An observational study in Non Small Cell Lung Cancer, sponsored by Spanish Lung Cancer Group. Completed at 61 sites in Spain. Per ClinicalTrials.gov, last updated 2018-11-14.
Sponsored by Spanish Lung Cancer Group · Observational
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 676 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Spanish Lung Cancer Group is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
Exclusion Criteria:
nivolumab 3 mg/kg as an intravenous infusion every 2 weeks until progression
Also known as: Opdivo
Progression Free survival
time from inclusion to progression
Time frame: At 12 months
Overall Response rate
Percentage of patient reaching a complete, partial or stable disease
Time frame: At 12 months
Plan to share: No
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Spanish Lung Cancer Group