Real-world Data of Nivolumab in Pre-treated NSCLC

Completed

• Conditions: Non Small Cell Lung Cancer

• Registration Number: NCT04713462
• Lead Sponsor: Hellenic Cooperative Oncology Group

Brief 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.

Study Timeline

• Study Start: 2015-10
• Primary Completion: 2019-11
• Study Completion: 2020-11
• Status Verified: 2021-01
• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-15
• Last Update Submitted: 2021-01-15
• Study First Posted: 2021-01-19
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 346

Inclusion Criteria

• Patients with a diagnosis of advanced Squamous or Non-Squamous NSCLC (histologically or cytologically confirmed), who had relapsed after 1 prior platinum-based systemic treatment and who received treatment with nivolumab
• nivolumab treatment received in participating HeCOG centres between October 2015 and November 2019
• Alive patients must have signed and dated the study approved written informed consent form in accordance with regulatory and institutional guidelines, obtained before any protocol-related procedures that are not part of normal patient care.

Exclusion Criteria

• Alive patients who do not want to sign and date the study approved written informed consent form
• Patients that participated in any other clinical trial prior or after nivolumab treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Description of real world clinical use of Nivolumab in pre-treated NSCLC patients	approximately 12 months	Real-world clinical use
overall survival (OS)	approximately 12 months	Measured from time of initial treatment with nivolumab until date of death

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness	approximately 12 months	economic evaluations based on costs of Nivolumab clinical use in Greece
Objective Response Rate (ORR) as assessed by investigator	approximately 12 months	the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the total number of participants who received treatment