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Non-Squamous Non-Small Cell Lung CancerNCT01333007

An Observational Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer

An observational study of Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 152 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This observational study will evaluate modality, efficacy and safety of Avastin (bevacizumab) as first-line treatment in combination with chemotherapy in patients with inoperable advanced, metastatic or recurrent non-squamous non-small cell lung cancer in clinical practice. 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
423 participants
Where
152 sitesFrance
Study dates
Jul 2010to May 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: Patients With Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer

Who may be able to join

  • Adult patients, >/= 18 years of age
  • Inoperable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC)
  • Treating physician's decision to initiate first-line Avastin treatment

Who cannot join

  • Participation in a clinical trial evaluating anti-cancer therapies

Trial locations and contacts

152 sites in 1 country.

152 sites in 1 country

France152 sites

  • Study site

    Abbeville, 80142

  • Study site

    Agen, 47000

  • Study site

    Aix-en-Provence, 13616

  • Study site

    Aix-en-Provence, 13617

  • Study site

    Alès, 30100

  • Study site

    Ambilly, 74100

  • Study site

    Amiens, 80090

  • Study site

    Amilly, 45200

  • Study site

    Angers, 49933

  • Study site

    Annecy, 74000

  • Study site

    Antibes, 06600

  • Study site

    Armentières, 59421

  • Study site

    Arras, 62022

  • Study site

    Aubenas, 07205

  • Study site

    Aulnay-sous-Bois, 93602

  • Study site

    Auxerre, 89000

  • Study site

    Bar-le-Duc, 55012

  • Study site

    Bastia, 20200

  • Study site

    Bastia, 20604

  • Study site

    Bayeux, 14401

  • Study site

    Bayonne, 64100

  • Study site

    Bayonne, 64109

  • Study site

    Besançon, 25030

  • Study site

    Beuvry, 62660

  • Study site

    Biarritz, 64204

  • Study site

    Bobigny, 93009

  • Study site

    Bois-Guillaume, 76233

  • Study site

    Bordeaux, 33030

  • Study site

    Bordeaux, 33077

  • Study site

    Boulogne-sur-Mer, 62321

  • Study site

    Bourg-en-Bresse, 01012

  • Study site

    Brest, 29200

  • Study site

    Brest, 29240

  • Study site

    Brive-la-Gaillarde, 19312

  • Study site

    Bron, 69677

  • Study site

    Bry-sur-Marne, 94366

  • Study site

    Caen, 14076

  • Study site

    Cagnes-sur-Mer, 06805

  • Study site

    Cahors, 46005

  • Study site

    Carcassonne, 11890

  • Study site

    Chalon-sur-Saône, 71100

  • Study site

    Chambray-lès-Tours, 37175

  • Study site

    Charleville-Mézières, 08011

  • Study site

    Châteauroux, 36019

  • Study site

    Chaumont, 52014

  • Study site

    Chauny, 02303

  • Study site

    Cherbourg Octeville, 50102

  • Study site

    Clamart, 92141

  • Study site

    Clermont-Ferrand, 63003

  • Study site

    Colmar, 68024

  • Study site

    Compiègne, 60204

  • Study site

    Compiègne, 60321

  • Study site

    Cornebarrieu, 31700

  • Study site

    Creil, 60109

  • Study site

    Créteil, 94010

  • Study site

    Dax, 40107

  • Study site

    Dijon, 21000

  • Study site

    Dunkirk, 59240

  • Study site

    Eaubonne, 95602

  • Study site

    Épernay, 51200

  • Study site

    Évreux, 27025

  • Study site

    Fontainebleau, 77305

  • Study site

    Gap, 05007

  • Study site

    Gleizé, 69400

  • Study site

    Granville, 50406

  • Study site

    Hyères, 83400

  • Study site

    La Chaussée-Saint-Victor, 41260

  • Study site

    La Roche-sur-Yon, 85925

  • Study site

    La Seyne-sur-Mer, 83500

  • Study site

    La Source, 45100

  • Study site

    Le Mans, 72015

  • Study site

    Le Perreux-sur-Marne, 94170

  • Study site

    Levallois-Perret, 92309

  • Study site

    Libourne, 33505

  • Study site

    Liévin, 62806

  • Study site

    Lille, 59003

  • Study site

    Lille, 59037

  • Study site

    Limoges, 87042

  • Study site

    Longjumeau, 91161

  • Study site

    Lorient, 56322

  • Study site

    Lormont, 33310

  • Study site

    Lyon, 69275

  • Study site

    Lyon, 69317

  • Study site

    Lyon, 69338

  • Study site

    Lyon, 69373

  • Study site

    Lyon, 69424

  • Study site

    Mareuil-lès-Meaux, 77100

  • Study site

    Marseille, 13274

  • Study site

