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

Completed

• 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

Study Timeline

• Study First Submitted: 2012-11-06
• Study First Submitted QC: 2012-11-06
• Study First Posted: 2012-11-08
• Study Start: 2013-12-30
• Primary Completion: 2017-06-20
• Study Completion: 2017-06-20
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-08
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

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 Virgen de los Lirios; Servicio de Oncologia; 🇪🇸 Alcoy, Alicante, Spain

Hospital Univ. Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

Hospital General de Granollers; Servicio de Oncologia; 🇪🇸 Granollers, Barcelona, Spain

Hospital Mutua de Terrassa; Servicio de Oncologia; 🇪🇸 Terrassa, Barcelona, Spain

Hospital Universitario Puerta del Mar; Servicio de Oncologia; 🇪🇸 Cádiz, Cadiz, Spain

Hospital Universitario Marques de Valdecilla; Servicio de Oncologia; 🇪🇸 Santander, Cantabria, Spain

Hospital Infanta Sofia; Servico de Oncologia; 🇪🇸 San Sebastian de Los Reyes, Guipuzcoa, Spain

Hospital de Donostia; Servicio de Oncologia Medica; 🇪🇸 San Sebastian, Guipuzcoa, 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

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