Clinical trial NCT02300831: LUMINIST: LUng Cancer Molecular Insights Non Interventional Study
Official title: LUMINIST: LUng Cancer Molecular Insights Non Interventional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NSCLC
Keywords: NSCLC
Lung Cancer
SELECT-1
SELECT-2
selumetinib
biomarker
NIS
Observational study
Disease registry
Clinical Outcomes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2014-11-25
Enrollment: 770
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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)

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 34 months
Secondary outcomes:
measure: Progression Free survival (PFS)
timeFrame: Up to 34 months
measure: Time to progression (TTP)
timeFrame: Up to 34 months
measure: Duration of response (DOR) (complete or partial)
timeFrame: Up to 34 months
measure: Complete response to treatment
timeFrame: Up to 34 months
measure: Healthcare resource utilisation (HRU)
timeFrame: Up to 34 months
measure: Patients' characteristics
timeFrame: Up to 34 months
Other outcomes:
measure: Overall Survival, Progression Free Survival, Time to Disease Progression, Duration of Response, Overall Response Rate and Healthcare Resource Utilisation
timeFrame: Up to 34 months
measure: Prevalence of emerging biomarkers
timeFrame: Up to 34 months
measure: Treatment patterns among emerging biomarkers
timeFrame: Up to 34 months
measure: Risk factors for non-response or resistance to standards of care
timeFrame: Up to 34 months
Locations:
city: Camperdown
country: Australia
facility: Research Site
city: Darlinghurst
country: Australia
facility: Research Site
city: Kurralta Park
country: Australia
facility: Research Site
city: Wendouree
country: Australia
facility: Research Site
city: Salzburg
country: Austria
facility: Research Site
city: Bruxelles
country: Belgium
facility: Research Site
city: Roeselare
country: Belgium
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Vratsa
country: Bulgaria
facility: Research Site
city: Edmonton
country: Canada
facility: Research Site
city: Montreal
country: Canada
facility: Research Site
city: Oshawa
country: Canada
facility: Research Site
city: Regina
country: Canada
facility: Research Site
city: Saskatoon
country: Canada
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Brest Cedex
country: France
facility: Research Site
city: Bad Berka
country: Germany
facility: Research Site
city: Grosshansdorf
country: Germany
facility: Research Site
city: Halle-Saale
country: Germany
facility: Research Site
city: Homburg / Saar
country: Germany
facility: Research Site
city: Koeln
country: Germany
facility: Research Site
city: Loewenstein
country: Germany
facility: Research Site
city: Moers
country: Germany
facility: Research Site
city: Muenchen
country: Germany
facility: Research Site
city: Ulm
country: Germany
facility: Research Site
city: Wuerzburg
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Edeleny
country: Hungary
facility: Research Site
city: Kaposvar
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Beer Sheva
country: Israel
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Kfar-Saba
country: Israel
facility: Research Site
city: Ramat-Gan
country: Israel
facility: Research Site
city: Tel Aviv
country: Israel
facility: Research Site
city: Bari
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Livorno
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Orbassano
country: Italy
facility: Research Site
city: Parma
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: 's Hertogenbosch
country: Netherlands
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Bergen op Zoom
country: Netherlands
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Sucha Beskidzka
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Amadora-Lisbon
country: Portugal
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Santa Maria da Feira
country: Portugal
facility: Research Site
city: Cluj-Napoca
country: Romania
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Volgograd
country: Russian Federation
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Vigo
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Linkoping
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Erzurum
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Manisa
country: Turkey
facility: Research Site
city: Dnipropetrovsk
country: Ukraine
facility: Research Site
city: Donetsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kryvyi Rih, Dnipropetrovsk Region
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Sumy
country: Ukraine
facility: Research Site
city: Uzhgorod
country: Ukraine
facility: Research Site
city: Aberdeen
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Wolverhampton
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca UK, MSD
name: Gabriella Mariani, MD
role: STUDY_CHAIR
References: