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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02300831




Registration number
NCT02300831
Ethics application status
Date submitted
18/11/2014
Date registered
25/11/2014
Date last updated
14/07/2017

Titles & IDs
Public title
LUMINIST: LUng Cancer Molecular Insights Non Interventional Study
Scientific title
LUMINIST: LUng Cancer Molecular Insights Non Interventional Study
Secondary ID [1] 0 0
D1532R00004
Universal Trial Number (UTN)
Trial acronym
LUMINIST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NSCLC 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Data Collection

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 interventions: Data Collection
Non interventional prospective data collection

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Up to 34 months
Secondary outcome [1] 0 0
Progression Free survival (PFS) - 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).
Timepoint [1] 0 0
Up to 34 months
Secondary outcome [2] 0 0
Time to progression (TTP) - 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.
Timepoint [2] 0 0
Up to 34 months
Secondary outcome [3] 0 0
Duration of response (DOR) (complete or partial) - 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.
Timepoint [3] 0 0
Up to 34 months
Secondary outcome [4] 0 0
Complete response to treatment - The complete response to treatment will be calculated as the percentage of patients per line of therapy having a complete response.
Timepoint [4] 0 0
Up to 34 months
Secondary outcome [5] 0 0
Healthcare resource utilisation (HRU) - The number of hospitalisations, emergency room and outpatient visits, and the proportion of patients with a caregiver will be estimated.
Timepoint [5] 0 0
Up to 34 months
Secondary outcome [6] 0 0
Patients' characteristics - 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.
Timepoint [6] 0 0
Up to 34 months

