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

June 1, 2022 updated by: Fundación GECP

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

169

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Albacete, Spain, 02006
        • Hospital General de Albacete
      • Alicante, Spain, 03010
        • Hospital General Universitario Alicante
      • Barcelona, Spain, 08041
        • Hospital de Sant Pau
      • Burgos, Spain, 09006
        • Hospital Universitario de Burgos
      • Girona, Spain, 17007
        • Hospital Dr. Josep Trueta
      • Guadalajara, Spain, 19002
        • Hospital Universitario de Guadalajara
      • Jaén, Spain, 23007
        • Complejo Hospitalario de Jaén
      • León, Spain, 24071
        • Complejo Asistencial Universitario de León
      • Lugo, Spain, 27003
        • Hospital Universitario Lucus Augusti
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro
      • Málaga, Spain, 29010
        • Hospital General Universitario de Málaga
      • Salamanca, Spain, 37007
        • Hospital Clinico De Salamanca
      • Sevilla, Spain, 41013
        • Hospital Virgen del Rocío
      • Toledo, Spain, 45071
        • Hospital Virgen De La Salud
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
      • Valencia, Spain, 46009
        • Hospital Universitari I Politecnic La Fe
      • Valladolid, Spain, 47003
        • Hospital Clínico Universitario de Valladolid
      • Zaragoza, Spain, 50009
        • Hospital Clinico Lozano Blesa
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Ico Badalona
    • Galicia
      • Santiago De Compostela, Galicia, Spain, 15706
        • Hospital Clinico Universitario de Santiago
    • La Coruña
      • A Coruña, La Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña
    • Las Palmas
      • Las Palmas De Gran Canaria, Las Palmas, Spain, 35010
        • Hospital Universitario Dr. Negrin
    • Madrid
      • Alcalá De Henares, Madrid, Spain, 28805
        • Hospital Principe de Asturias
      • Getafe, Madrid, Spain, 28905
        • Hospital Universitario de Getafe
    • Mallorca
      • Palma De Mallorca, Mallorca, Spain, 07198
        • Hospital Universitario Son Llatzer
      • Palma de Mallorca, Mallorca, Spain, 07120
        • Hospital Universitari Son Espases
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36036
        • Complejo Hospitalario Universitario de Vigo
    • Valencia
      • Xàtiva, Valencia, Spain, 46800
        • Hospital Lluis Alcanyis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients who have received Osimertinib in the SUMP in Spain.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación GECP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 26, 2019

Primary Completion (ACTUAL)

July 15, 2019

Study Completion (ACTUAL)

April 1, 2020

Study Registration Dates

First Submitted

December 24, 2018

First Submitted That Met QC Criteria

December 28, 2018

First Posted (ACTUAL)

December 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 3, 2022

Last Update Submitted That Met QC Criteria

June 1, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GECP 18/01_OSIREX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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