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

Fundación GECP169 enrolled

Overview

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.

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

169

Conditions

Non Small Cell Lung Cancer

Interventions

OsimertinibDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (31)

Outcomes

Primary Outcomes

Progression free survival

To estimate the progression free survival of the Osimertinib Treatment

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

Data from ClinicalTrials.gov

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ICO Badalona

Badalona, Barcelona, Spain

Hospital Clínico Universitario de Santiago

Santiago de Compostela, Galicia, Spain

Complejo Hospitalario Universitario A Coruña

A Coruña, La Coruña, Spain

Hospital Universitario Dr. Negrín

Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital Príncipe de Asturias

Alcalá de Henares, Madrid, Spain

Hospital Universitario de Getafe

Getafe, Madrid, Spain

Hospital Universitari Son Espases

Palma de Mallorca, Mallorca, Spain

Hospital Universitario Son Llàtzer

Palma de Mallorca, Mallorca, Spain

Complejo Hospitalario Universitario de Vigo

Vigo, Pontevedra, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

...and 21 more locations