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Darlinghurst
Recruitment hospital [3] 0 0
Research Site - Kurralta Park
Recruitment hospital [4] 0 0
Research Site - Wendouree
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
- Kurralta Park
Recruitment postcode(s) [4] 0 0
- Wendouree
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Salzburg
Country [2] 0 0
Belgium
State/province [2] 0 0
Bruxelles
Country [3] 0 0
Belgium
State/province [3] 0 0
Roeselare
Country [4] 0 0
Bulgaria
State/province [4] 0 0
Sofia
Country [5] 0 0
Bulgaria
State/province [5] 0 0
Vratsa
Country [6] 0 0
Canada
State/province [6] 0 0
Edmonton
Country [7] 0 0
Canada
State/province [7] 0 0
Montreal
Country [8] 0 0
Canada
State/province [8] 0 0
Oshawa
Country [9] 0 0
Canada
State/province [9] 0 0
Regina
Country [10] 0 0
Canada
State/province [10] 0 0
Saskatoon
Country [11] 0 0
Chile
State/province [11] 0 0
Santiago
Country [12] 0 0
France
State/province [12] 0 0
Brest Cedex
Country [13] 0 0
Germany
State/province [13] 0 0
Bad Berka
Country [14] 0 0
Germany
State/province [14] 0 0
Grosshansdorf
Country [15] 0 0
Germany
State/province [15] 0 0
Halle-Saale
Country [16] 0 0
Germany
State/province [16] 0 0
Homburg / Saar
Country [17] 0 0
Germany
State/province [17] 0 0
Koeln
Country [18] 0 0
Germany
State/province [18] 0 0
Loewenstein
Country [19] 0 0
Germany
State/province [19] 0 0
Moers
Country [20] 0 0
Germany
State/province [20] 0 0
Muenchen
Country [21] 0 0
Germany
State/province [21] 0 0
Ulm
Country [22] 0 0
Germany
State/province [22] 0 0
Wuerzburg
Country [23] 0 0
Hungary
State/province [23] 0 0
Budapest
Country [24] 0 0
Hungary
State/province [24] 0 0
Edeleny
Country [25] 0 0
Hungary
State/province [25] 0 0
Kaposvar
Country [26] 0 0
Hungary
State/province [26] 0 0
Miskolc
Country [27] 0 0
Israel
State/province [27] 0 0
Beer Sheva
Country [28] 0 0
Israel
State/province [28] 0 0
Haifa
Country [29] 0 0
Israel
State/province [29] 0 0
Kfar-Saba
Country [30] 0 0
Israel
State/province [30] 0 0
Ramat-Gan
Country [31] 0 0
Israel
State/province [31] 0 0
Tel Aviv
Country [32] 0 0
Italy
State/province [32] 0 0
Bari
Country [33] 0 0
Italy
State/province [33] 0 0
Genova
Country [34] 0 0
Italy
State/province [34] 0 0
Livorno
Country [35] 0 0
Italy
State/province [35] 0 0
Napoli
Country [36] 0 0
Italy
State/province [36] 0 0
Orbassano
Country [37] 0 0
Italy
State/province [37] 0 0
Parma
Country [38] 0 0
Italy
State/province [38] 0 0
Roma
Country [39] 0 0
Mexico
State/province [39] 0 0
Monterrey
Country [40] 0 0
Netherlands
State/province [40] 0 0
's Hertogenbosch
Country [41] 0 0
Netherlands
State/province [41] 0 0
Amsterdam
Country [42] 0 0
Netherlands
State/province [42] 0 0
Bergen op Zoom
Country [43] 0 0
Peru
State/province [43] 0 0
Lima
Country [44] 0 0
Poland
State/province [44] 0 0
Bydgoszcz
Country [45] 0 0
Poland
State/province [45] 0 0
Gdansk
Country [46] 0 0
Poland
State/province [46] 0 0
Sucha Beskidzka
Country [47] 0 0
Poland
State/province [47] 0 0
Szczecin
Country [48] 0 0
Poland
State/province [48] 0 0
Warszawa
Country [49] 0 0
Portugal
State/province [49] 0 0
Amadora-Lisbon
Country [50] 0 0
Portugal
State/province [50] 0 0
Coimbra
Country [51] 0 0
Portugal
State/province [51] 0 0
Lisboa
Country [52] 0 0
Portugal
State/province [52] 0 0
Porto
Country [53] 0 0
Portugal
State/province [53] 0 0
Santa Maria da Feira
Country [54] 0 0
Romania
State/province [54] 0 0
Cluj-Napoca
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Chelyabinsk
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Moscow
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Saint-Petersburg
Country [58] 0 0
Russian Federation
State/province [58] 0 0
St. Petersburg
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Volgograd
Country [60] 0 0
Spain
State/province [60] 0 0
Madrid
Country [61] 0 0
Spain
State/province [61] 0 0
Malaga
Country [62] 0 0
Spain
State/province [62] 0 0
Sevilla
Country [63] 0 0
Spain
State/province [63] 0 0
Vigo
Country [64] 0 0
Spain
State/province [64] 0 0
Zaragoza
Country [65] 0 0
Sweden
State/province [65] 0 0
Linkoping
Country [66] 0 0
Sweden
State/province [66] 0 0
Uppsala
Country [67] 0 0
Turkey
State/province [67] 0 0
Ankara
Country [68] 0 0
Turkey
State/province [68] 0 0
Erzurum
Country [69] 0 0
Turkey
State/province [69] 0 0
Istanbul
Country [70] 0 0
Turkey
State/province [70] 0 0
Izmir
Country [71] 0 0
Turkey
State/province [71] 0 0
Manisa
Country [72] 0 0
Ukraine
State/province [72] 0 0
Dnipropetrovsk
Country [73] 0 0
Ukraine
State/province [73] 0 0
Donetsk
Country [74] 0 0
Ukraine
State/province [74] 0 0
Kharkiv
Country [75] 0 0
Ukraine
State/province [75] 0 0
Kryvyi Rih, Dnipropetrovsk Region
Country [76] 0 0
Ukraine
State/province [76] 0 0
Kyiv
Country [77] 0 0
Ukraine
State/province [77] 0 0
Sumy
Country [78] 0 0
Ukraine
State/province [78] 0 0
Uzhgorod
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Aberdeen
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Manchester
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Nottingham
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Quintiles, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02300831
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gabriella Mariani, MD
Address 0 0
AstraZeneca UK, MSD
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications