Spanish Real World Data on Patients Treated With Durvalumab After Chemoradiotherapy.
S-REAL
Spanish Real World Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy.
1 other identifier
observational
245
1 country
39
Brief Summary
This is a non-interventional, observational, multicentre, one-arm, non-comparative, and retrospective study. The study is based on the collection of data about the patients treated with Durvalumab after chemoraditherapy in the real world. The patients participating in this non-interventional study will not receive treatment in relation to the study. The primary objective is to assess affectiveness of durvalumab in patients treated in real-life settings by evaluating Progression Free Survival.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
39 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
February 24, 2020
CompletedFirst Posted
Study publicly available on registry
February 26, 2020
CompletedStudy Start
First participant enrolled
May 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJune 7, 2022
June 1, 2022
1.6 years
February 24, 2020
June 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating PFS
From date of the first dose of durvalumab received (within the EAP) to the date of disease progression, death, or the end of follow-up, assessed up to 60 months
Secondary Outcomes (3)
1-year survival rate
1 year
To describe adverse events of special interest (AESIs)
From date of the first dose of durvalumab received (within the EAP) to the date of disease progression, death, or the end of follow-up, assessed up to 60 months
Time and site of disease progression or relapse
From date of the first dose of durvalumab received to the date of disease progression, assessed up to 60 months
Study Arms (1)
Durvalumab Group
Patients who have participated in the EAP between 1 September 2017 up to 21 December 2018 and have received at least 1 dose of durvalumab.
Interventions
Eligibility Criteria
All patients who have parcipated in the EAP between 1 September 2017 up to 21 December 2018 and have received at least 1 dose of durvalumab.
You may qualify if:
- Patients must have histologically or cytologically documented diagnosis of NSCLC with a locally advanced, or locally recurrent, unresectable (stage III) disease (according to American Joint Committee on Cancer \[AJCC\] lung cancer edition 7 or 8).
- Age ≥ 18 years at time of study Entry
- Patients must have been treated with chemotherapy and radiotherapy concurrently or sequentially and shown no progressive disease following chemoradiation
- Patients must have been enrolled in durvalumab EAPs between 1 September 2017 and 21 December 2018.
- Patients must have been treated with at least one dose of durvalumab within the EAP
- 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 EAP, but did not receive treatment.
- Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundación GECPlead
Study Sites (39)
Hospital Clínico Universitario de Santiago
Santiago de Compostela, A Coruña, 15706, Spain
Hospital Universitario Son Llàtzer
Palma de Mallorca, Balearic Islands, 07198, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital General de Granollers
Granollers, Barcelona, 08402, Spain
Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, 08208, Spain
Hospital Universitario de Donostia
Donostia / San Sebastian, Basque Country, 20014, Spain
Hospital Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041, Spain
Hospital Universitario Insular de Gran canaria
Las Palmas de Gran Canaria, Gran Canaria, 35016, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922, Spain
Hospital Costa del Sol
Marbella, Málaga, 29603, Spain
Clínica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Hospital Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Tenerife, 38010, Spain
Hospital Universitario De La Ribera
Alzira, Valencia, 46600, Spain
Hospital Universitario de Basurto
Bilbao, Vizcaya, 48013, Spain
Hospital de A Coruña
A Coruña, 15006, Spain
Hospital General de Alicante
Alicante, 03010, Spain
Consorci Mar Parc de Salut de Barcelona
Barcelona, 08003, Spain
Hospital Universitario Reina Sofía
Córdoba, 14004, Spain
Hospital Universitario Clínico San Cecilio
Granada, 18016, Spain
Hospital Universitario de Guadalajara
Guadalajara, 19002, Spain
Complejo Hospitalario de Jaén
Jaén, 23007, Spain
Hospital La Princesa
Madrid, 28006, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28007, Spain
Hospital Ramón y Cajal
Madrid, 28034, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital de Sanchinarro
Madrid, 28050, Spain
Hospital Universitario Infanta Sofía
Madrid, 28702, Spain
Complexo Hospitalario de Ourense
Ourense, 32005, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, 37007, Spain
Hospital General de Segovia
Segovia, 40002, 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 Clínico Universitario de Valladolid
Valladolid, 47003, Spain
Hospital Clínico Lozano Blesa
Zaragoza, 50009, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Pilar Garrido, MD
Fundación GECP Investigator
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2020
First Posted
February 26, 2020
Study Start
May 21, 2020
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
June 7, 2022
Record last verified: 2022-06