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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03790397

Acronym

OSIREX

Enrollment

169

Registered

2018-12-31

Start date

2019-02-26

Completion date

2020-04-01

Last updated

2022-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Keywords

Lung Cancer, EGFR positive, NSCLC, Osimertinib

Brief 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.

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.

Interventions

DRUGOsimertinib

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Progression free survival	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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026