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The investigators will be retrospectively review the case note of patients registered in the EAP of Nivolumab.
A standard anonymous data collection form will be used to collect data and to analyze it.
Patients with advanced Non-Small Cell Lung Cancer previously treated and included in the SPANISH expanded access programme of nivolumab.
This study will help to understand the efficacy of Nivolumab in the real world setting within the SPANISH expanded access programme.
The main objective of this study is to evaluate nivolumab efficacy in terms of Overall Survival (OS), Progression Free Survival (PFS), Overall Response Rate (ORR) and safety in the clinical practice.
The efficacy variables will be assessed for patients (squamous vs non-squamous) who received second line therapies or third lines and subsequent lines and also, long responders will be evaluated.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab 10 MG/ML | Drug | nivolumab 3 mg/kg as an intravenous infusion every 2 weeks until progression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free survival | time from inclusion to progression | At 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response rate | Percentage of patient reaching a complete, partial or stable disease | At 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients eligible for the trial are those treated in the EAP of nivolumab in Spain. The total number of patients to be included will be 1400 from 150 participating sites in Spain (anticipated data)
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| Name | Affiliation | Role |
|---|---|---|
| Delvys Rodríguez, MD, PhD | Hospital Universitario Insular de Gran Canaria | Principal Investigator |
| Margarita Majem, MD, PhD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Virgen de los Lirios | Alcoy | Alicante | 03804 | Spain | ||
| Hospital de Elche |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Elche |
| Alicante |
| 03202 |
| Spain |
| Hospital Universitario de Vinalopó | Elche | Alicante | 03293 | Spain |
| Hospital General Universitario de Elda | Elda | Alicante | 03600 | Spain |
| H. Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital de Mataró | Mataró | Barcelona | 08304 | Spain |
| Corporació Sanitaria Parc Taulí | Sabadell | Barcelona | 08208 | Spain |
| Consorci Sanitari de Terrassa | Terrassa | Barcelona | 08220 | Spain |
| Hospital Universitari Mútua de Terrassa | Terrassa | Barcelona | 08221 | Spain |
| Hospital de Galdakao | Galdakao | Bizkaia | 48960 | Spain |
| Hospital Universitario de Donostia | Donostia / San Sebastian | Gipuzkoa | 20014 | Spain |
| Centro Oncológico de Galicia | A Coruña | La Coruña | 15009 | Spain |
| Hospital Insular de Gran Canaria | Las Palmas de Gran Canaria | Las Palmas | Spain |
| Hospital Universitario Fundación Alcorcón | Alcorcón | Madrid | 28922 | Spain |
| Hospital Universitario de Fuenlabrada | Fuenlabrada | Madrid | 28942 | Spain |
| Hospital Severo Ochoa | Leganés | Madrid | 28911 | Spain |
| Hospital Universitario de Móstoles | Móstoles | Madrid | 28935 | Spain |
| Hospital Universitario Infanta Cristina | Parla | Madrid | 28981 | Spain |
| Hospital Universitario Quirón Madrid | Pozuelo de Alarcón | Madrid | Madrid | Spain |
| Clínica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| Complejo Hospitalario de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Sant Joan de Reus | Reus | Tarragona | 43204 | Spain |
| Hospital Lluís Alcanyís | Xàtiva | Valencia | 46800 | Spain |
| Hospital de Cruces | Barakaldo | Vizcaya | 48903 | Spain |
| Hospital de Basurto | Bilbao | Vizcaya | 48013 | Spain |
| Hospital Universitario a Coruña | A Coruña | 15006 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Vall d' Hebron | Barcelona | 08035 | Spain |
| H. Universitario Quirón Dexeus | Barcelona | 08036 | Spain |
| Hospital de Sant Pau Y de La Santa Creu | Barcelona | 08036 | Spain |
| H. Althaia | Barcelona | 08243 | Spain |
| Hospital Virgen de la Luz | Cuenca | 16002 | Spain |
| Hospital Dr. Josep Trueta | Girona | 17007 | Spain |
| Hospital Clínico San Cecilio | Granada | 18012 | Spain |
| Hospital 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 General Universitario Gregorio Marañón | Madrid | 28007 | Spain |
| MD Anderson Cancer Center | Madrid | 28033 | Spain |
| H.U. Puerta de Hierro | Madrid | 28035 | Spain |
| Fundación Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario Infanta Sofía | Madrid | 28703 | Spain |
| H. Carlos Haya | Málaga | 29010 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| H. Morales Messeguer | Murcia | 30008 | Spain |
| Hospital Clínico Universitario Virgen de la Arrixaca | Murcia | 30120 | Spain |
| Hospital Son Espases | Palma de Mallorca | 07010 | Spain |
| H. Son Llàtzer | Palma de Mallorca | 07198 | Spain |
| Hospital Clinico de Salamanca | Salamanca | 37007 | Spain |
| Hospital Nuestra Señora Candelaria | Santa Cruz de Tenerife | 38010 | Spain |
| Hospital Virgen del Rocío | Seville | 41013 | Spain |
| Instituto Valenciano de Oncología | Valencia | 46009 | Spain |
| Hospital General de Valencia | Valencia | 46014 | Spain |
| Hospital Dr. Peset | Valencia | 46017 | Spain |
| Hospital de Sagunto | Valencia | 46500 | Spain |
| Hospital La Fe | Valencia | Spain |
| Hospital Clínico Universitario de Valladolid | Valladolid | 47003 | Spain |
| H. Miguel Servet | Zaragoza | 50009 | Spain |
| Hospital Universitario de Áraba | Vitoria-Gasteiz | Áraba | 01009 | Spain |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung 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 |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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