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Observational, multicenter, one-arm, non-comparative study. Data will be recorded in a retrospectively manner. The study will be based on secondary data collected from patient clinical chart completed by the doctor during routine visits. The primary objective is describe the antitumor immune response generated in the context of IO (immunotherapy) treatment after cCRT in patients with unresectable NSCLC treated in real world.
The study is based on the collection of blood samples and tumor sample analysis, in real world NSCLC stage IIIA/B and IIIC; PD-L1>1%; non-resectable patients on treatment with IO after cCRT without progression. The patients participating in this study will not receive treatment in relation to the study, no drugs will be provided. Patients will be treated as per standard clinical practice. All data collected for this study will be collected retrospectively from patient clinical chart. Only secondary data collected will be analyzed together will samples analysis information.The duration of the study is expected to be 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational Study Group | Real world non-small cell lung cancer (NSCLC) stage IIIA/B and IIIC; PD-L1>1%; non-resectable patients in treatment with IO after concurrent chemo-radiotherapy without progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durvalumab | Drug | Chemo-radiotherapy + Durvalumab for non-resectable stage III NSCLC patients according to clinical practice of each participant hospital |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Defined from the date of diagnosis to death from any cause. Patients alive at the end of follow-up or lost to follow-up are censored at the last contact time. The probability of remaining free of events at specific timepoints | To evaluate the Overall Survival at 12, 18, 24 and 36 months |
| Progression-free survival (PFS) | Defined from the diagnosis date to the date of investigator-determined disease relapse or death, whichever occurs first. The probability of remaining free of events at specific timepoints | To evaluate the Progression-free survival at 12, 18, 24 and 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Association between ctDNA clearance (no detection of ctDNA) after IO treatment and Progression free survival (PFS) or Overall survival (OS). | Association between the baseline ctDNA and ctDNA clearance with each one of the OS or PFS | From date of end of treatment until the date of last follow up, assessed up to 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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Real world non-small cell lung cancer (NSCLC) stage IIIA/B and IIIC; PD-L1>1%; non-resectable patients in treatment with IO after concurrent chemo-radiotherapy without progression.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eva Pereira | Contact | +34934302006 | gecp@gecp.org |
| Name | Affiliation | Role |
|---|---|---|
| Mariano Provencio, MD | Fundación GECP President | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario Del Ferrol | Recruiting | Ferrol | A Coruña | 15405 | Spain |
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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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Archival tumor samples Routine Blood samples extraction
|
| Hospital General Universitario de Alicante | Recruiting | Alicante | Alicante | 03010 | Spain |
|
| ICO Badalona, Hospital Germans Trias i Pujol | Recruiting | Badalona | Barcelona | 08916 | Spain |
|
| Hospital Universitari Vall d' Hebron | Recruiting | Barcelona | Barcelona | 08035 | Spain |
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| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | Barcelona | 08041 | Spain |
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| Hospital De Basurto | Recruiting | Bilbao | Bilbao | 48013 | Spain |
|
| Hospital General Universitario de Ciudad Real | Recruiting | Ciudad Real | Ciudad Real | 13005 | Spain |
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| ICO Girona, Hospital Josep Trueta | Recruiting | Girona | Girona | 17007 | Spain |
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| Hospitalario Universitario A Coruña | Recruiting | A Coruña | La Coruña | 15006 | Spain |
|
| Hospital Universitari de Gran Canària Doctor Negrín | Recruiting | Las Palmas de Gran Canaria | Las Palmas | 35010 | Spain |
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| Hospital Universitario Lucus Augusti | Recruiting | Lugo | Lugo | 27003 | Spain |
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| Hospital Universitario De La Princesa | Recruiting | Madrid | Madrid | 28006 | Spain |
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| Hospital Clínico San Carlos | Recruiting | Madrid | Madrid | 28040 | Spain |
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| Hospital Universitario Fundación Jiménez Díaz | Recruiting | Madrid | Madrid | 28040 | Spain |
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| Hospital Universitario La Paz | Recruiting | Madrid | Madrid | 28046 | Spain |
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| Hospital Universitario Puerta de Hierro | Recruiting | Majadahonda | Madrid | 28222 | Spain |
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| Hospital Universitario Central De Asturias | Recruiting | Oviedo | Oviedo | 33011 | Spain |
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| Hospital Universitario Nuestra Señora de Candelaria | Recruiting | Santa Cruz de Tenerife | Santa Cruz de Tenerife | 38010 | Spain |
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| Hospital Virgen del Rocio | Recruiting | Seville | Sevilla | 41013 | Spain |
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| Hospital Universitario Y Politécnico La Fe | Recruiting | Valencia | Valencia | 46026 | Spain |
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| Hospital Clínico Universitario de Valladolid | Recruiting | Valladolid | Valladolid | 47003 | Spain |
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| Complexo Hospitalario Universitario De Vigo | Recruiting | Vigo | Vigo | 36204 | 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 |
|---|---|
| C000613593 | durvalumab |
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