NCT03132493

Nivolumab in the Real World: Analysis of the Expanded Use in Spanish Patient

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 676 (actual)
• Sponsor: Spanish Lung Cancer Group · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab 10 MG/ML	nivolumab 3 mg/kg as an intravenous infusion every 2 weeks until progression

Timeline

• Start date: 2017-06-01
• Primary completion: 2017-12-01
• Completion: 2018-09-15
• First posted: 2017-04-27
• Last updated: 2018-11-14

Locations

61 sites across 1 country: Spain