Non-Squamous Non-Small Cell Lung CancerNCT01488331
An Observational Study of Tarceva (Erlotinib) in Patients With Non-Small Cell Lung Cancer
An observational study of Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 92 sites in France.
Trial summary
This prospective, multi-center, observational study will assess the progression-free survival and safety of patients with locally advanced or metastatic non-small cell lung cancer treated with Tarceva (erlotinib) and not disease progressing after at least 9 months. Data will be collected for 24 months. 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
- 217 participants
- Where
- 92 sitesFrance
- Study dates
- Jun 2010to Nov 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: Adult patients with non-small cell lung cancer
Who may be able to join
- Adult patients, >/=18 years of age
- Diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC, stage III/IV)
- Treatment with Tarceva monotherapy and not progressing after at least 9 months at the date of study start
Who cannot join
- Not agreeing to be followed-up (for a maximum of 24 months)
Trial locations and contacts
92 sites in 1 country.
92 sites in 1 country
France92 sites
Study site
Abbeville, 80142
Study site
Agen, 47000
Study site
Aix-en-Provence, 13616
Study site
Aix-en-Provence, 13617
Study site
Ajaccio, 20176
Study site
Amiens, 80090
Study site
Angers, 49933
Study site
Annecy, 74000
Study site
Aubagne, 13400
Study site
Auxerre, 89000
Study site
Bastia, 20200
Study site
Bordeaux, 33077
Study site
Bourg-en-Bresse, 01012
Study site
Brest, 29200
Study site
Brest, 29240
Study site
Bron, 69677
Study site
Bry-sur-Marne, 94366
Study site
Caen, 14076
Study site
Cagnes-sur-Mer, 06805
Study site
Chalon-sur-Saône, 71100
Study site
Chambray-lès-Tours, 37175
Study site
Chaumont, 52014
Study site
Chauny, 02303
Study site
Cholet, 49325
Study site
Clamart, 92141
Study site
Clermont-Ferrand, 63003
Study site
Colmar, 68024
Study site
Compiègne, 60321
Study site
Coquelles, 62231
Study site
Cornebarrieu, 31700
Study site
Creil, 60109
Study site
Créteil, 94010
Study site
Dax, 40107
Study site
Dijon, 21079
Study site
Draguignan, 83007
Study site
Eaubonne, 95602
Study site
Fréjus, 83608
Study site
Gap, 05007
Study site
Gleizé, 69400
Study site
Helfaut, 62570
Study site
Hyères, 83400
Study site
La Chaussée-Saint-Victor, 41260
Study site
La Roche-sur-Yon, 85925
Study site
La Rochelle, 17019
Study site
La Source, 45100
Study site
La Tronche, 38700
Study site
Le Plessis-Robinson, 92350
Study site
Libourne, 33505
Study site
Limoges, 87042
Study site
Longjumeau, 91161
Study site
Lyon, 69275
Study site
Lyon, 69365
Study site
Meaux, 77104
Study site
Metz, 57000
Study site
Meudon, 92360
Study site
Montauban, 82013
Study site
Montpellier, 34070
Study site
Mulhouse, 68070
Study site
Nancy, 54100
Study site
Nantes, 44202
Study site
Nevers, 58033
Study site
Paris, 75230
Study site
Paris, 75571
Study site
Paris, 75908
Study site
Perpignan, 66012
Study site
Perpignan, 66046
Study site
Pierre-Bénite, 69495
Study site
Pontoise, 95300
Study site
Reims, 51056
Study site
Reims, 51057
Study site
Rennes, 35033
Study site
Rouen, 76000
Study site
Saint-Aubin-lès-Elbeuf, 76410
Study site
Saint-Avold, 57502
Study site
Saint-Brieuc, 22027
Study site
Saint-Jean, 31240
Study site
Saint-Priest-en-Jarez, 42271
Study site
Saint-Priest-en-Jarez, 42770
Study site
Saint-Quentin, 02321
Study site
Salon-de-Provence, 13300
Study site
Senlis, 60309
Study site
Strasbourg, 67010
Study site
Strasbourg, 67065
Study site
Strasbourg, 67091
Study site
Tarbes, 65000
Study site
Thionville, 57126
Study site
Toulon, 83041
Study site
Toulon, 83056
Study site
Toulouse, 31059
Study site
Tours, 37044
Study site
Vénissieux, 69200
Study site
Vichy, 3201
About this study
Official title: A Patient Cohort With Locally Advanced or Metastatic Non-small Cell Lung Cancer Treated With Tarceva (Erlotinib) Monotherapy and Not Progressing After at Least 9 Months
This prospective, multi-center, observational study will assess the progression-free survival and safety of patients with locally advanced or metastatic non-small cell lung cancer treated with Tarceva (erlotinib) and not disease progressing after at least 9 months. Data will be collected for 24 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
Measured: 24 months
Secondary outcomes (5)
Best treatment response
Measured: 24 months
Overall survival
Measured: 24 months
Safety (incidence of adverse events)
Measured: 24 months
Type of treatment response
Measured: 24 months
Treatment compliance of patient
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startJun 2010
- Primary completionNov 2013
- Study completionNov 2013
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
- Prospective
- Enrolment
- 217 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
- NCT01488331
- Sponsor's protocol ID
- ML22973
- Status last verified
- Nov 2016
- First submitted
- 6 Dec 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
- A Patient Cohort With Locally Advanced or Metastatic Non-small Cell Lung Cancer Treated With Tarceva (Erlotinib) Monotherapy and Not Progressing After at Least 9 Months
- ClinicalTrials.gov ID
- NCT01488331
- Acronym / sponsor ID
- ML22973
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 8 Dec 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 prospective, multi-center, observational study will assess the progression-free survival and safety of patients with locally advanced or metastatic non-small cell lung cancer treated with Tarceva (erlotinib) and not disease progressing after at least 9 months. Data will be collected for 24 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- 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
- Adult patients with non-small cell lung cancer
Key inclusion criteria (3 listed)
- Adult patients, >/=18 years of age
- Diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC, stage III/IV)
- Treatment with Tarceva monotherapy and not progressing after at least 9 months at the date of study start
Key exclusion criteria (1 listed)
- Not agreeing to be followed-up (for a maximum of 24 months)
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
Time frame: 24 months
5 secondary outcomes
Best treatment response
Time frame: 24 months
Overall survival
Time frame: 24 months
Safety (incidence of adverse events)
Time frame: 24 months
Type of treatment response
Time frame: 24 months
Treatment compliance of patient
Time frame: 24 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
92 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 92 sites in France.
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 92 sites in France. 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 (time frame: 24 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.