PEPITA Study: An Observational Study of Tarceva (Erlotinib) in Second Line in Patients With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

NCT01659970 | Completed

• 1 other identifier: ML28195
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 110

Brief Summary

This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in second line in patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after failure of first line platinum-based chemotherapy. Eligible patients will be followed for 12 months.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  2 years

Secondary Outcomes (5)

• Clinical/demographic patients characteristics at baseline

  2 years

• Treatment schedules: Dose/duration/modifications/interruptions

  2 years

• Overall survival

  2 years

• Safety: Incidence of adverse events

  2 years

• Quality of life: FACT-L version 4 questionnaire

  2 years

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

Patients with locally advanced or metastatic squamous NSCLC initiating 2nd line treatment with Tarceva

You may qualify if:

• Adult patients, \>/= 18 years of age
• Histologically or cytologically confirmed advanced (Stage IIIB) or metastatic (Stage IV) squamous non-small cell lung cancer after failure of first-line platinum-based chemotherapy
• Patients for whom the treating physician has decided to initiate treatment with Tarceva

You may not qualify if:

• Mixed non-small cell and small-cell lung carcinoma or mixed squamous cell carcinoma with predominant adenocarcinoma component
• Current participation in a clinical trial evaluating an anticancer treatment

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (110)

Unknown Facility

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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Amiens, 80090, France

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Angers, 49933, France

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Antibes, 06600, France

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Armentières, 59421, France

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Aulnay-sous-Bois, 93602, France

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Bar-le-Duc, 55012, France

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Bayonne, 64100, France

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Beuvry, 62660, France

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Bordeaux, 33000, France

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Boulogne-Billancourt, 92100, France

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Bourg-en-Bresse, 01012, France

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Brive-la-Gaillarde, 19312, France

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Bron, 69677, France

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Bry-sur-Marne, 94366, France

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Carcassonne, 11890, France

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Castres, 81108, France

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Chalon-sur-Saône, 71100, France

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Chambéry, 73011, France

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Charleville-Mézières, 08011, France

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Chaumont, 52014, France

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Chauny, 02303, 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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Créteil, 94010, France

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Dijon, 21000, France

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Dijon, 21079, France

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Draguignan, 83007, France

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Dunkirk, 59240, France

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Ermont, 95120, France

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Épernay, 51205, France

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Férolles-Attilly, 77150, France

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Forbach, 57604, France

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Gap, 05007, France

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Gleizé, 69400, France

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Gonesse, 95503, 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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Lagny-sur-Marne, 77405, France

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Le Mans, 72015, France

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Le Mans, 72037, France

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Le Puy-en-Velay, 43012, France

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Lille, 59000, France

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Lille, 59037, France

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Lille, 59042, France

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Limoges, 87042, France

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Lisieux, 14107, France

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Longjumeau, 91161, France

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Lorient, 56322, France

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Lyon, 69275, France

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Lyon, 69365, France

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Manosque, 04101, France

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Mantes-la-Jolie, 78200, France

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Mareuil-lès-Meaux, 77100, France

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Marseille, 13291, France

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Meaux, 77104, France

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Metz, 57038, France

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Metz-Tessy, 74370, France

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Mont-de-Marsan, 40024, France

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Montpellier, 34070, France

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Nancy, 54100, France

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Nantes, 44202, France

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Narbonne, 11780, France

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Neuilly-sur-Seine, 92200, France

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Paris, 75231, France

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Paris, 75475, France

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Paris, 75908, France

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Paris, 75970, France

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Perpignan, 66000, France

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Perpignan, 66046, France

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Pierre-Bénite, 69495, France

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Poitiers, 86021, France

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Pontoise, 95300, France

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Quimper, 29000, France

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Rambouillet, 78514, France

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Reims, 51056, France

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Reims, 51100, France

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Rennes, 35033, France

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Rouen, 76000, France

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Rouen, 76031, France

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Saint-Dié, 88187, France

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Saint-Dizier, 52115, France

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Saint-Jean, 31240, France

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Saint-Laurent-du-Var, 06700, France

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Saint-Omer, 62500, 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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Saintes, 17108, France

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Strasbourg, 67000, 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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Thionville, 57126, France

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Thonon-les-Bains, 74203, France

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Toulon, 83041, France

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Toulon, 83056, France

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Toulouse, 31076, France

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Tours, 37000, France

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Valence, 26000, France

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Vandœuvre-lès-Nancy, 54511, France

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Vannes, 56017, France

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Verdun, 55107, France

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Vénissieux, 69200, France

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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: August 6, 2012
• First Posted: August 8, 2012
• Study Start: June 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

FR (110)