Osimertinib in Subjects With Advanced Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive
OSIREX
A Retrospective, Multicenter and Observational Study of Osimertinib Monotherapy Treatment in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive Who Have Received the Treatment Within the Special Use Medication Program in Spain
1 other identifier
observational
169
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2019
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 24, 2018
CompletedFirst Posted
Study publicly available on registry
December 31, 2018
CompletedStudy Start
First participant enrolled
February 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedJune 3, 2022
June 1, 2022
5 months
December 24, 2018
June 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
Patients treated with Osimertinib within the Special Use medication Program (SUMP).
Eligibility Criteria
All patients who have received Osimertinib in the SUMP in Spain.
You may qualify 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 qualify 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundación GECPlead
Study Sites (31)
ICO Badalona
Badalona, Barcelona, 08916, Spain
Hospital Clínico Universitario de Santiago
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
Related Publications (1)
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.
PMID: 33676426DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mariano Provencio, MD
Hospital Universitario Puerta de Hierro
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2018
First Posted
December 31, 2018
Study Start
February 26, 2019
Primary Completion
July 15, 2019
Study Completion
April 1, 2020
Last Updated
June 3, 2022
Record last verified: 2022-06