LUMINIST: LUng Cancer Molecular Insights Non Interventional Study

NSCLC Clinical Trial

— LUMINIST  

Official title:

LUMINIST: LUng Cancer Molecular Insights Non Interventional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02300831
• Other study ID #: D1532R00004
• Status: Completed
• Phase: N/A
• First received: November 18, 2014
• Last updated: July 12, 2017
• Start date: December 1, 2014
• Est. completion date: June 30, 2016

Study information

• Verified date: July 2017
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 770
• Est. completion date: June 30, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Lung Neoplasms
• NSCLC

Intervention

Other:
• Data Collection
Non interventional prospective data collection

Locations

Country	Name	City	State
Australia	Research Site	Camperdown
Australia	Research Site	Darlinghurst
Australia	Research Site	Kurralta Park
Australia	Research Site	Wendouree
Austria	Research Site	Salzburg
Belgium	Research Site	Bruxelles
Belgium	Research Site	Roeselare
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Vratsa
Canada	Research Site	Edmonton
Canada	Research Site	Montreal
Canada	Research Site	Oshawa
Canada	Research Site	Regina
Canada	Research Site	Saskatoon
Chile	Research Site	Santiago
France	Research Site	Brest Cedex
Germany	Research Site	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
Hungary	Research Site	Budapest
Hungary	Research Site	Edeleny
Hungary	Research Site	Kaposvar
Hungary	Research Site	Miskolc
Israel	Research Site	Beer Sheva
Israel	Research Site	Haifa
Israel	Research Site	Kfar-Saba
Israel	Research Site	Ramat-Gan
Israel	Research Site	Tel Aviv
Italy	Research Site	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
Mexico	Research Site	Monterrey
Netherlands	Research Site	's Hertogenbosch
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Bergen op Zoom
Peru	Research Site	Lima
Poland	Research Site	Bydgoszcz
Poland	Research Site	Gdansk
Poland	Research Site	Sucha Beskidzka
Poland	Research Site	Szczecin
Poland	Research Site	Warszawa
Portugal	Research Site	Amadora-Lisbon
Portugal	Research Site	Coimbra
Portugal	Research Site	Lisboa
Portugal	Research Site	Porto
Portugal	Research Site	Santa Maria da Feira
Romania	Research Site	Cluj-Napoca
Russian Federation	Research Site	Chelyabinsk
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	St. Petersburg
Russian Federation	Research Site	Volgograd
Spain	Research Site	Madrid
Spain	Research Site	Malaga
Spain	Research Site	Sevilla
Spain	Research Site	Vigo
Spain	Research Site	Zaragoza
Sweden	Research Site	Linkoping
Sweden	Research Site	Uppsala
Turkey	Research Site	Ankara
Turkey	Research Site	Erzurum
Turkey	Research Site	Istanbul
Turkey	Research Site	Izmir
Turkey	Research Site	Manisa
Ukraine	Research Site	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
United Kingdom	Research Site	Aberdeen
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Nottingham
United Kingdom	Research Site	Wolverhampton

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Quintiles, Inc.

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Chile,  France,  Germany,  Hungary,  Israel,  Italy,  Mexico,  Netherlands,  Peru,  Poland,  Portugal,  Romania,  Russian Federation,  Spain,  Sweden,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall Survival, Progression Free Survival, Time to Disease Progression, Duration of Response, Overall Response Rate and Healthcare Resource Utilisation	The main outcomes will be stratified on biomarkers if interest and line of therapy	Up to 34 months
Other	Prevalence of emerging biomarkers	Prevalence of each biomarker will be calculated as the percentage of patients presenting a mutation/alteration/amplification	Up to 34 months
Other	Treatment patterns among emerging biomarkers	Treatments will be described by biomarkers to identify any emerging pattern.	Up to 34 months
Other	Risk factors for non-response or resistance to standards of care	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
Primary	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	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).	Up to 34 months
Secondary	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.	Up to 34 months
Secondary	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.	Up to 34 months
Secondary	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.	Up to 34 months
Secondary	Healthcare resource utilisation (HRU)	The number of hospitalisations, emergency room and outpatient visits, and the proportion of patients with a caregiver will be estimated.	Up to 34 months
Secondary	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.	Up to 34 months

External Links

•   D1532R00004_CSR_Synopsis