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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durvalumab | Drug | Durvalumab after chemoradiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year survival rate | To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating 1-year survival rate. | 1 year |
| To describe adverse events of special interest (AESIs) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pilar Garrido, MD | Fundación GECP Investigator | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico Universitario de Santiago | Santiago de Compostela | A Coruña | 15706 | Spain | ||
| Hospital Universitario Son Llàtzer |
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| Label | URL |
|---|---|
| Web page of the sponsor where users can find more information about Fundación GECP studies | View source |
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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.
| 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 | To estimate time and sites of disease progression or relapse in metastatic setting. | From date of the first dose of durvalumab received to the date of disease progression, assessed up to 60 months |
| 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 |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| 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 |
|---|---|
| C000613593 | durvalumab |
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