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NCT03790397 Clinical Trial

Osimertinib in Subjects With Advanced Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive

Non Small Cell Lung Cancer Clinical Trial

— OSIREX  

Official title:
A Retrospective, Multicenter and Observational Study of Osimertinib Monotherapy Treatment in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive Who Have Received the Treatment Within the Special Use Medication Program in Spain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03790397
Other study ID # GECP 18/01_OSIREX
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 26, 2019
Est. completion date April 1, 2020

Study information
Verified date June 2022
Source Fundación GECP
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a retrospective, multicenter and observational study of Osimertinib monotherapy treatment in Subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) EGFR-T790M mutation-positive who have received the treatment within the Special Use Medication Program (SUMP) in Spain.

Description:

The study is based on the collection of data about the patients treated with Osimertinib within the Special Use medication Program. the patienes participating in this non-interventional study will not receive treatment in relation to the study. Approximately a total of 270 patients will be included in this project from several Spanish sites. Around 52 hospitals will participate in the study. the observation period is from August 2016 to December 2018 and will include patients who started the treatment with Osimertininb from August 2016 to April 2018. The primary objective is to estimate the progression free survival of the Osimertinib treatment.

Recruitment information / eligibility
Status Completed
Enrollment 169
Est. completion date April 1, 2020
Est. primary completion date July 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Squamous or Non-Squamous, non-small cell lung cancer (NSCLC), Stage IIIb/IV (histologically or cytologically confirmed), EGFRm/T790M, who received osimertinib treatment within the Spanish special use medication program of Osimertinib (SUMP). - Alive patients must have signed, dated and IRB/EC-approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care. Exclusion Criteria: - Alive patients who do not want to sign and date an IRB/IEC-approved written informed consent form. - Patients who were accepted in the SUMP, but did not receive treatment.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Osimertinib
Patients treated with Osimertinib within the Special Use medication Program (SUMP).

Locations
Country Name City State
Spain Complejo Hospitalario Universitario A Coruña A Coruña La Coruña
Spain Hospital General de Albacete Albacete
Spain Hospital Príncipe de Asturias Alcalá De Henares Madrid
Spain Hospital General Universitario Alicante Alicante
Spain ICO Badalona Badalona Barcelona
Spain Hospital de Sant Pau Barcelona
Spain Hospital Universitario de Burgos Burgos
Spain Hospital Universitario de Getafe Getafe Madrid
Spain Hospital Dr. Josep Trueta Girona
Spain Hospital Universitario de Guadalajara Guadalajara
Spain Complejo Hospitalario de Jaén Jaén
Spain Hospital Universitario Dr. Negrín Las Palmas De Gran Canaria Las Palmas
Spain Complejo Asistencial Universitario de León León
Spain Hospital Universitario Lucus Augusti Lugo
Spain Hospital Clínico San Carlos Madrid
Spain Hospital Ramón y Cajal Madrid
Spain Hospital Universitario Puerta de Hierro Madrid
Spain Hospital General Universitario de Málaga Málaga
Spain Hospital Universitario Central de Asturias Oviedo Asturias
Spain Hospital Universitari Son Espases Palma de Mallorca Mallorca
Spain Hospital Universitario Son Llàtzer Palma De Mallorca Mallorca
Spain Hospital Clínico de Salamanca Salamanca
Spain Hospital Clínico Universitario de Santiago Santiago De Compostela Galicia
Spain Hospital Virgen del Rocío Sevilla
Spain Hospital Virgen de la Salud Toledo
Spain Hospital General Universitario de Valencia Valencia
Spain Hospital Universitari i Politécnic La Fe Valencia
Spain Hospital Clínico Universitario de Valladolid Valladolid
Spain Complejo Hospitalario Universitario de Vigo Vigo Pontevedra
Spain Hospital Lluís Alcanyís Xàtiva Valencia
Spain Hospital Clínico Lozano Blesa Zaragoza

Sponsors (1)
Lead Sponsor Collaborator
Fundación GECP

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression free survival To estimate the progression free survival of the Osimertinib Treatment From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
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