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

NCT01488331 | Completed

• 1 other identifier: ML22973
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 92

Brief 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.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  24 months

Secondary Outcomes (5)

• Best treatment response

  24 months

• Overall survival

  24 months

• Safety (incidence of adverse events)

  24 months

• Type of treatment response

  24 months

• Treatment compliance of patient

  24 months

Study Arms (1)

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with non-small cell lung cancer

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (92)

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Abbeville, 80142, France

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Agen, 47000, France

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Aix-en-Provence, 13616, France

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Aix-en-Provence, 13617, France

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Ajaccio, 20176, France

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Amiens, 80090, France

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Angers, 49933, France

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Annecy, 74000, France

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Aubagne, 13400, France

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Auxerre, 89000, France

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Bastia, 20200, France

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Bordeaux, 33077, France

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Bourg-en-Bresse, 01012, France

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Brest, 29200, France

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Brest, 29240, France

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Bron, 69677, France

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Bry-sur-Marne, 94366, France

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Caen, 14076, France

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Cagnes-sur-Mer, 06805, France

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Chalon-sur-Saône, 71100, France

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Chambray-lès-Tours, 37175, France

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Chaumont, 52014, France

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Chauny, 02303, France

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Cholet, 49325, France

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Clamart, 92141, France

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Clermont-Ferrand, 63003, France

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Colmar, 68024, France

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Compiègne, 60321, France

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Coquelles, 62231, France

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Cornebarrieu, 31700, France

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Creil, 60109, France

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Créteil, 94010, France

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Dax, 40107, France

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Dijon, 21079, France

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Draguignan, 83007, France

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Eaubonne, 95602, France

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Fréjus, 83608, France

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Gap, 05007, France

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Gleizé, 69400, France

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Helfaut, 62570, France

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Hyères, 83400, France

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La Chaussée-Saint-Victor, 41260, France

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La Roche-sur-Yon, 85925, France

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La Rochelle, 17019, France

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La Source, 45100, France

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La Tronche, 38700, France

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Le Plessis-Robinson, 92350, France

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Libourne, 33505, France

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Limoges, 87042, France

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Longjumeau, 91161, France

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Lyon, 69275, France

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Lyon, 69365, France

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Meaux, 77104, France

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Metz, 57000, France

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Meudon, 92360, France

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Montauban, 82013, France

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Montpellier, 34070, France

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Mulhouse, 68070, France

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Nancy, 54100, France

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Nantes, 44202, France

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Nevers, 58033, France

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Paris, 75230, France

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Paris, 75571, France

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Paris, 75908, France

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Perpignan, 66012, France

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Perpignan, 66046, France

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Pierre-Bénite, 69495, France

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Pontoise, 95300, France

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Reims, 51056, France

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Reims, 51057, France

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Rennes, 35033, France

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Rouen, 76000, France

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Saint-Aubin-lès-Elbeuf, 76410, France

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Saint-Avold, 57502, France

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Saint-Brieuc, 22027, France

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Saint-Jean, 31240, France

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Saint-Priest-en-Jarez, 42271, France

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Saint-Priest-en-Jarez, 42770, France

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Saint-Quentin, 02321, France

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Salon-de-Provence, 13300, France

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Senlis, 60309, France

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Strasbourg, 67010, France

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Strasbourg, 67065, France

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Strasbourg, 67091, France

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Tarbes, 65000, France

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Thionville, 57126, France

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Toulon, 83041, France

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Toulon, 83056, France

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Toulouse, 31059, France

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Tours, 37044, France

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Vénissieux, 69200, France

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Vichy, 3201, France

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: December 8, 2011
• Study Start: June 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

FR (92)