CClinicalTrials.gg
CompletedNCT01488331Updated Nov 2, 2016

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

An observational study in Non-Squamous Non-Small Cell Lung Cancer, sponsored by Hoffmann-La Roche. Completed at 92 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Hoffmann-La Roche · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
217
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Non-Squamous Non-Small Cell Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 217 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients with non-small cell lung cancer

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

Exclusion Criteria:

  • Not agreeing to be followed-up (for a maximum of 24 months)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
217 participants (actual)

Groups and cohorts

  • Cohort
06

What researchers measure

Primary outcomes

  1. Progression-free survival

    Time frame: 24 months

Secondary outcomes

  1. Best treatment response

    Time frame: 24 months

  2. Overall survival

    Time frame: 24 months

  3. Safety (incidence of adverse events)

    Time frame: 24 months

  4. Type of treatment response

    Time frame: 24 months

  5. Treatment compliance of patient

    Time frame: 24 months

07

Study locations

92 sites
  • Abbeville, 80142, France
  • Agen, 47000, France
  • Aix En Provence, 13616, France
  • Aix En Provence, 13617, France
  • Ajaccio, 20176, France
  • Amiens, 80090, France
  • Angers, 49933, France
  • Annecy, 74000, France
  • Aubagne, 13400, France
  • Auxerre, 89000, France
  • Bastia, 20200, France
  • Bordeaux, 33077, France
  • Bourg En Bresse, 01012, France
  • Brest, 29200, France
  • Brest, 29240, France
  • Bron, 69677, France
  • Bry Sur Marne, 94366, France
  • Caen, 14076, France
  • Cagnes Sur Mer, 06805, France
  • Chalon Sur Saone, 71100, France
  • Chambray Les Tours, 37175, France
  • Chaumont, 52014, France
  • Chauny, 02303, France
  • Cholet, 49325, France
  • Clamart, 92141, France
  • Clermont-ferrand, 63003, France
  • Colmar, 68024, France
  • Compiegne, 60321, France
  • Coquelles, 62231, France
  • Cornebarrieu, 31700, France
  • Creil, 60109, France
  • Creteil, 94010, France
  • DAX, 40107, France
  • Dijon, 21079, France
  • Draguignan, 83007, France
  • Eaubonne, 95602, France
  • Frejus, 83608, France
  • GAP, 05007, France
  • Gleize, 69400, France
  • Helfaut, 62570, France
  • Hyeres, 83400, France
  • La Chaussee St Victor, 41260, France
  • La Roche Sur Yon, 85925, France
  • La Rochelle, 17019, France
  • La Source, 45100, France
  • La Tronche, 38700, France
  • Le Plessis Robinson, 92350, France
  • Libourne, 33505, France
  • Limoges, 87042, France
  • Longjumeau, 91161, France
  • Lyon, 69275, France
  • Lyon, 69365, France
  • Meaux, 77104, France
  • Metz, 57000, France
  • Meudon, 92360, France
  • Montauban, 82013, France
  • Montpellier, 34070, France
  • Mulhouse, 68070, France
  • Nancy, 54100, France
  • Nantes, 44202, France
  • Nevers, 58033, France
  • Paris, 75230, France
  • Paris, 75571, France
  • Paris, 75908, France
  • Perpignan, 66012, France
  • Perpignan, 66046, France
  • Pierre Benite, 69495, France
  • Pontoise, 95300, France
  • Reims, 51056, France
  • Reims, 51057, France
  • Rennes, 35033, France
  • Rouen, 76000, France
  • Saint Jean, 31240, France
  • Saint Priest En Jarez, 42770, France
  • Salon de Provence, 13300, France
  • Senlis, 60309, France
  • St Aubin Les Elbeuf, 76410, France
  • St Avold, 57502, France
  • St Brieuc, 22027, France
  • St Quentin, 02321, France
  • St-Priest-En-Jarez, 42271, France
  • Strasbourg, 67010, France
  • Strasbourg, 67065, France
  • Strasbourg, 67091, France
  • Tarbes, 65000, France
  • Thionville, 57126, France
  • Toulon, 83041, France
  • Toulon, 83056, France
  • Toulouse, 31059, France
  • Tours, 37044, France
  • Venissieux, 69200, France
  • Vichy, 3201, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01488331
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Dec 8, 2011
Start date
Jun 2010
Primary completion
Nov 2013
Completion
Nov 2013
Last update
Nov 2, 2016

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion