Non-Squamous Non-Small Cell Lung CancerNCT01343914
An Observational Study on Patients With Non-Squamous NSCLC Who Reached A Long PFS After Avastin (Bevacizumab)-Based First-Line Therapy
An observational study of Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 33 sites in Spain.
Trial summary
This retrospective observational study will analyse demographic, clinical and treatment-related data of patients with non-squamous non-small cell lung cancer (NSCLC) who had reached >/= 9 months of progression-free survival after Avastin (bevacizumab)-based first-line therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Squamous Non-Small Cell Lung Cancer
- How many people
- 118 participants
- Where
- 33 sitesSpain
- Study dates
- Jun 2011to Dec 2011
- 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: Non squamous NSCLC patients treated with bevacizumab-based first line therapy and PFS >/= 9 months
Who may be able to join
- Adult patients, >/= 18 years of age
- Non-squamous non-small cell lung cancer (NSCLC) treated with first-line Avastin-based therapy
- Progression-free survival of >/= 9 months reached
Who cannot join
- N/A
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
Spain33 sites
Study site
Alcoy, Alicante, 03804
Study site
Alicante, Alicante, 3010
Study site
Almería, Almeria, 04009
Study site
Barcelona, Barcelona, 08028
Study site
Barcelona, Barcelona, 08041
Study site
Barcelona, Barcelona, 08916
Study site
Cáceres, Caceres, 10003
Study site
Elche, Alicante, 03203
Study site
Elda, Alicante, 03600
Study site
Jaén, Jaen, 23007
Study site
León, Leon, 24071
Study site
Lugo, Lugo, 27004
Study site
Madrid, Madrid, 28007
Study site
Madrid, Madrid, 28033
Study site
Madrid, Madrid, 28034
Study site
Madrid, Madrid, 28040
Study site
Madrid, Madrid, 28046
Study site
Madrid, Madrid, 28050
Study site
Madrid, Madrid, 28935
Study site
Málaga, Malaga, 29010
Study site
Manacor, Balearic Islands, 07500
Study site
Murcia, Murcia, 30008
Study site
Navarra, Navarre, 31008
Study site
Palma de Mallorca, Balearic Islands, 07012
Study site
Pontevedra, Pontevedra, 36002
Study site
San Sebastián de los Reyes, Guipuzcoa, 28702
Study site
Santiago de Compostela, La Coruña, 15706
Study site
Seville, Sevilla, 41013
Study site
Valencia, Valencia, 46015
Study site
Valencia, Valencia, 46017
Study site
Valencia, Valencia, 46026
Study site
Vigo, Pontevedra, 36312
Study site
Zaragoza, Zaragoza, 50009
About this study
Official title: Retrospective Study to Determinate the Clinical Phenotype of Patients With Non Squamous NSCLC Treated With First Line Bevacizumab-based Therapy That Reached a Long PFS
This retrospective observational study will analyse demographic, clinical and treatment-related data of patients with non-squamous non-small cell lung cancer (NSCLC) who had reached >/= 9 months of progression-free survival after Avastin (bevacizumab)-based first-line therapy. Data will be collected for approximately 9 months.
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (>9 months) according to clinical phenotype
Measured: approximately 9 months
Secondary outcomes (2)
Overall survival
Measured: approximately 9 months
Safety: Incidence of adverse events
Measured: approximately 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Squamous Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Retrospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343914
- Sponsor's protocol ID
- ML25494
- Status last verified
- Nov 2016
- First submitted
- 12 Apr 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study to Determinate the Clinical Phenotype of Patients With Non Squamous NSCLC Treated With First Line Bevacizumab-based Therapy That Reached a Long PFS
- ClinicalTrials.gov ID
- NCT01343914
- Acronym / sponsor ID
- ML25494
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 Apr 2011 (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 retrospective observational study will analyse demographic, clinical and treatment-related data of patients with non-squamous non-small cell lung cancer (NSCLC) who had reached >/= 9 months of progression-free survival after Avastin (bevacizumab)-based first-line therapy. Data will be collected for approximately 9 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non squamous NSCLC patients treated with bevacizumab-based first line therapy and PFS >/= 9 months
Key inclusion criteria (3 listed)
- Adult patients, >/= 18 years of age
- Non-squamous non-small cell lung cancer (NSCLC) treated with first-line Avastin-based therapy
- Progression-free survival of >/= 9 months reached
Key exclusion criteria (1 listed)
- N/A
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
Progression-free survival (>9 months) according to clinical phenotype
Time frame: approximately 9 months
2 secondary outcomes
Overall survival
Time frame: approximately 9 months
Safety: Incidence of adverse events
Time frame: approximately 9 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 2 Nov 2016.
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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.
Clinical Trials study director
Hoffmann-La Roche
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 33 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 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 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?
Progression-free survival (>9 months) according to clinical phenotype (time frame: approximately 9 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 2 Nov 2016.