NCT04713462

Real-world Data of Nivolumab in Pre-treated NSCLC

Real-world Data and Economic Evaluation of Nivolumab in Previously Treated NSCLC Patients in Greece

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 346 (actual)
• Sponsor: Hellenic Cooperative Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Nivolumab is an approved treatment option for patients with previously treated advanced NSCLC, based on the survival benefit shown versus docetaxel in randomized phase III trials in second line. However, the profile of treatment and even patient outcomes are often different in routine clinical practice than in a clinical trial setting. Furthermore, the financial impact of an approved therapy is often largely unknown. This study will record the efficacy and tolerability of Nivolumab in previously treated patients with NSCLC and describe the treatment patterns and economic impact in real-world settings in Greece.

Detailed description

Patients with advanced NSCLC who had received nivolumab as 2nd line and beyond, between October 2015 and November 2019, in HeCOG clinical centres in Greece, were enrolled. Information regarding detailed patient and treatment characteristics including post-nivolumab therapies, efficacy, and safety data of nivolumab treatment and additionally data on costs and other economic values are collected, analysed and compared with historical data in order to describe the real-world patterns of Nivolumab use in 2nd line NSCLC therapy in Greece.

Conditions

• Non Small Cell Lung Cancer

Timeline

• Start date: 2015-10-01
• Primary completion: 2019-11-01
• Completion: 2020-11-01
• First posted: 2021-01-19
• Last updated: 2021-01-19