Spanish Real World Data on Patients Treated With Durvalumab After Chemoradiotherapy.
- Registration Number
- NCT04285866
- Lead Sponsor
- Fundación GECP
- 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.
- Detailed Description
Lung Cancer represent approximately 13% of total cancer diagnoses worldwide and continues to be the leading cause of cancer-related mortality. Stage III represents between 25-30% of NSCLC and the majority of them are unresectable. The standard treatment in unresectable patients was chemoradiotherapy consurrently if possible.
The PACIFIC study is a phase III study to evaluate the efficacy and safety of durvalumab as a sequential therapy concurrent platinum-based chemotherapy and thoracic RT. The study was positive for both primary endpoints progression-free survival and overall survival. After that, it was decided to open an early acces programme ti provide acces to durvalumab for patients with locally advanced, unresectable NSCLC (stage III) tho have not progressed following chemoradiation.
This observational study is based on the collection of data about the patients treated with Durvalumab after chemoraditherapy in the real world.
The study will include all 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.
The primary objective is to assess affectiveness of durvalumab in patients treated in real-life settings by evaluating Progression Free Survival. Other secondary objectives are:
To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating 1-year survival rate, to describe adverse events of special interests, to stimate time and sites of disease progression or relapse in metastatic setting, to describe details on durvalumab treatment, to describe demographic and clinical characteristics of stage III unresectable NSCLC patients treated with Durvalumab, to describe previous chemoradiotherapy strategy, to describe the baseline staging status, to further assess subsequent treatments pattern at the time of disease progression including duration of therapy and type of therapy, and to explore healthcare resource utilization while on durvalumab treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 245
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Durvalumab Group Durvalumab 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.
- Primary Outcome Measures
Name Time Method Progression Free Survival (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 To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating PFS
- Secondary Outcome Measures
Name Time Method 1-year survival rate 1 year To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating 1-year survival rate.
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 To estimate time and sites of disease progression or relapse in metastatic setting.
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 To describe AESIs leading to treatment temporary interruption or permanent discontinuation of durvalumab, or which require interventions of concomitant use of corticosteroids, immunosupressants and/or endocrine therapies.
Trial Locations
- Locations (39)
Hospital General de Alicante
🇪🇸Alicante, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Cataluña, Spain
Hospital Universitario Reina Sofía
🇪🇸Córdoba, Spain
Hospital Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital Universitario Fundación Alcorcón
🇪🇸Alcorcón, Madrid, Spain
Hospital Universitario Son Llàtzer
🇪🇸Palma De Mallorca, Illes Balears, Spain
Hospital Universitario Clínico San Cecilio
🇪🇸Granada, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Hospital Universitario Infanta Sofía
🇪🇸Madrid, Spain
Hospital La Princesa
🇪🇸Madrid, Spain
Hospital de Sanchinarro
🇪🇸Madrid, Spain
Hospital Universitario de Basurto
🇪🇸Bilbao, Vizcaya, Spain
Hospital Clínico Universitario de Valladolid
🇪🇸Valladolid, Spain
Hospital Universitario de Donostia
🇪🇸Donostia, País Vasco, Spain
Clínica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain
Consorci Mar Parc de Salut de Barcelona
🇪🇸Barcelona, Spain
Hospital de A Coruña
🇪🇸A Coruña, Spain
Hospital Universitario de Guadalajara
🇪🇸Guadalajara, Spain
Hospital Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital Universitario Insular de Gran canaria
🇪🇸Las Palmas De Gran Canaria, Gran Canaria, Spain
Hospital Nuestra Señora de Candelaria
🇪🇸Santa Cruz de Tenerife, Tenerife, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario De La Ribera
🇪🇸Alzira, Valencia, Spain
Hospital General de Granollers
🇪🇸Granollers, Barcelona, Spain
Corporació Sanitaria Parc Taulí
🇪🇸Sabadell, Barcelona, Spain
Hospital Costa del Sol
🇪🇸Marbella, Málaga, Spain
Hospital Clínico Universitario de Santiago
🇪🇸Santiago De Compostela, A Coruña, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Complejo Hospitalario de Jaén
🇪🇸Jaén, Spain
Hospital Universitario Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital Clínico Universitario de Salamanca
🇪🇸Salamanca, Spain
Complexo Hospitalario de Ourense
🇪🇸Ourense, Spain
Hospital General de Segovia
🇪🇸Segovia, Spain
Hospital Clínico Lozano Blesa
🇪🇸Zaragoza, Spain
Hospital Universitari i Politécnic La Fe
🇪🇸Valencia, Spain
Hospital Virgen de la Salud
🇪🇸Toledo, Spain