Real-world Data of Nivolumab in Pre-treated NSCLC

NCT04713462 | Completed

• 1 other identifier: HΕ 2B/16
• Study Type: observational
• Target: 346
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Objective Response Rate (ORR) as assessed by investigator

  approximately 12 months

• Cost-effectiveness

  approximately 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 19, 2021
• Study Start: October 1, 2015
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2020
• Last Updated: January 19, 2021

Record last verified: 2021-01