Observational Study for Lung Cancer Patients Treated With Nivolumab

Completed

• Conditions: Lung Cancer
• Interventions: Other: Non-Interventional

• Registration Number: NCT03382496
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2017-12-19
• Study First Posted: 2017-12-26
• Primary Completion: 2020-12-23
• Study Completion: 2020-12-23
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1462

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung Cancer patients in France	Non-Interventional	Lung Cancer patients treated by nivolumab in real life condition in France from October 2016 to October 2017

Primary Outcome Measures

Name	Time	Method
Distribution of patients working status at nivolumab initiation	At baseline
Number of patients with treated brain metastasis at nivolumab initiation	At baseline
Distribution of cancer stage at initial diagnosis and at nivolumab initiation	At baseline
(OS) Overall Survival	Up to 3 years	Time from index date (treatment with nivolumab) until date of death due to any cause
Distribution of ECOG PS	At baseline	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
Distribution of Lung cancer histology at initial diagnosis	At baseline
Number of patients with PD-L1 expression at nivolumab initiation	At baseline	PD-LI (Programmed death-ligand 1)
Distribution of gender	At baseline
Distribution of line of therapy at nivolumab initiation	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
Number of patients with untreated brain metastasis at nivolumab initiation	At baseline
Number of patients with mutations at nivolumab initiation	At baseline
Median time from initial diagnosis to nivolumab initiation	At baseline	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
Distribution of concomitant diseases at nivolumab initiation	At baseline
Number of patients with corticosteroids treatment at nivolumab initiation	At baseline
Distribution of age	At baseline
QoL (EQ-5D) at nivolumab initiation	At baseline	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)

Secondary Outcome Measures

Name	Time	Method
Distribution of patient management treatment patterns	Baseline to 3 years
Distribution of nivolumab adverse drug reaction	At 3 years after nivolumab initiation
Distribution of patients with new metastasis	Up to 3 years
Overall Survival after initiation of nivolumab	Up to 2 years
Mean weight change in kilogram from baseline	Baseline up to 3 years
Distribution of patients with progression of pre-existing sites	Up to 3 years
Progression Free Survival (PFS)	Up to 3 years after nivolumab initiation	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
Quality of Life (QoL)	Baseline to 3 years after nivolumab initiation
Objective Response Rate (ORR)	Up to 3 years after nivolumab initiation	ORR is measured by the sum of partial responses plus complete responses as assessed by (RECIST 1.1) Response Evaluation Criteria In Solid Tumors
Mean ECOG PS change from baseline	Baseline up to 3 years

Trial Locations

Locations (1)

Local Institution; 🇫🇷 Fontaine Les Dijon, France