskatoon, Canada
        • Research Site
  • Chile
      • Santiago, Chile
        • Research Site
  • France
      • Brest Cedex, France
        • Research Site
  • Germany
      • Bad Berka, Germany
        • Research Site
      • Grosshansdorf, Germany
        • Research Site
      • Halle-Saale, Germany
        • Research Site
      • Homburg / Saar, Germany
        • Research Site
      • Koeln, Germany
        • Research Site
      • Loewenstein, Germany
        • Research Site
      • Moers, Germany
        • Research Site
      • Muenchen, Germany
        • Research Site
      • Ulm, Germany
        • Research Site
      • Wuerzburg, Germany
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Edeleny, Hungary
        • Research Site
      • Kaposvar, Hungary
        • Research Site
      • Miskolc, Hungary
        • Research Site
  • Israel
      • Beer Sheva, Israel
        • Research Site
      • Haifa, Israel
        • Research Site
      • Kfar-Saba, Israel
        • Research Site
      • Ramat-Gan, Israel
        • Research Site
      • Tel Aviv, Israel
        • Research Site
  • Italy
      • Bari, Italy
        • Research Site
      • Genova, Italy
        • Research Site
      • Livorno, Italy
        • Research Site
      • Napoli, Italy
        • Research Site
      • Orbassano, Italy
        • Research Site
      • Parma, Italy
        • Research Site
      • Roma, Italy
        • Research Site
  • Mexico
      • Monterrey, Mexico
        • Research Site
  • Netherlands
      • 's Hertogenbosch, Netherlands
        • Research Site
      • Amsterdam, Netherlands
        • Research Site
      • Bergen op Zoom, Netherlands
        • Research Site
  • Peru
      • Lima, Peru
        • Research Site
  • Poland
      • Bydgoszcz, Poland
        • Research Site
      • Gdansk, Poland
        • Research Site
      • Sucha Beskidzka, Poland
        • Research Site
      • Szczecin, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
  • Portugal
      • Amadora-Lisbon, Portugal
        • Research Site
      • Coimbra, Portugal
        • Research Site
      • Lisboa, Portugal
        • Research Site
      • Porto, Portugal
        • Research Site
      • Santa Maria da Feira, Portugal
        • Research Site
  • Romania
      • Cluj-Napoca, Romania
        • Research Site
  • Russian Federation
      • Chelyabinsk, Russian Federation
        • Research Site
      • Moscow, Russian Federation
        • Research Site
      • Saint-Petersburg, Russian Federation
        • Research Site
      • St. Petersburg, Russian Federation
        • Research Site
      • Volgograd, Russian Federation
        • Research Site
  • Spain
      • Madrid, Spain
        • Research Site
      • Malaga, Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
      • Vigo, Spain
        • Research Site
      • Zaragoza, Spain
        • Research Site
  • Sweden
      • Linkoping, Sweden
        • Research Site
      • Uppsala, Sweden
        • Research Site
  • Turkey
      • Ankara, Turkey
        • Research Site
      • Erzurum, Turkey
        • Research Site
      • Istanbul, Turkey
        • Research Site
      • Izmir, Turkey
        • Research Site
      • Manisa, Turkey
        • Research Site
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • Research Site
      • Donetsk, Ukraine
        • Research Site
      • Kharkiv, Ukraine
        • Research Site
      • Kryvyi Rih, Dnipropetrovsk Region, Ukraine
        • Research Site
      • Kyiv, Ukraine
        • Research Site
      • Sumy, Ukraine
        • Research Site
      • Uzhgorod, Ukraine
        • Research Site
  • United Kingdom
      • Aberdeen, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site
      • Nottingham, United Kingdom
        • Research Site
      • Wolverhampton, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • Advanced second line patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 34 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Up to 34 months
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.
Up to 34 months
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.
Up to 34 months
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.
Up to 34 months
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.
Up to 34 months
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.
Up to 34 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 34 months
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
Up to 34 months
Treatment patterns among emerging biomarkers
Time Frame: Up to 34 months
Treatments will be described by biomarkers to identify any emerging pattern.
Up to 34 months
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.
Up to 34 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Quintiles, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

June 30, 2016

Study Completion (Actual)

June 30, 2016

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

November 21, 2014

First Posted (Estimate)

November 25, 2014

Study Record Updates

Last Update Posted (Actual)

July 14, 2017

Last Update Submitted That Met QC Criteria

July 12, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1532R00004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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