Status:
COMPLETED
Osimertinib in Subjects With Advanced Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive
Lead Sponsor:
Fundación GECP
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
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-positiv...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 26 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT03790397
Start Date
February 26 2019
End Date
April 1 2020
Last Update
June 3 2022
Active Locations (31)
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1
ICO Badalona
Badalona, Barcelona, Spain, 08916
2
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Galicia, Spain, 15706
3
Complejo Hospitalario Universitario A Coruña
A Coruña, La Coruña, Spain, 15006
4
Hospital Universitario Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas, Spain, 35010