Clinical trial NCT01723878: ASPET Study: An Observational Study of Tarceva (Erlotinib) in First Line in Patients With Advanced Non-Small Cell Lung Cancer Harbouring EGFR Activating Mutations
Official title: Observational, Post-authorization, Prospective Study for Evaluating Patterns of Disease Progression in Patients With Advanced Non-small-cell Lung Carcinoma (NSCLC) Harbouring EGFR Activating Mutations Treated With Erlotinib in First Line.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-11-08
Enrollment: 144
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 advanced non-small cell lung cancer (NSCLC) with EGFR activating mutations receiving first-line treatment with Tarceva

Brief summary: This observational study will evaluate the patterns of disease progression in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR activating mutations receiving Tarceva (erlotinib) as first-line treatment. Patients will be followed for up to 12 months after progression of disease.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically or cytologically confirmed locally advanced or metastatic (IIIB/IV) non-squamous non-small cell lung cancer (NSCLC) which is routinely evaluated in clinical practice according to RECIST criteria
* EGFR mutation-positive disease according to local laboratory testing
* Patients on treatment with Tarceva monotherapy as first-line treatment according to the physician's usual practice

Exclusion Criteria:

* Prior systemic therapy for advanced NSCLC. The administration of neoadjuvant or adjuvant chemotherapy is allowed as long as it was finalized \>6 months prior to receiving Tarceva
* Participation in another clinical study
* Patients could have received radiotherapy as long as the irradiated lesion was not the only lesion for evaluating response and a long as the radiotherapy was completed before initiating Tarceva treatment

Primary outcomes:
measure: Progression-free survival (time from initiation of treatment to disease progression or death of any cause) in correlation with localization of progression and clinical tumor characteristics
timeFrame: 3 years
Secondary outcomes:
measure: Objective response rate, tumor assessments according to RECIST v1.1 criteria
timeFrame: 3 years
measure: One-year overall survival (from initiation of treatment to 12 months after disease progression)
timeFrame: 3 years
measure: Time to progression
timeFrame: 3 years
measure: Exposure (dosage/duration) with first-line Tarceva in clinical practice
timeFrame: 3 years
measure: Safety: Incidence of adverse events
timeFrame: 3 years
measure: Velocity of progression (disease flares) after cessation of treatment with Tarceva following disease progression
timeFrame: 3 years
measure: Treatments used after disease progression in clinical practice
timeFrame: 3 years
Other outcomes:
Locations:
city: Alcoy
country: Spain
facility: Hospital Virgen de los Lirios; Servicio de Oncologia
state: Alicante
city: Oviedo
country: Spain
facility: Hospital Univ. Central de Asturias
state: Asturias
city: Granollers
country: Spain
facility: Hospital General de Granollers; Servicio de Oncologia
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa; Servicio de Oncologia
state: Barcelona
city: Cádiz
country: Spain
facility: Hospital Universitario Puerta del Mar; Servicio de Oncologia
state: Cadiz
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
state: Cantabria
city: San Sebastian de Los Reyes
country: Spain
facility: Hospital Infanta Sofia; Servico de Oncologia
state: Guipuzcoa
city: San Sebastian
country: Spain
facility: Hospital de Donostia; Servicio de Oncologia Medica
state: Guipuzcoa
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases; Servicio de Oncologia
state: Islas Baleares
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer; Servicio de Oncologia
state: Islas Baleares
city: Lanzarote
country: Spain
facility: Hospital General de Lanzarote
state: Las Palmas
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia
state: Las Palmas
city: Alcala de Henares
country: Spain
facility: Hospital Universitario Principe de Asturias; Servicio de Oncologia
state: Madrid
city: Alcorcon
country: Spain
facility: Fundacion Hospital de Alcorcon; Servicio de Oncologia
state: Madrid
city: Coslada
country: Spain
facility: Hospital del Henares; Servicio de Oncologia
state: Madrid
city: Vigo
country: Spain
facility: Hospital Meixoeiro
state: Pontevedra
city: La Laguna (Tenerife)
country: Spain
facility: Hospital Universitario de Canarias (HUC)
state: Tenerife
city: Santa Cruz de Tenerife
country: Spain
facility: Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia
state: Tenerife
city: Sagunto
country: Spain
facility: Hospital de Sagunto; Servicio de Oncologia
state: Valencia
city: Xativa
country: Spain
facility: Hospital Lluis Alcanys; Servicio de Oncologia
state: Valencia
city: Barakaldo
country: Spain
facility: Hospital de Cruces; Servicio de Oncologia
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia; Servicio de Oncologia
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio; Servicio de Oncologia
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
city: Leon
country: Spain
facility: Complejo Asistencial Universitario de Leon; Servicio de Oncologia
city: Lugo
country: Spain
facility: Complejo Hospitalario Xeral-Cies
city: Madrid
country: Spain
facility: Hospital Universitario La Paz; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario de Mostoles;Servicio de Oncologia
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Hematologia
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
city: Orense
country: Spain
facility: Complejo Hospitalario de Orense; Servicio de Oncologia
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
city: Segovia
country: Spain
facility: Hospital General de Segovia; Servicio de Oncologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia
city: Teruel
country: Spain
facility: Hospital General de Teruel Obispo Polanco; Servicio Oncologia
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset; Servicio de Oncologia
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid; Servicio de Oncologia
city: Zamora
country: Spain
facility: Complejo Hospitalario Zamora- H. Virgen de la Concha; Servicio Oncologia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet; Servicio Oncologia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: