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

NCT ID: NCT01723878

Last Updated: 2017-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

144 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-30

Study Completion Date

2017-06-20

Brief Summary

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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

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Conditions

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Non-Squamous Non-Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Hospital Virgen de los Lirios; Servicio de Oncologia

Alcoy, Alicante, Spain

Site Status

Hospital Universitario Son Espases; Servicio de Oncologia

Palma de Mallorca, Balearic Islands, Spain

Site Status

Hospital Son Llatzer; Servicio de Oncologia

Palma de Mallorca, Balearic Islands, Spain

Site Status

Hospital General de Granollers; Servicio de Oncologia

Granollers, Barcelona, Spain

Site Status

Hospital Mutua de Terrassa; Servicio de Oncologia

Terrassa, Barcelona, Spain

Site Status

Hospital Universitario Puerta del Mar; Servicio de Oncologia

Cadiz, Cadiz, Spain

Site Status

Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

Santander, Cantabria, Spain

Site Status

Hospital de Donostia; Servicio de Oncologia Medica

Donostia / San Sebastian, Guipuzcoa, Spain

Site Status

Hospital Infanta Sofia; Servico de Oncologia

San Sebastián de los Reyes, Guipuzcoa, Spain

Site Status

Hospital General de Lanzarote

Lanzarote, Las Palmas, Spain

Site Status

Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia

Las Palmas de Gran Canaria, Las Palmas, Spain

Site Status

Hospital Universitario Principe de Asturias; Servicio de Oncologia

Alcalá de Henares, Madrid, Spain

Site Status

Fundacion Hospital de Alcorcon; Servicio de Oncologia

Alcorcón, Madrid, Spain

Site Status

Hospital del Henares; Servicio de Oncologia

Coslada, Madrid, Spain

Site Status

Complejo Hospitalario de Orense; Servicio de Oncologia

Ourense, Orense, Spain

Site Status

Hospital Meixoeiro

Vigo, Pontevedra, Spain

Site Status

Hospital Univ. Central de Asturias

Oviedo, Principality of Asturias, Spain

Site Status

Hospital Universitario de Canarias (HUC)

La Laguna (Tenerife), Tenerife, Spain

Site Status

Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia

Santa Cruz de Tenerife, Tenerife, Spain

Site Status

Hospital de Sagunto; Servicio de Oncologia

Sagunto, Valencia, Spain

Site Status

Hospital Lluis Alcanys; Servicio de Oncologia

Xàtiva, Valencia, Spain

Site Status

Hospital de Cruces; Servicio de Oncologia

Barakaldo, Vizcaya, Spain

Site Status

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status

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

Barcelona, , Spain

Site Status

Hospital Universitario Reina Sofia; Servicio de Oncologia

Córdoba, , Spain

Site Status

Hospital Universitario San Cecilio; Servicio de Oncologia

Granada, , Spain

Site Status

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

Jaén, , Spain

Site Status

Complejo Asistencial Universitario de Leon; Servicio de Oncologia

León, , Spain

Site Status

Complejo Hospitalario Xeral-Cies

Lugo, , Spain

Site Status

Hospital Universitario La Paz; Servicio de Oncologia

Madrid, , Spain

Site Status

Hospital Universitario Puerta de Hierro; Servicio de Oncologia

Madrid, , Spain

Site Status

Hospital Universitario de Mostoles;Servicio de Oncologia

Madrid, , Spain

Site Status

Hospital Clinico Universitario Virgen de la Victoria; Servicio de Hematologia

Málaga, , Spain

Site Status

Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

Murcia, , Spain

Site Status

Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

Salamanca, , Spain

Site Status

Hospital General de Segovia; Servicio de Oncologia

Segovia, , Spain

Site Status

Hospital Universitario Virgen Macarena; Servicio de Oncologia

Seville, , Spain

Site Status

Hospital General de Teruel Obispo Polanco; Servicio Oncologia

Teruel, , Spain

Site Status

Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

Valencia, , Spain

Site Status

Hospital Universitario Dr. Peset; Servicio de Oncologia

Valencia, , Spain

Site Status

Hospital Clinico Universitario de Valladolid; Servicio de Oncologia

Valladolid, , Spain

Site Status

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

Zamora, , Spain

Site Status

Hospital Universitario Miguel Servet; Servicio Oncologia

Zaragoza, , Spain

Site Status

Countries

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Spain

Other Identifiers

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ML28361

Identifier Type: -

Identifier Source: org_study_id

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