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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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