ASPET Study: An Observational Study of Tarceva (Erlotinib) in First Line in Patients With Advanced Non-Small Cell Lung Cancer Harbouring EGFR Activating Mutations

NCT01723878 | Completed

• 1 other identifier: ML28361
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 43

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.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• Time to progression

  3 years

• Exposure (dosage/duration) with first-line Tarceva in clinical practice

  3 years

• Safety: Incidence of adverse events

  3 years

Study Arms (1)

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (43)

Hospital Virgen de los Lirios; Servicio de Oncologia

Alcoy, Alicante, 03804, Spain

Location

Hospital Universitario Son Espases; Servicio de Oncologia

Palma de Mallorca, Balearic Islands, 07014, Spain

Location

Hospital Son Llatzer; Servicio de Oncologia

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Hospital General de Granollers; Servicio de Oncologia

Granollers, Barcelona, 08400, Spain

Location

Hospital Mutua de Terrassa; Servicio de Oncologia

Terrassa, Barcelona, 08221, Spain

Location

Hospital Universitario Puerta del Mar; Servicio de Oncologia

Cadiz, Cadiz, 11009, Spain

Location

Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

Santander, Cantabria, 39008, Spain

Location

Hospital de Donostia; Servicio de Oncologia Medica

Donostia / San Sebastian, Guipuzcoa, 20080, Spain

Location

Hospital Infanta Sofia; Servico de Oncologia

San Sebastián de los Reyes, Guipuzcoa, 28702, Spain

Location

Hospital General de Lanzarote

Lanzarote, Las Palmas, Spain

Location

Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia

Las Palmas de Gran Canaria, Las Palmas, 35020, Spain

Location

Hospital Universitario Principe de Asturias; Servicio de Oncologia

Alcalá de Henares, Madrid, 28805, Spain

Location

Fundacion Hospital de Alcorcon; Servicio de Oncologia

Alcorcón, Madrid, 28922, Spain

Location

Hospital del Henares; Servicio de Oncologia

Coslada, Madrid, 28822, Spain

Location

Complejo Hospitalario de Orense; Servicio de Oncologia

Ourense, Orense, 32005, Spain

Location

Hospital Meixoeiro

Vigo, Pontevedra, 36214, Spain

Location

Hospital Univ. Central de Asturias

Oviedo, Principality of Asturias, 33006, Spain

Location

Hospital Universitario de Canarias (HUC)

La Laguna (Tenerife), Tenerife, 38320, Spain

Location

Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia

Santa Cruz de Tenerife, Tenerife, 38010, Spain

Location

Hospital de Sagunto; Servicio de Oncologia

Sagunto, Valencia, 46520, Spain

Location

Hospital Lluis Alcanys; Servicio de Oncologia

Xàtiva, Valencia, 46800, Spain

Location

Hospital de Cruces; Servicio de Oncologia

Barakaldo, Vizcaya, 48903, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

Barcelona, 08041, Spain

Location

Hospital Universitario Reina Sofia; Servicio de Oncologia

Córdoba, 14004, Spain

Location

Hospital Universitario San Cecilio; Servicio de Oncologia

Granada, 18003, Spain

Location

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

Jaén, 23007, Spain

Location

Complejo Asistencial Universitario de Leon; Servicio de Oncologia

León, 24071, Spain

Location

Complejo Hospitalario Xeral-Cies

Lugo, 27004, Spain

Location

Hospital Universitario La Paz; Servicio de Oncologia

Madrid, 28046, Spain

Location

Hospital Universitario Puerta de Hierro; Servicio de Oncologia

Madrid, 28222, Spain

Location

Hospital Universitario de Mostoles;Servicio de Oncologia

Madrid, 28935, Spain

Location

Hospital Clinico Universitario Virgen de la Victoria; Servicio de Hematologia

Málaga, 29010, Spain

Location

Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

Murcia, 30120, Spain

Location

Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

Salamanca, 37007, Spain

Location

Hospital General de Segovia; Servicio de Oncologia

Segovia, 40002, Spain

Location

Hospital Universitario Virgen Macarena; Servicio de Oncologia

Seville, 41009, Spain

Location

Hospital General de Teruel Obispo Polanco; Servicio Oncologia

Teruel, 44002, Spain

Location

Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

Valencia, 46015, Spain

Location

Hospital Universitario Dr. Peset; Servicio de Oncologia

Valencia, 46017, Spain

Location

Hospital Clinico Universitario de Valladolid; Servicio de Oncologia

Valladolid, 47005, Spain

Location

Complejo Hospitalario Zamora- H. Virgen de la Concha; Servicio Oncologia

Zamora, 49021, Spain

Location

Hospital Universitario Miguel Servet; Servicio Oncologia

Zaragoza, 50009, Spain

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2012
• First Posted: November 8, 2012
• Study Start: December 30, 2013
• Primary Completion: June 20, 2017
• Study Completion: June 20, 2017
• Last Updated: September 11, 2017

Record last verified: 2017-09

Locations

ES (43)