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OpenTrials
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NCT Number: NCT04713462

Real-world Data of Nivolumab in Pre-treated NSCLC

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.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Description of real world clinical use of Nivolumab in pre-treated NSCLC patients

    Time frame: approximately 12 months

    Real-world clinical use

  2. overall survival (OS)

    Time frame: approximately 12 months

    Measured from time of initial treatment with nivolumab until date of death

Secondary outcomes

  1. Objective Response Rate (ORR) as assessed by investigator

    Time frame: 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

  2. Cost-effectiveness

    Time frame: approximately 12 months

    economic evaluations based on costs of Nivolumab clinical use in Greece

Sponsors and collaborators

Lead sponsor

Hellenic Cooperative Oncology Group

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Jan 19, 2021
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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