LUMINIST: LUng Cancer Molecular Insights Non Interventional Study

NCT02300831 | Completed

• 1 other identifier: D1532R00004
• Study Type: observational
• Target: 770
• Locations: 22 countries
• Sites: 84

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.

Conditions

NSCLC

Keywords

NSCLC; Lung Cancer; SELECT-1; SELECT-2; selumetinib; biomarker; NIS; Observational study; Disease registry; Clinical Outcomes

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  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 Outcomes (6)

• Progression Free survival (PFS)

  Up to 34 months

• Time to progression (TTP)

  Up to 34 months

• Duration of response (DOR) (complete or partial)

  Up to 34 months

• Complete response to treatment

  Up to 34 months

• Healthcare resource utilisation (HRU)

  Up to 34 months

Other Outcomes (4)

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

  Up to 34 months

• Prevalence of emerging biomarkers

  Up to 34 months

• Treatment patterns among emerging biomarkers

  Up to 34 months

Study Arms (1)

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

Interventions

Data Collection OTHER

Non interventional prospective data collection

Also known as: Advanced second line patients

NSCLC

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \. Involved in the planning and/or conduct of this study (applies to both AZ staff and/or staff at the study site)

Sponsors & Collaborators

• AstraZeneca: lead
• Quintiles, Inc.: collaborator

Study Sites (85)

Research Site

Camperdown, Australia

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Darlinghurst, Australia

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Kurralta Park, Australia

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Wendouree, Australia

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Salzburg, Austria

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Brussels, Belgium

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Roeselare, Belgium

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Sofia, Bulgaria

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Vratsa, Bulgaria

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Edmonton, Canada

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Montreal, Canada

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Oshawa, Canada

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Regina, Canada

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Saskatoon, Canada

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Santiago, Chile

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Brest, France

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Bad Berka, Germany

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Cologne, Germany

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Großhansdorf, Germany

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Halle, Germany

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Homburg / Saar, Germany

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Löwenstein, Germany

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Moers, Germany

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München, Germany

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Ulm, Germany

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Würzburg, Germany

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Budapest, Hungary

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Edelény, Hungary

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Kaposvár, Hungary

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Miskolc, Hungary

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Beersheba, Israel

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Haifa, Israel

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Kfar Saba, Israel

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Ramat Gan, Israel

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Tel Aviv, Israel

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Bari, Italy

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Genova, Italy

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Livorno, Italy

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Napoli, Italy

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Orbassano, Italy

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Parma, Italy

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Roma, Italy

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Monterrey, Mexico

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's-Hertogenbosch, Netherlands

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Amsterdam, Netherlands

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Bergen op Zoom, Netherlands

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Lima, Peru

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Bydgoszcz, Poland

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Gdansk, Poland

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Sucha Beskidzka, Poland

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Szczecin, Poland

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Warsaw, Poland

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Amadora-Lisbon, Portugal

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Coimbra, Portugal

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Lisbon, Portugal

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Porto, Portugal

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Santa Maria da Feira, Portugal

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Cluj-Napoca, Romania

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Chelyabinsk, Russia

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Moscow, Russia

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Saint Petersburg, Russia

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Volgograd, Russia

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Madrid, Spain

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Málaga, Spain

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Seville, Spain

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Vigo, Spain

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Zaragoza, Spain

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Linköping, Sweden

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Uppsala, Sweden

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Ankara, Turkey (Türkiye)

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Erzurum, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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Manisa, Turkey (Türkiye)

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Dnipropetrovsk, Ukraine

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Donetsk, Ukraine

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Kharkiv, Ukraine

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Kryvyi Rih, Dnipropetrovsk Region, Ukraine

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Kyiv, Ukraine

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Sumy, Ukraine

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Uzhhorod, Ukraine

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Aberdeen, United Kingdom

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Manchester, United Kingdom

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Nottingham, United Kingdom

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Wolverhampton, United Kingdom

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Related Links

• D1532R00004\_CSR\_Synopsis

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.

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Data Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Gabriella Mariani, MD

  AstraZeneca UK, MSD

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: November 25, 2014
• Study Start: December 1, 2014
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: July 14, 2017

Record last verified: 2017-07

Locations

ME (1); PL (5); IL (5); RU (4); CA (5); ES (5); BE (2); IT (7); TU (5); UA (7); AU (4); HU (4); PT (5); PE (1); RO (1); BU (2); GB (4); SE (2); DE (10); NL (3); FR (1); CL (1)