Clinical trial NCT01488331: An Observational Study of Tarceva (Erlotinib) in Patients With Non-Small Cell Lung Cancer
Official title: A Patient Cohort With Locally Advanced or Metastatic Non-small Cell Lung Cancer Treated With Tarceva (Erlotinib) Monotherapy and Not Progressing After at Least 9 Months
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-12-08
Enrollment: 217
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: Adult patients with non-small cell lung cancer

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.


Eligibility criteria: 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:

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

Primary outcomes:
measure: Progression-free survival
timeFrame: 24 months
Secondary outcomes:
measure: Best treatment response
timeFrame: 24 months
measure: Overall survival
timeFrame: 24 months
measure: Safety (incidence of adverse events)
timeFrame: 24 months
measure: Type of treatment response
timeFrame: 24 months
measure: Treatment compliance of patient
timeFrame: 24 months
Other outcomes:
Locations:
city: Abbeville
country: France
city: Agen
country: France
city: Aix En Provence
country: France
city: Aix En Provence
country: France
city: Ajaccio
country: France
city: Amiens
country: France
city: Angers
country: France
city: Annecy
country: France
city: Aubagne
country: France
city: Auxerre
country: France
city: Bastia
country: France
city: Bordeaux
country: France
city: Bourg En Bresse
country: France
city: Brest
country: France
city: Brest
country: France
city: Bron
country: France
city: Bry Sur Marne
country: France
city: Caen
country: France
city: Cagnes Sur Mer
country: France
city: Chalon Sur Saone
country: France
city: Chambray Les Tours
country: France
city: Chaumont
country: France
city: Chauny
country: France
city: Cholet
country: France
city: Clamart
country: France
city: Clermont-ferrand
country: France
city: Colmar
country: France
city: Compiegne
country: France
city: Coquelles
country: France
city: Cornebarrieu
country: France
city: Creil
country: France
city: Creteil
country: France
city: DAX
country: France
city: Dijon
country: France
city: Draguignan
country: France
city: Eaubonne
country: France
city: Frejus
country: France
city: GAP
country: France
city: Gleize
country: France
city: Helfaut
country: France
city: Hyeres
country: France
city: La Chaussee St Victor
country: France
city: La Roche Sur Yon
country: France
city: La Rochelle
country: France
city: La Source
country: France
city: La Tronche
country: France
city: Le Plessis Robinson
country: France
city: Libourne
country: France
city: Limoges
country: France
city: Longjumeau
country: France
city: Lyon
country: France
city: Lyon
country: France
city: Meaux
country: France
city: Metz
country: France
city: Meudon
country: France
city: Montauban
country: France
city: Montpellier
country: France
city: Mulhouse
country: France
city: Nancy
country: France
city: Nantes
country: France
city: Nevers
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: Pontoise
country: France
city: Reims
country: France
city: Reims
country: France
city: Rennes
country: France
city: Rouen
country: France
city: Saint Jean
country: France
city: Saint Priest En Jarez
country: France
city: Salon de Provence
country: France
city: Senlis
country: France
city: St Aubin Les Elbeuf
country: France
city: St Avold
country: France
city: St Brieuc
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: Tarbes
country: France
city: Thionville
country: France
city: Toulon
country: France
city: Toulon
country: France
city: Toulouse
country: France
city: Tours
country: France
city: Venissieux
country: France
city: Vichy
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: