Observational Study for Lung Cancer Patients Treated With Nivolumab (EVIDENS)

EVIDENS: Lung Cancer Patients Treated With Nivolumab: A Longitudinal, Prospective, Observational, Multicentric Study

This study will describe the characteristics of patients initiating nivolumab treatment for lung cancer and their outcomes over 3 years in France

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Non-Interventional

• Study Type: Observational
• Enrollment (Actual): 1462

Contacts and Locations

Study Locations

• France
  • Fontaine Les Dijon, France, 21121
    • Local Institution

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

This study aims to collect data for patients diagnosed with a lung cancer and initiating nivolumab in France

Description

Inclusion Criteria:

• Male or female: 18 age at the time of nivolumab initiation
• Pathologically confirmed diagnosis of lung cancer
• Patient initiating nivolumab :therapeutic decision to initiate nivolumab must be taken by the physician prior to enrolling a patient in the study

Exclusion Criteria:

-Patient taking part in an interventional study for lung cancer treatment for which nivolumab is 1 of the investigational drugs

Other protocol defined inclusion or exclusion criteria could apply

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lung Cancer patients in France; Lung Cancer patients treated by nivolumab in real life condition in France from October 2016 to October 2017	Other: Non-Interventional; Non-Interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of gender		At baseline
Distribution of age		At baseline
Distribution of line of therapy at nivolumab initiation		At baseline
Distribution of ECOG PS	Eastern Cooperative Oncology Group Performance Status (ECOG PS) A scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis	At baseline
Distribution of patients working status at nivolumab initiation		At baseline
QoL (EQ-5D) at nivolumab initiation	Quality of Life (QoL) as assessed by European Quality of Life-5 Dimensions (EQ-5D) EQ-5D: the descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with 3 levels (eg, no problems, moderate problems, extreme problems)	At baseline
Median time from initial diagnosis to nivolumab initiation	Median time from initial diagnosis to nivolumab initiation (derived from date of initial diagnosis and date of first dose of nivolumab, assumed to be the date of D0 visit). Any lung cancer declaring more than 5 years after another cancer is defined as an initial diagnosis of lung cancer	At baseline
Number of patients exposed to other lung cancer treatments		At baseline
Distribution of current smokers, former smokers, and non-smokers at initial diagnosis		At baseline
Distribution of cancer stage at initial diagnosis and at nivolumab initiation		At baseline
Distribution of Lung cancer histology at initial diagnosis		At baseline
Number of patients with untreated brain metastasis at nivolumab initiation		At baseline
Number of patients with treated brain metastasis at nivolumab initiation		At baseline
Number of patients with PD-L1 expression at nivolumab initiation	PD-LI (Programmed death-ligand 1)	At baseline
Number of patients with mutations at nivolumab initiation		At baseline
Distribution of concomitant diseases at nivolumab initiation		At baseline
Number of patients with corticosteroids treatment at nivolumab initiation		At baseline
(OS) Overall Survival	Time from index date (treatment with nivolumab) until date of death due to any cause	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival after initiation of nivolumab		Up to 2 years
Distribution of nivolumab adverse drug reaction		At 3 years after nivolumab initiation
Progression Free Survival (PFS)	PFS measured by time since index date (initial treatment with nivolumab) to either the first disease progression date or last known tumor assessment date, or death due to any cause, whichever occurs first as assessed by RECIST 1.1	Up to 3 years after nivolumab initiation
Objective Response Rate (ORR)	ORR is measured by the sum of partial responses plus complete responses as assessed by (RECIST 1.1) Response Evaluation Criteria In Solid Tumors	Up to 3 years after nivolumab initiation
Quality of Life (QoL)		Baseline to 3 years after nivolumab initiation
Distribution of patient management treatment patterns		Baseline to 3 years
Mean weight change in kilogram from baseline		Baseline up to 3 years
Mean ECOG PS change from baseline		Baseline up to 3 years
Distribution of patients with new metastasis		Up to 3 years
Distribution of patients with progression of pre-existing sites		Up to 3 years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

General Publications

• Barlesi F, Dixmier A, Debieuvre D, Raspaud C, Auliac JB, Benoit N, Bombaron P, Moro-Sibilot D, Audigier-Valette C, Asselain B, Egenod T, Rabeau A, Fayette J, Sanchez ML, Labourey JL, Westeel V, Lamoureux P, Cotte FE, Allan V, Daumont M, Dumanoir J, Reynaud D, Calvet CY, Ozan N, Perol M. Effectiveness and safety of nivolumab in the treatment of lung cancer patients in France: preliminary results from the real-world EVIDENS study. Oncoimmunology. 2020 Apr 12;9(1):1744898. doi: 10.1080/2162402X.2020.1744898.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): December 23, 2020
• Study Completion (Actual): December 23, 2020

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

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; Lung Neoplasms
• Other Study ID Numbers: CA209-417