Observational Study for Lung Cancer Patients Treated With Nivolumab

Lung Cancer Clinical Trial

— EVIDENS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03382496
• Other study ID #: CA209-417
• Status: Completed
• Start date: October 1, 2016
• Est. completion date: December 23, 2020

Study information

• Verified date: May 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1462
• Est. completion date: December 23, 2020
• Est. primary completion date: December 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations

Country	Name	City	State
France	Local Institution	Fontaine Les Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution of gender		At baseline
Primary	Distribution of age		At baseline
Primary	Distribution of line of therapy at nivolumab initiation		At baseline
Primary	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
Primary	Distribution of patients working status at nivolumab initiation		At baseline
Primary	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
Primary	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
Primary	Number of patients exposed to other lung cancer treatments		At baseline
Primary	Distribution of current smokers, former smokers, and non-smokers at initial diagnosis		At baseline
Primary	Distribution of cancer stage at initial diagnosis and at nivolumab initiation		At baseline
Primary	Distribution of Lung cancer histology at initial diagnosis		At baseline
Primary	Number of patients with untreated brain metastasis at nivolumab initiation		At baseline
Primary	Number of patients with treated brain metastasis at nivolumab initiation		At baseline
Primary	Number of patients with PD-L1 expression at nivolumab initiation	PD-LI (Programmed death-ligand 1)	At baseline
Primary	Number of patients with mutations at nivolumab initiation		At baseline
Primary	Distribution of concomitant diseases at nivolumab initiation		At baseline
Primary	Number of patients with corticosteroids treatment at nivolumab initiation		At baseline
Primary	(OS) Overall Survival	Time from index date (treatment with nivolumab) until date of death due to any cause	Up to 3 years
Secondary	Overall Survival after initiation of nivolumab		Up to 2 years
Secondary	Distribution of nivolumab adverse drug reaction		At 3 years after nivolumab initiation
Secondary	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
Secondary	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
Secondary	Quality of Life (QoL)		Baseline to 3 years after nivolumab initiation
Secondary	Distribution of patient management treatment patterns		Baseline to 3 years
Secondary	Mean weight change in kilogram from baseline		Baseline up to 3 years
Secondary	Mean ECOG PS change from baseline		Baseline up to 3 years
Secondary	Distribution of patients with new metastasis		Up to 3 years
Secondary	Distribution of patients with progression of pre-existing sites		Up to 3 years

External Links

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