Real-world Data of Nivolumab in Pre-treated NSCLC

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

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.

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer

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 Type: Observational
• Enrollment (Actual): 346

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) as assessed by investigator	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	approximately 12 months
Cost-effectiveness	economic evaluations based on costs of Nivolumab clinical use in Greece	approximately 12 months

Collaborators and Investigators

• Sponsor: Hellenic Cooperative Oncology Group

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Actual): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: HΕ 2B/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No