Nivolumab in the Real World: Analysis of the Expanded Use in Spanish Patient (NIVEX)
We will 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.
|Study Design:||Observational Model: Other
Time Perspective: Retrospective
|Official Title:||A Retrospective, Multicenter and Observational Study of Nivolumab Monotherapy Treatment in Subjects With Advanced or Metastatic Squamous (Sq) or Non-Squamous (Non-Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimens for the Treatment of Stage IIIb/IV NSCLC Within the Expanded Access Program (EAP) in SPAIN|
- Progression Free survival [ Time Frame: At 12 months ]time from inclusion to progression
- Overall Response rate [ Time Frame: At 12 months ]Percentage of patient reaching a complete, partial or stable disease
|Anticipated Study Start Date:||June 2017|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Drug: Nivolumab 10 MG/ML
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03132493
|H. Germans Trias i Pujol||Not yet recruiting|
|Badalona, Barcelona, Spain, 08916|
|Contact: Enric Carcereny, MD + 34 93 430 20 06 firstname.lastname@example.org|
|Principal Investigator: Enric Carcereny, MD|
|Consorci Sanitari de Terrassa||Not yet recruiting|
|Terrassa, Barcelona, Spain, 08220|
|Contact: Remei Blanco, MD-PhD +34 93 430 20 06 email@example.com|
|Principal Investigator: Remei Blanco, MD-PhD|
|Hospital Insular de Gran Canaria||Not yet recruiting|
|Las Palmas de Gran Canaria, Las Palmas, Spain|
|Contact: Delvys Rodríguez, MD +34 93 430 20 06 firstname.lastname@example.org|
|Principal Investigator: Delvys Rodríguez, MD|
|Hospital de Sant Pau Y de La Santa Creu||Not yet recruiting|
|Barcelona, Spain, 08036|
|Contact: Margarita Majem, MD +34 93 430 20 06 MMajem@santpau.cat|
|Principal Investigator: Margarita Majem, MD|