Real Life Second-Line Nivolumab in Advanced Non-Small Cell Lung Cancer

Completed

• Conditions: NSCLC

• Registration Number: NCT04858204
• Lead Sponsor: University Hospital, Brest

Brief Summary

Data regarding nivolumab as second line treatment in advanced non-small cell lung cancer (NSCLC) are based on selected populations and might not reflect daily practice. Investigators aimed at assessing efficacy and safety of nivolumab in a real-life setting and determining a subtype of NSCLC patients that are more likely to benefit from immunotherapy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-04
• Study Start: 2017-04-14
• Primary Completion: 2017-10-31
• Study Completion: 2017-11-01
• Study First Submitted: 2018-09-13
• Study First Submitted QC: 2021-04-22
• Last Update Submitted: 2021-04-22
• Study First Posted: 2021-04-26
• Last Update Posted: 2021-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 259

Inclusion Criteria

• advanced NSCLC (stage IIIB-IV)
• failure of at least one line of chemotherapy.
• age ≥18 years,
• initiation of nivolumab between 01/09/2015 and 30/09/2016.

Exclusion Criteria

• nivolumab initiation after October 2016
• prior involvement in an immunotherapy trial
• refusal to participate.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nivolumab Objective response rate	through study completion, an average of 1 year	Objective response rate evaluated by RECIST 1.1

Trial Locations

Locations (7)

CH DINAN; 🇫🇷 Dinan, France

CHRU de Brest; 🇫🇷 Brest, France

CHU de Rennes; 🇫🇷 Rennes, France

Centre hospitalier de Saint Malo; 🇫🇷 Saint-Malo, France

CH de VANNES; 🇫🇷 Vannes, France

Centre Hospitalier Yves Le Foll; 🇫🇷 St BRIEUC, France

Centre Hospitalier de Bretagne Sud; 🇫🇷 Lorient, France