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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osimertinib | Drug | Patients treated with Osimertinib within the Special Use medication Program (SUMP). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | To estimate the progression free survival of the Osimertinib Treatment | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who have received Osimertinib in the SUMP in Spain.
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| Name | Affiliation | Role |
|---|---|---|
| Mariano Provencio, MD | Hospital Universitario Puerta de Hierro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICO Badalona | Badalona | Barcelona | 08916 | Spain | ||
| Hospital Clínico Universitario de Santiago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33676426 | Derived | Provencio M, Terrasa J, Garrido P, Campelo RG, Aparisi F, Diz P, Aguiar D, Garcia-Giron C, Hidalgo J, Aguado C, Gonzalez JG, Esteban E, Gomez-Aldavari L, Moran T, Juan O, Chara LE, Marti JL, Castro RL, Ortega AL, Moreno EM, Coves J, Sanchez Pena AM, Bosch-Barrera J, Gastaldo AS, Nunez NF, Del Barco E, Cobo M, Isla D, Majem M, Navarro F, Calvo V. Osimertinib in advanced EGFR-T790M mutation-positive non-small cell lung cancer patients treated within the Special Use Medication Program in Spain: OSIREX-Spanish Lung Cancer Group. BMC Cancer. 2021 Mar 6;21(1):230. doi: 10.1186/s12885-021-07922-5. |
| Label | URL |
|---|---|
| Web page of the sponsor where users can find more information about Fundación GECP studies | View source |
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| Santiago de Compostela |
| Galicia |
| 15706 |
| Spain |
| Complejo Hospitalario Universitario A Coruña | A Coruña | La Coruña | 15006 | Spain |
| Hospital Universitario Dr. Negrín | Las Palmas de Gran Canaria | Las Palmas | 35010 | Spain |
| Hospital Príncipe de Asturias | Alcalá de Henares | Madrid | 28805 | Spain |
| Hospital Universitario de Getafe | Getafe | Madrid | 28905 | Spain |
| Hospital Universitari Son Espases | Palma de Mallorca | Mallorca | 07120 | Spain |
| Hospital Universitario Son Llàtzer | Palma de Mallorca | Mallorca | 07198 | Spain |
| Complejo Hospitalario Universitario de Vigo | Vigo | Pontevedra | 36036 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital Lluís Alcanyís | Xàtiva | Valencia | 46800 | Spain |
| Hospital General de Albacete | Albacete | 02006 | Spain |
| Hospital General Universitario Alicante | Alicante | 03010 | Spain |
| Hospital de Sant Pau | Barcelona | 08041 | Spain |
| Hospital Universitario de Burgos | Burgos | 09006 | Spain |
| Hospital Dr. Josep Trueta | Girona | 17007 | Spain |
| Hospital Universitario de Guadalajara | Guadalajara | 19002 | Spain |
| Complejo Hospitalario de Jaén | Jaén | 23007 | Spain |
| Complejo Asistencial Universitario de León | León | 24071 | Spain |
| Hospital Universitario Lucus Augusti | Lugo | 27003 | Spain |
| Hospital Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario Puerta de Hierro | Madrid | 28222 | Spain |
| Hospital General Universitario de Málaga | Málaga | 29010 | Spain |
| Hospital Clínico de Salamanca | Salamanca | 37007 | Spain |
| Hospital Virgen del Rocío | Seville | 41013 | Spain |
| Hospital Virgen de la Salud | Toledo | 45071 | Spain |
| Hospital Universitari i Politécnic La Fe | Valencia | 46009 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Hospital Clínico Universitario de Valladolid | Valladolid | 47003 | Spain |
| Hospital Clínico Lozano Blesa | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000596361 | osimertinib |
| C000594389 | atezolizumab |
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