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

Completed

• Conditions: Non Small Cell Lung Cancer

• Registration Number: NCT03790397
• Lead Sponsor: Fundación GECP

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.

Study Timeline

• Study First Submitted: 2018-12-24
• Study First Submitted QC: 2018-12-28
• Study First Posted: 2018-12-31
• Study Start: 2019-02-26
• Primary Completion: 2019-07-15
• Study Completion: 2020-04-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-01
• Last Update Posted: 2022-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (31)

Hospital Universitario Dr. Negrín; 🇪🇸 Las Palmas De Gran Canaria, Las Palmas, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

ICO Badalona; 🇪🇸 Badalona, Barcelona, Spain

Hospital Universitario de Getafe; 🇪🇸 Getafe, Madrid, Spain

Hospital Universitari Son Espases; 🇪🇸 Palma de Mallorca, Mallorca, Spain

Hospital Universitario de Guadalajara; 🇪🇸 Guadalajara, Spain

Hospital Virgen de la Salud; 🇪🇸 Toledo, Spain

Hospital Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital Universitario de Burgos; 🇪🇸 Burgos, Spain

Hospital Clínico Universitario de Santiago; 🇪🇸 Santiago De Compostela, Galicia, Spain

Complejo Hospitalario Universitario A Coruña; 🇪🇸 A Coruña, La Coruña, Spain

Hospital Príncipe de Asturias; 🇪🇸 Alcalá De Henares, Madrid, Spain

Hospital Lluís Alcanyís; 🇪🇸 Xàtiva, Valencia, Spain

Hospital Universitario Son Llàtzer; 🇪🇸 Palma De Mallorca, Mallorca, Spain

Hospital General de Albacete; 🇪🇸 Albacete, Spain

Complejo Hospitalario Universitario de Vigo; 🇪🇸 Vigo, Pontevedra, Spain

Complejo Hospitalario de Jaén; 🇪🇸 Jaén, Spain

Hospital Dr. Josep Trueta; 🇪🇸 Girona, Spain

Hospital General Universitario Alicante; 🇪🇸 Alicante, Spain

Hospital de Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitario Lucus Augusti; 🇪🇸 Lugo, Spain

Complejo Asistencial Universitario de León; 🇪🇸 León, Spain

Hospital Clínico de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Universitario Puerta de Hierro; 🇪🇸 Madrid, Spain

Hospital General Universitario de Málaga; 🇪🇸 Málaga, Spain

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain

Hospital Universitari i Politécnic La Fe; 🇪🇸 Valencia, Spain

Hospital Clínico Lozano Blesa; 🇪🇸 Zaragoza, Spain

Hospital General Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain