ASPET Study: An Observational Study of Tarceva (Erlotinib) in First Line in Patients With Advanced Non-Small Cell Lung Cancer Harbouring EGFR Activating Mutations
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Registration Number
- NCT01723878
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 144
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 3 years
- Secondary Outcome Measures
Name Time Method Objective response rate, tumor assessments according to RECIST v1.1 criteria 3 years One-year overall survival (from initiation of treatment to 12 months after disease progression) 3 years Treatments used after disease progression in clinical practice 3 years Time to progression 3 years Exposure (dosage/duration) with first-line Tarceva in clinical practice 3 years Safety: Incidence of adverse events 3 years Velocity of progression (disease flares) after cessation of treatment with Tarceva following disease progression 3 years
Trial Locations
- Locations (43)
Hospital General de Granollers; Servicio de Oncologia
🇪🇸Granollers, Barcelona, Spain
Hospital General de Teruel Obispo Polanco; Servicio Oncologia
🇪🇸Teruel, Spain
Complejo Asistencial Universitario de Leon; Servicio de Oncologia
🇪🇸Leon, Spain
Hospital Univ. Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Hospital de Donostia; Servicio de Oncologia Medica
🇪🇸San Sebastian, Guipuzcoa, Spain
Hospital Mutua de Terrassa; Servicio de Oncologia
🇪🇸Terrassa, Barcelona, Spain
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
🇪🇸Santander, Cantabria, Spain
Hospital Universitario Puerta del Mar; Servicio de Oncologia
🇪🇸Cádiz, Cadiz, Spain
Hospital General de Lanzarote
🇪🇸Lanzarote, Las Palmas, Spain
Hospital Universitario de Canarias (HUC)
🇪🇸La Laguna (Tenerife), Tenerife, Spain
Hospital Meixoeiro
🇪🇸Vigo, Pontevedra, Spain
Hospital Infanta Sofia; Servico de Oncologia
🇪🇸San Sebastian de Los Reyes, Guipuzcoa, Spain
Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia
🇪🇸Santa Cruz de Tenerife, Tenerife, Spain
Hospital de Cruces; Servicio de Oncologia
🇪🇸Barakaldo, Vizcaya, Spain
Hospital Universitario San Cecilio; Servicio de Oncologia
🇪🇸Granada, Spain
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
🇪🇸Salamanca, Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia
🇪🇸Sevilla, Spain
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
🇪🇸Valencia, Spain
Hospital de Sagunto; Servicio de Oncologia
🇪🇸Sagunto, Valencia, Spain
Hospital Universitario Principe de Asturias; Servicio de Oncologia
🇪🇸Alcala de Henares, Madrid, Spain
Hospital Lluis Alcanys; Servicio de Oncologia
🇪🇸Xativa, Valencia, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
🇪🇸Barcelona, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia
🇪🇸Cordoba, Spain
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
🇪🇸Jaen, Spain
Hospital Universitario La Paz; Servicio de Oncologia
🇪🇸Madrid, Spain
Complejo Hospitalario Xeral-Cies
🇪🇸Lugo, Spain
Hospital Universitario de Mostoles;Servicio de Oncologia
🇪🇸Madrid, Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Hematologia
🇪🇸Malaga, Spain
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
🇪🇸Murcia, Spain
Complejo Hospitalario de Orense; Servicio de Oncologia
🇪🇸Orense, Spain
Hospital Universitario Dr. Peset; Servicio de Oncologia
🇪🇸Valencia, Spain
Hospital General de Segovia; Servicio de Oncologia
🇪🇸Segovia, Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
🇪🇸Zaragoza, Spain
Hospital Clinico Universitario de Valladolid; Servicio de Oncologia
🇪🇸Valladolid, Spain
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
🇪🇸Madrid, Spain
Hospital Virgen de los Lirios; Servicio de Oncologia
🇪🇸Alcoy, Alicante, Spain
Fundacion Hospital de Alcorcon; Servicio de Oncologia
🇪🇸Alcorcon, Madrid, Spain
Hospital del Henares; Servicio de Oncologia
🇪🇸Coslada, Madrid, Spain
Complejo Hospitalario Zamora- H. Virgen de la Concha; Servicio Oncologia
🇪🇸Zamora, Spain
Hospital Universitario Son Espases; Servicio de Oncologia
🇪🇸Palma De Mallorca, Islas Baleares, Spain
Hospital Son Llatzer; Servicio de Oncologia
🇪🇸Palma de Mallorca, Islas Baleares, Spain
Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia
🇪🇸Las Palmas de Gran Canaria, Las Palmas, Spain