An Observational Study of Tarceva (Erlotinib) in Patients With Non-Small Cell Lung Cancer

November 1, 2016 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

217

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Abbeville, France, 80142
      • Agen, France, 47000
      • Aix En Provence, France, 13616
      • Aix En Provence, France, 13617
      • Ajaccio, France, 20176
      • Amiens, France, 80090
      • Angers, France, 49933
      • Annecy, France, 74000
      • Aubagne, France, 13400
      • Auxerre, France, 89000
      • Bastia, France, 20200
      • Bordeaux, France, 33077
      • Bourg En Bresse, France, 01012
      • Brest, France, 29200
      • Brest, France, 29240
      • Bron, France, 69677
      • Bry Sur Marne, France, 94366
      • Caen, France, 14076
      • Cagnes Sur Mer, France, 06805
      • Chalon Sur Saone, France, 71100
      • Chambray Les Tours, France, 37175
      • Chaumont, France, 52014
      • Chauny, France, 02303
      • Cholet, France, 49325
      • Clamart, France, 92141
      • Clermont-ferrand, France, 63003
      • Colmar, France, 68024
      • Compiegne, France, 60321
      • Coquelles, France, 62231
      • Cornebarrieu, France, 31700
      • Creil, France, 60109
      • Creteil, France, 94010
      • DAX, France, 40107
      • Dijon, France, 21079
      • Draguignan, France, 83007
      • Eaubonne, France, 95602
      • Frejus, France, 83608
      • GAP, France, 05007
      • Gleize, France, 69400
      • Helfaut, France, 62570
      • Hyeres, France, 83400
      • La Chaussee St Victor, France, 41260
      • La Roche Sur Yon, France, 85925
      • La Rochelle, France, 17019
      • La Source, France, 45100
      • La Tronche, France, 38700
      • Le Plessis Robinson, France, 92350
      • Libourne, France, 33505
      • Limoges, France, 87042
      • Longjumeau, France, 91161
      • Lyon, France, 69365
      • Lyon, France, 69275
      • Meaux, France, 77104
      • Metz, France, 57000
      • Meudon, France, 92360
      • Montauban, France, 82013
      • Montpellier, France, 34070
      • Mulhouse, France, 68070
      • Nancy, France, 54100
      • Nantes, France, 44202
      • Nevers, France, 58033
      • Paris, France, 75908
      • Paris, France, 75571
      • Paris, France, 75230
      • Perpignan, France, 66046
      • Perpignan, France, 66012
      • Pierre Benite, France, 69495
      • Pontoise, France, 95300
      • Reims, France, 51056
      • Reims, France, 51057
      • Rennes, France, 35033
      • Rouen, France, 76000
      • Saint Jean, France, 31240
      • Saint Priest En Jarez, France, 42770
      • Salon de Provence, France, 13300
      • Senlis, France, 60309
      • St Aubin Les Elbeuf, France, 76410
      • St Avold, France, 57502
      • St Brieuc, France, 22027
      • St Quentin, France, 02321
      • St-Priest-En-Jarez, France, 42271
      • Strasbourg, France, 67091
      • Strasbourg, France, 67010
      • Strasbourg, France, 67065
      • Tarbes, France, 65000
      • Thionville, France, 57126
      • Toulon, France, 83056
      • Toulon, France, 83041
      • Toulouse, France, 31059
      • Tours, France, 37044
      • Venissieux, France, 69200
      • Vichy, France, 3201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients with non-small cell lung cancer

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Not agreeing to be followed-up (for a maximum of 24 months)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 24 months
24 months
Best treatment response
Time Frame: 24 months
24 months
Safety (incidence of adverse events)
Time Frame: 24 months
24 months
Type of treatment response
Time Frame: 24 months
24 months
Treatment compliance of patient
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

December 6, 2011

First Submitted That Met QC Criteria

December 7, 2011

First Posted (Estimate)

December 8, 2011

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML22973

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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