NSCLCLUMINISTNCT02300831
LUMINIST: LUng Cancer Molecular Insights Non Interventional Study
An observational study of NSCLC, run by AstraZeneca at 85 sites in 23 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- NSCLC
- What is being tested?
- Data Collection
- How many people
- 770 participants
- Where
- 85 sitesin 23 countries
- Study dates
- 1 Dec 2014to 30 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 1. Involved in the planning and/or conduct of this study (applies to both AZ staff and/or staff at the study site)
Trial locations and contacts
85 sites in 23 countries.
85 sites in 23 countries
Germany10 sites
Research Site
Bad Berka
Research Site
Cologne
Research Site
Großhansdorf
Research Site
Halle
Research Site
Homburg / Saar
Research Site
Löwenstein
Research Site
Moers
Research Site
München
Research Site
Ulm
Research Site
Würzburg
Italy7 sites
Research Site
Bari
Research Site
Genova
Research Site
Livorno
Research Site
Naples
Research Site
Orbassano
Research Site
Parma
Research Site
Roma
Ukraine7 sites
Research Site
Dnipropetrovsk
Research Site
Donetsk
Research Site
Kharkiv
Research Site
Kryvyi Rih, Dnipropetrovsk Region
Research Site
Kyiv
Research Site
Sumy
Research Site
Uzhhorod
Canada5 sites
Research Site
Edmonton
Research Site
Montreal
Research Site
Oshawa
Research Site
Regina
Research Site
Saskatoon
Israel5 sites
Research Site
Beersheba
Research Site
Haifa
Research Site
Kfar Saba
Research Site
Ramat Gan
Research Site
Tel Aviv
Poland5 sites
Research Site
Bydgoszcz
Research Site
Gdansk
Research Site
Sucha Beskidzka
Research Site
Szczecin
Research Site
Warsaw
Portugal5 sites
Research Site
Amadora-Lisbon
Research Site
Coimbra
Research Site
Lisbon
Research Site
Porto
Research Site
Santa Maria da Feira
Spain5 sites
Research Site
Madrid
Research Site
Málaga
Research Site
Seville
Research Site
Vigo
Research Site
Zaragoza
Turkey (Türkiye)5 sites
Research Site
Ankara
Research Site
Erzurum
Research Site
Istanbul
Research Site
Izmir
Research Site
Manisa
Australia4 sites
Research Site
Camperdown
Research Site
Darlinghurst
Research Site
Kurralta Park
Research Site
Wendouree
Hungary4 sites
Research Site
Budapest
Research Site
Edelény
Research Site
Kaposvár
Research Site
Miskolc
Russia4 sites
Research Site
Chelyabinsk
Research Site
Moscow
Research Site
Saint Petersburg
Research Site
Volgograd
United Kingdom4 sites
Research Site
Aberdeen
Research Site
Manchester
Research Site
Nottingham
Research Site
Wolverhampton
Netherlands3 sites
Research Site
's-Hertogenbosch
Research Site
Amsterdam
Research Site
Bergen op Zoom
About this study
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.
Read the 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.
- Conditions
- NSCLC
- Being tested
- Data Collection
- Keywords
- NSCLC, Lung Cancer, SELECT-1, SELECT-2, selumetinib, biomarker, NIS, Observational study, Disease registry, Clinical Outcomes
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data CollectionOther
Also called Advanced second line patients
Non interventional prospective data collection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 34 months
Secondary outcomes (6)
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).
Measured: Up to 34 months
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.
Measured: Up to 34 months
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.
Measured: Up to 34 months
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.
Measured: Up to 34 months
Healthcare resource utilisation (HRU)
The number of hospitalisations, emergency room and outpatient visits, and the proportion of patients with a caregiver will be estimated.
Measured: Up to 34 months
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.
Measured: Up to 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study start1 Dec 2014
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 770 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Gabriella Mariani, MD, Study chair, AstraZeneca UK, MSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300831
- Sponsor's protocol ID
- D1532R00004
- Acronym
- LUMINIST
- Status last verified
- Jul 2017
- First submitted
- 18 Nov 2014
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUMINIST: LUng Cancer Molecular Insights Non Interventional Study
- ClinicalTrials.gov ID
- NCT02300831
- Acronym / sponsor ID
- LUMINIST / D1532R00004
- Conditions
- NSCLC
- Keywords
- NSCLC, Lung Cancer, SELECT-1, SELECT-2, selumetinib, biomarker, NIS, Observational study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 770 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 25 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSCLC | – | Other: Data CollectionThe 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Involved in the planning and/or conduct of this study (applies to both AZ staff and/or staff at the study site)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data CollectionAlso: Advanced second line patientsNon interventional prospective data collection | Other | NSCLC |
Primary outcome
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.
6 secondary outcomes
Progression Free survival (PFS)
Time frame: Up to 34 months
Time to progression (TTP)
Time frame: Up to 34 months
Duration of response (DOR) (complete or partial)
Time frame: Up to 34 months
Complete response to treatment
Time frame: Up to 34 months
Healthcare resource utilisation (HRU)
Time frame: Up to 34 months
Patients' characteristics
Time frame: Up to 34 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
- D1532R00004\_CSR\_SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriella Mariani, MD study chair
AstraZeneca UK, MSD
85 sites in 23 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by AstraZeneca at 85 sites in 23 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 sites in Germany, Italy, Ukraine, Canada, Israel and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: Up to 34 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2017.