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

November 1, 2016 updated by: Hoffmann-La Roche

A Prospective Cohort Study Assessing the Efficacy and Safety of Tarceva in 2nd Line in Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

152

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
      • Amiens, France, 80090
      • Angers, France, 49933
      • Antibes, France, 06600
      • Armentieres, France, 59421
      • Aulnay Sous Bois, France, 93602
      • Bar Le Duc, France, 55012
      • Bayonne, France, 64100
      • Beuvry, France, 62660
      • Bordeaux, France, 33000
      • Boulogne-billancourt, France, 92100
      • Bourg En Bresse, France, 01012
      • Brive La Gaillarde, France, 19312
      • Bron, France, 69677
      • Bry Sur Marne, France, 94366
      • Carcassonne, France, 11890
      • Castres, France, 81108
      • Chalon Sur Saone, France, 71100
      • Chambery, France, 73011
      • Charleville Mezieres, France, 08011
      • Chaumont, France, 52014
      • Chauny, France, 02303
      • Clamart, France, 92141
      • Clermont-ferrand, France, 63003
      • Colmar, France, 68024
      • Compiegne, France, 60321
      • Creteil, France, 94010
      • Dijon, France, 21000
      • Dijon, France, 21079
      • Draguignan, France, 83007
      • Dunkerque, France, 59240
      • Epernay, France, 51205
      • Ermont, France, 95120
      • Ferolles Attilly, France, 77150
      • Forbach, France, 57604
      • GAP, France, 05007
      • Gleize, France, 69400
      • Gonesse, France, 95503
      • La Rochelle, France, 17019
      • La Source, France, 45100
      • La Tronche, France, 38700
      • Lagny Sur Marne, France, 77405
      • Le Mans, France, 72037
      • Le Mans, France, 72015
      • Le Puy En Velay, France, 43012
      • Lille, France, 59037
      • Lille, France, 59042
      • Lille, France, 59000
      • Limoges, France, 87042
      • Lisieux, France, 14107
      • Longjumeau, France, 91161
      • Lorient, France, 56322
      • Lyon, France, 69365
      • Lyon, France, 69275
      • Manosque, France, 04101
      • Mantes La Jolie, France, 78200
      • Mareuil Les Meaux, France, 77100
      • Marseille, France, 13291
      • Meaux, France, 77104
      • Metz, France, 57038
      • Metz Tessy, France, 74370
      • Mont-de-marsan, France, 40024
      • Montpellier, France, 34070
      • Nancy, France, 54100
      • Nantes, France, 44202
      • Narbonne, France, 11780
      • Neuilly Sur Seine, France, 92200
      • Neuilly-sur-seine, France, 92200
      • Paris, France, 75970
      • Paris, France, 75908
      • Paris, France, 75475
      • Paris, France, 75231
      • Perpignan, France, 66046
      • Perpignan, France, 66000
      • Pierre Benite, France, 69495
      • Poitiers, France, 86021
      • Pontoise, France, 95300
      • Quimper, France, 29000
      • Rambouillet, France, 78514
      • Reims, France, 51100
      • Reims CEDEX, France, 51056
      • Rennes, France, 35033
      • Rouen, France, 76031
      • Rouen, France, 76000
      • Saint Jean, France, 31240
      • Saint Laurent Du Var, France, 06700
      • Saint Priest En Jarez, France, 42770
      • Saintes, France, 17108
      • St Die Des Vosges, France, 88187
      • St Dizier, France, 52115
      • St Omer, France, 62500
      • St Quentin, France, 02321
      • St-Priest-En-Jarez, France, 42271
      • Strasbourg, France, 67091
      • Strasbourg, France, 67010
      • Strasbourg, France, 67065
      • Strasbourg, France, 67000
      • Thionville, France, 57126
      • Thonon-les-bains, France, 74203
      • Toulon, France, 83056
      • Toulon, France, 83041
      • Toulouse, France, 31076
      • Tours, France, 37000
      • Valence, France, 26000
      • Vandoeuvre-les-nancy, France, 54511
      • Vannes, France, 56017
      • Venissieux, France, 69200
      • Verdun, France, 55107

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

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 2 years
2 years
Safety: Incidence of adverse events
Time Frame: 2 years
2 years
Clinical/demographic patients characteristics at baseline
Time Frame: 2 years
2 years
Treatment schedules: Dose/duration/modifications/interruptions
Time Frame: 2 years
2 years
Quality of life: FACT-L version 4 questionnaire
Time Frame: 2 years
2 years

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, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

August 6, 2012

First Submitted That Met QC Criteria

August 6, 2012

First Posted (Estimate)

August 8, 2012

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

  • ML28195

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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