Clinical trial NCT01659970: PEPITA Study: An Observational Study of Tarceva (Erlotinib) in Second Line in Patients With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-08
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with locally advanced or metastatic squamous NSCLC initiating 2nd line treatment with Tarceva

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Clinical/demographic patients characteristics at baseline
timeFrame: 2 years
measure: Treatment schedules: Dose/duration/modifications/interruptions
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
measure: Safety: Incidence of adverse events
timeFrame: 2 years
measure: Quality of life: FACT-L version 4 questionnaire
timeFrame: 2 years
Other outcomes:
Locations:
city: Abbeville
country: France
city: Agen
country: France
city: Aix En Provence
country: France
city: Aix En Provence
country: France
city: Amiens
country: France
city: Angers
country: France
city: Antibes
country: France
city: Armentieres
country: France
city: Aulnay Sous Bois
country: France
city: Bar Le Duc
country: France
city: Bayonne
country: France
city: Beuvry
country: France
city: Bordeaux
country: France
city: Boulogne-billancourt
country: France
city: Bourg En Bresse
country: France
city: Brive La Gaillarde
country: France
city: Bron
country: France
city: Bry Sur Marne
country: France
city: Carcassonne
country: France
city: Castres
country: France
city: Chalon Sur Saone
country: France
city: Chambery
country: France
city: Charleville Mezieres
country: France
city: Chaumont
country: France
city: Chauny
country: France
city: Clamart
country: France
city: Clermont-ferrand
country: France
city: Colmar
country: France
city: Compiegne
country: France
city: Creteil
country: France
city: Dijon
country: France
city: Dijon
country: France
city: Draguignan
country: France
city: Dunkerque
country: France
city: Epernay
country: France
city: Ermont
country: France
city: Ferolles Attilly
country: France
city: Forbach
country: France
city: GAP
country: France
city: Gleize
country: France
city: Gonesse
country: France
city: La Rochelle
country: France
city: La Source
country: France
city: La Tronche
country: France
city: Lagny Sur Marne
country: France
city: Le Mans
country: France
city: Le Mans
country: France
city: Le Puy En Velay
country: France
city: Lille
country: France
city: Lille
country: France
city: Lille
country: France
city: Limoges
country: France
city: Lisieux
country: France
city: Longjumeau
country: France
city: Lorient
country: France
city: Lyon
country: France
city: Lyon
country: France
city: Manosque
country: France
city: Mantes La Jolie
country: France
city: Mareuil Les Meaux
country: France
city: Marseille
country: France
city: Meaux
country: France
city: Metz Tessy
country: France
city: Metz
country: France
city: Mont-de-marsan
country: France
city: Montpellier
country: France
city: Nancy
country: France
city: Nantes
country: France
city: Narbonne
country: France
city: Neuilly Sur Seine
country: France
city: Neuilly-sur-seine
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Perpignan
country: France
city: Perpignan
country: France
city: Pierre Benite
country: France
city: Poitiers
country: France
city: Pontoise
country: France
city: Quimper
country: France
city: Rambouillet
country: France
city: Reims CEDEX
country: France
city: Reims
country: France
city: Rennes
country: France
city: Rouen
country: France
city: Rouen
country: France
city: Saint Jean
country: France
city: Saint Laurent Du Var
country: France
city: Saint Priest En Jarez
country: France
city: Saintes
country: France
city: St Die Des Vosges
country: France
city: St Dizier
country: France
city: St Omer
country: France
city: St Quentin
country: France
city: St-Priest-En-Jarez
country: France
city: Strasbourg
country: France
city: Strasbourg
country: France
city: Strasbourg
country: France
city: Strasbourg
country: France
city: Thionville
country: France
city: Thonon-les-bains
country: France
city: Toulon
country: France
city: Toulon
country: France
city: Toulouse
country: France
city: Tours
country: France
city: Valence
country: France
city: Vandoeuvre-les-nancy
country: France
city: Vannes
country: France
city: Venissieux
country: France
city: Verdun
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: