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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01723878
First Posted: November 8, 2012
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition
Non-Squamous Non-Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Objective response rate, tumor assessments according to RECIST v1.1 criteria [ Time Frame: 3 years ]
  • One-year overall survival (from initiation of treatment to 12 months after disease progression) [ Time Frame: 3 years ]
  • Time to progression [ Time Frame: 3 years ]
  • Exposure (dosage/duration) with first-line Tarceva in clinical practice [ Time Frame: 3 years ]
  • Safety: Incidence of adverse events [ Time Frame: 3 years ]
  • Velocity of progression (disease flares) after cessation of treatment with Tarceva following disease progression [ Time Frame: 3 years ]
  • Treatments used after disease progression in clinical practice [ Time Frame: 3 years ]

Enrollment: 144
Actual Study Start Date: December 30, 2013
Study Completion Date: June 20, 2017
Primary Completion Date: June 20, 2017 (Final data collection date for primary outcome measure)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723878


Locations
Spain
Hospital Virgen de los Lirios; Servicio de Oncologia
Alcoy, Alicante, Spain, 03804
Hospital Univ. Central de Asturias
Oviedo, Asturias, Spain, 33006
Hospital General de Granollers; Servicio de Oncologia
Granollers, Barcelona, Spain, 08400
Hospital Mutua de Terrassa; Servicio de Oncologia
Terrassa, Barcelona, Spain, 08221
Hospital Universitario Puerta del Mar; Servicio de Oncologia
Cádiz, Cadiz, Spain, 11009
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
Santander, Cantabria, Spain, 39008
Hospital Infanta Sofia; Servico de Oncologia
San Sebastian de Los Reyes, Guipuzcoa, Spain, 28702
Hospital de Donostia; Servicio de Oncologia Medica
San Sebastian, Guipuzcoa, Spain, 20080
Hospital Universitario Son Espases; Servicio de Oncologia
Palma De Mallorca, Islas Baleares, Spain, 07014
Hospital Son Llatzer; Servicio de Oncologia
Palma de Mallorca, Islas Baleares, Spain, 07198
Hospital General de Lanzarote
Lanzarote, Las Palmas, Spain
Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia
Las Palmas de Gran Canaria, Las Palmas, Spain, 35020
Hospital Universitario Principe de Asturias; Servicio de Oncologia
Alcala de Henares, Madrid, Spain, 28805
Fundacion Hospital de Alcorcon; Servicio de Oncologia
Alcorcon, Madrid, Spain, 28922
Hospital del Henares; Servicio de Oncologia
Coslada, Madrid, Spain, 28822
Hospital Meixoeiro
Vigo, Pontevedra, Spain, 36214
Hospital Universitario de Canarias (HUC)
La Laguna (Tenerife), Tenerife, Spain, 38320
Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia
Santa Cruz de Tenerife, Tenerife, Spain, 38010
Hospital de Sagunto; Servicio de Oncologia
Sagunto, Valencia, Spain, 46520
Hospital Lluis Alcanys; Servicio de Oncologia
Xativa, Valencia, Spain, 46800
Hospital de Cruces; Servicio de Oncologia
Barakaldo, Vizcaya, Spain, 48903
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona, Spain, 08041
Hospital Universitario Reina Sofia; Servicio de Oncologia
Cordoba, Spain, 14004
Hospital Universitario San Cecilio; Servicio de Oncologia
Granada, Spain, 18003
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
Jaen, Spain, 23007
Complejo Asistencial Universitario de Leon; Servicio de Oncologia
Leon, Spain, 24071
Complejo Hospitalario Xeral-Cies
Lugo, Spain, 27004
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, Spain, 28046
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
Madrid, Spain, 28222
Hospital Universitario de Mostoles;Servicio de Oncologia
Madrid, Spain, 28935
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Hematologia
Malaga, Spain, 29010
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
Murcia, Spain, 30120
Complejo Hospitalario de Orense; Servicio de Oncologia
Orense, Spain, 32005
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
Salamanca, Spain, 37007
Hospital General de Segovia; Servicio de Oncologia
Segovia, Spain, 40002
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Sevilla, Spain, 41009
Hospital General de Teruel Obispo Polanco; Servicio Oncologia
Teruel, Spain, 44002
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
Valencia, Spain, 46015
Hospital Universitario Dr. Peset; Servicio de Oncologia
Valencia, Spain, 46017
Hospital Clinico Universitario de Valladolid; Servicio de Oncologia
Valladolid, Spain, 47005
Complejo Hospitalario Zamora- H. Virgen de la Concha; Servicio Oncologia
Zamora, Spain, 49021
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, Spain, 50009
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01723878     History of Changes
Other Study ID Numbers: ML28361
First Submitted: November 6, 2012
First Posted: November 8, 2012
Last Update Posted: September 11, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action