Osimertinib in Subjects With Advanced Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive (OSIREX)
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|ClinicalTrials.gov Identifier: NCT03790397|
Recruitment Status : Completed
First Posted : December 31, 2018
Last Update Posted : April 8, 2020
|Condition or disease||Intervention/treatment|
|Non Small Cell Lung Cancer||Drug: Osimertinib|
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|
|Actual Enrollment :||169 participants|
|Official Title:||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|
|Actual Study Start Date :||February 26, 2019|
|Actual Primary Completion Date :||July 15, 2019|
|Actual Study Completion Date :||April 1, 2020|
- Drug: Osimertinib
Patients treated with Osimertinib within the Special Use medication Program (SUMP).Other Name: Tecentriq
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03790397
|Principal Investigator:||Mariano Provencio, MD||Hospital Universitario Puerta de Hierro|