    Maubeuge, 59604

  • Study site

    Meaux, 77104

  • Study site

    Metz, 57000

  • Study site

    Metz-Tessy, 74370

  • Study site

    Mont-de-Marsan, 40024

  • Study site

    Montauban, 82013

  • Study site

    Montélimar, 26216

  • Study site

    Montfermeil, 93370

  • Study site

    Montpellier, 34967

  • Study site

    Mulhouse, 68070

  • Study site

    Nancy, 54100

  • Study site

    Narbonne, 11108

  • Study site

    Nemours, 77796

  • Study site

    Neuilly-sur-Seine, 92521

  • Study site

    Nevers, 58033

  • Study site

    Osny, 95520

  • Study site

    Paris, 75015

  • Study site

    Paris, 75181

  • Study site

    Paris, 75571

  • Study site

    Paris, 75674

  • Study site

    Paris, 75877

  • Study site

    Paris, 75908

  • Study site

    Pau, 64046

  • Study site

    Perpignan, 66046

  • Study site

    Pierre-Bénite, 69495

  • Study site

    Pontarlier, 25304

  • Study site

    Pontoise, 95300

  • Study site

    Rambouillet, 78514

  • Study site

    Reims, 51056

  • Study site

    Reims, 51057

  • Study site

    Reims, 51100

  • Study site

    Rennes, 35033

  • Study site

    Rouen, 76000

  • Study site

    Rouen, 76044

  • Study site

    Saint-Aubin-lès-Elbeuf, 76410

  • Study site

    Saint-Herblain, 44805

  • Study site

    Saint-Jean, 31240

  • Study site

    Saint-Lô, 50009

  • Study site

    Saint-Priest-en-Jarez, 42271

  • Study site

    Saint-Quentin, 02321

  • Study site

    Saintes, 17108

  • Study site

    Senlis, 60309

  • Study site

    Soissons, 02209

  • Study site

    Ste Feyre, 23000

  • Study site

    Strasbourg, 67000

  • Study site

    Strasbourg, 67010

  • Study site

    Strasbourg, 67065

  • Study site

    Strasbourg, 67085

  • Study site

    Strasbourg, 67091

  • Study site

    Tarbes, 65000

  • Study site

    Thionville, 57126

  • Study site

    Thonon-les-Bains, 74203

  • Study site

    Toulon, 83041

  • Study site

    Toulon, 83056

  • Study site

    Toulouse, 31076

  • Study site

    Vandœuvre-lès-Nancy, 54511

  • Study site

    Vannes, 56001

  • Study site

    Vannes, 56017

  • Study site

    Vénissieux, 69200

  • Study site

    Verdun, 55107

  • Study site

    Versailles, 78004

  • Study site

    Vesoul, 70014

  • Study site

    Vichy, 3201

  • Study site

    Villeneuve-Saint-Georges, 94195

Other trials in France

About this study

Official title: A Cohort Study of First-line Treatment of Patients With Unresectable Advanced (Stage IIIB), Metastatic (Stage IV) or Recurrent Non Squamous Non-small Cell Lung Cancer (NSCLC), Starting a Treatment With Bevacizumab (Avastin®) in Combination With Chemotherapy.

This observational study will evaluate modality, efficacy and safety of Avastin (bevacizumab) as first-line treatment in combination with chemotherapy in patients with inoperable advanced, metastatic or recurrent non-squamous non-small cell lung cancer in clinical practice. Data will be collected for each patient for 18 months from initiation of Avastin therapy.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01333007
Study groupRoleWhat they receive
CohortNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    Measured: 18 months

Secondary outcomes (6)

  1. Clinical (diagnosis, therapies, comorbidity) and demographic characteristics of patients initiated on Avastin treatment

    Measured: 18 months

  2. Modality of treatment with Avastin (dose, duration, associated chemotherapy)

    Measured: 18 months

  3. Overall survival

    Measured: 18 months

  4. Safety: Incidence of adverse events

    Measured: 18 months

  5. Quality of Life: Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire

    Measured: 18 months

  6. Treatment of non-squamous NSCLC in clinical practice

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2011 (estimated)
  2. Study startJul 2010
  3. Primary completionMay 2013
  4. Study completionMay 2013

Resources

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
423 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01333007
Sponsor's protocol ID
ML22991
Status last verified
Nov 2016
First submitted
6 Apr 2011
Last updated
2 Nov 2016
Results posted
No

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 152 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 152 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: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01333007.

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.

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