Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Fundación GECP
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Osimertinib in Subjects With Advanced Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive