EGFR Mutated Non-small Cell Lung Cancer PatientsCa_PulmonNCT01795352
Retrospective Study in a NSCLC M+ p
An observational study of EGFR Mutated Non-small Cell Lung Cancer Patients, run by AstraZeneca at 12 sites in Spain.
Trial summary
This is a national, multicentre, non-interventional, retrospective study to be carried out in the oncology settings of approximately 15-20 Spanish hospitals. At each participant hospital, all patients recently diagnosed with advanced EGFR mutated NSCLC (both newly or with recurrent disease , without previous treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR Mutated Non-small Cell Lung Cancer Patients
- How many people
- 187 participants
- Where
- 12 sitesSpain
- Study dates
- Mar 2013to Oct 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients recently diagnosed with advanced EGFR mutated NSCLC (both newly or with recurrent disease , without previous treatment for metastatic disease) from April 2010 to December 2011 will be included as study population.
Who may be able to join
- Histologically or cytologically confirmed newly locally advanced or metastatic NSCLC (stage IIIB/IV)
- Confirmed EGFR mutation by a validated test
- Availability of medical record
Who cannot join
- Participating on a blinded randomized clinical trial at any time during the study period
- Pregnant women (due to they do not reflect daily clinical practice)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
Research Site
Barcelona, Barcelona
Research Site
Córdoba, Cordoba
Research Site
Donostia / San Sebastian, Donostia
Research Site
Granada, Granada
Research Site
León, Leon
Research Site
Madrid, Madrid
Research Site
Málaga, Malaga
Research Site
Navarra, Navarre
Research Site
Seville, Sevilla
Research Site
Toledo, Toledo
Research Site
Valencia, Valencia
Research Site
Zaragoza, Zaragoza
About this study
Official title: Observational Retrospective Study to Describe the Management of Advanced or Metastatic EGFR (Epidermal Growth Factor Receptor) Mutated Non-small Cell Lung Cancer Patients in Spain
This is a national, multicentre, non-interventional, retrospective study to be carried out in the oncology settings of approximately 15-20 Spanish hospitals.
At each participant hospital, all patients recently diagnosed with advanced EGFR mutated NSCLC (both newly or with recurrent disease , without previous treatment for metastatic disease) from April 2010 to December 2011 will be included as study population. Information about the follow-up of the patients during a minimum of 12 months after diagnosis will be collected.
Read the detailed description
Observational retrospective study to describe the management of advanced or metastatic EGFR mutated non-small cell lung cancer patients in Spain
- Keywords
- EGFR,, lung cancer,, mutated
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of management patterns (clinical and diagnostic) of advanced/metastatic EGFR M+ NSCLC patients in Spain.
Measured: 32 months
Secondary outcomes (6)
Description of use of resources related with the management of advanced/metastatic EGFR M+ NSCLC patients in Spain.
Measured: 32 months
Evaluation of overall response rate (ORR).
Measured: 32 months
Evaluation of disease control rate (DCR).
Measured: 32 months
Evaluation of progression free survival (PFS: median PFS and 1 year PFS rate).
Measured: 32 months
Evaluation of overall survival (OS: median OS and 1 year OS rate).
Measured: 32 months
Description of clinical outcome data in all EGFR M+ patients by regimen, type of EGFR TK mutation, line of therapy and other relevant demographics or clinic pathologic characteristics.
TK- Tyrosine Kinase
Measured: 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Mutated Non-small Cell Lung Cancer PatientsStudies 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
- Time perspective
- Retrospective
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795352
- Sponsor's protocol ID
- NIS-OES-XXX-2012/1
- Acronym
- Ca_Pulmon
- Status last verified
- Oct 2013
- First submitted
- 18 Feb 2013
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Retrospective Study to Describe the Management of Advanced or Metastatic EGFR (Epidermal Growth Factor Receptor) Mutated Non-small Cell Lung Cancer Patients in Spain
- ClinicalTrials.gov ID
- NCT01795352
- Acronym / sponsor ID
- Ca_Pulmon / NIS-OES-XXX-2012/1
- Keywords
- EGFR,, lung cancer,, mutated
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 20 Feb 2013 (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.
This is a national, multicentre, non-interventional, retrospective study to be carried out in the oncology settings of approximately 15-20 Spanish hospitals.
At each participant hospital, all patients recently diagnosed with advanced EGFR mutated NSCLC (both newly or with recurrent disease , without previous treatment for metastatic disease) from April 2010 to December 2011 will be included as study population. Information about the follow-up of the patients during a minimum of 12 months after diagnosis will be collected.
Detailed description
Observational retrospective study to describe the management of advanced or metastatic EGFR mutated non-small cell lung cancer patients in Spain
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients recently diagnosed with advanced EGFR mutated NSCLC (both newly or with recurrent disease , without previous treatment for metastatic disease) from April 2010 to December 2011 will be included as study population.
Key inclusion criteria (3 listed)
- Histologically or cytologically confirmed newly locally advanced or metastatic NSCLC (stage IIIB/IV)
- Confirmed EGFR mutation by a validated test
- Availability of medical record
Key exclusion criteria (2 listed)
- Participating on a blinded randomized clinical trial at any time during the study period
- Pregnant women (due to they do not reflect daily clinical practice)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of management patterns (clinical and diagnostic) of advanced/metastatic EGFR M+ NSCLC patients in Spain.
Time frame: 32 months
6 secondary outcomes
Description of use of resources related with the management of advanced/metastatic EGFR M+ NSCLC patients in Spain.
Time frame: 32 months
Evaluation of overall response rate (ORR).
Time frame: 32 months
Evaluation of disease control rate (DCR).
Time frame: 32 months
Evaluation of progression free survival (PFS: median PFS and 1 year PFS rate).
Time frame: 32 months
Evaluation of overall survival (OS: median OS and 1 year OS rate).
Time frame: 32 months
Description of clinical outcome data in all EGFR M+ patients by regimen, type of EGFR TK mutation, line of therapy and other relevant demographics or clinic pathologic characteristics.
Time frame: 32 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 30 Oct 2013.
Related trials for EGFR Mutated Non-small Cell Lung Cancer Patients
RecruitingPhase 1/2
Phase I/II Study of PLB1004 Combined With Platinum-based Doublet Chemotherapy in Patients With EGFR Mutation-positive
NSCLC (Non-small Cell Lung Cancer)
RecruitingPhase 2
A Study of Stereotactic Radiosurgery (SRS) and Standard Treatment in People With Lung Cancer That Has Spread to the Brain
Non Small Cell Lung Cancer Metastatic
RecruitingPhase 4
An Open-label, Single-arm Study of Prophylaxis for Datopotamab Deruxtecan (Dato-DXd) -Related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-small Cell Lung Cancer.
Stomatitis
Not yet recruitingPhase 4
A Clinical Study Comparing the Efficacy and Safety of Befotertinib Versus Icotinib in Patients With Previously Untreated EGFR-sensitive Mutation-positive Non-small Cell Lung Cancer With ECOG Score ≥2
Locally Advanced or Metastatic Non-small Cell Lung Cancer With Previously Untreated EGFR-sensitive Mutations and ECOG Performance Status Score ≥2
Not yet recruitingPhase 3
ASKC202 Plus Limertinib as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC
EGFR Activating Mutation, Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of EGFR Mutated Non-small Cell Lung Cancer Patients, run by AstraZeneca at 12 sites in Spain.
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 3 inclusion and 2 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 30 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. 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?
Description of management patterns (clinical and diagnostic) of advanced/metastatic EGFR M+ NSCLC patients in Spain. (time frame: 32 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 30 Oct 2013.