Real-world Data of Nivolumab in Pre-treated NSCLC

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04713462
• Other study ID #: H? 2B/16
• Status: Completed
• Start date: October 2015
• Est. completion date: November 2020

Study information

• Verified date: January 2021
• Source: Hellenic Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: November 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hellenic Cooperative Oncology Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of real world clinical use of Nivolumab in pre-treated NSCLC patients	Real-world clinical use	approximately 12 months
Primary	overall survival (OS)	Measured from time of initial treatment with nivolumab until date of death	approximately 12 months
Secondary	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
Secondary	Cost-effectiveness	economic evaluations based on costs of Nivolumab clinical use in Greece	approximately 12 months