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

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ClinicalTrials.gov Identifier: NCT03382496
Recruitment Status : Completed
First Posted : December 26, 2017
Last Update Posted : May 25, 2022
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Lung Cancer Other: Non-Interventional

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Study Type : Observational
Actual Enrollment : 1462 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: EVIDENS: Lung Cancer Patients Treated With Nivolumab: A Longitudinal, Prospective, Observational, Multicentric Study
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : December 23, 2020
Actual Study Completion Date : December 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Nivolumab

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

Primary Outcome Measures :
  1. Distribution of gender [ Time Frame: At baseline ]
  2. Distribution of age [ Time Frame: At baseline ]
  3. Distribution of line of therapy at nivolumab initiation [ Time Frame: At baseline ]
  4. Distribution of ECOG PS [ Time Frame: 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

  5. Distribution of patients working status at nivolumab initiation [ Time Frame: At baseline ]
  6. QoL (EQ-5D) at nivolumab initiation [ Time Frame: 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)

  7. Median time from initial diagnosis to nivolumab initiation [ Time Frame: 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

  8. Number of patients exposed to other lung cancer treatments [ Time Frame: At baseline ]
  9. Distribution of current smokers, former smokers, and non-smokers at initial diagnosis [ Time Frame: At baseline ]
  10. Distribution of cancer stage at initial diagnosis and at nivolumab initiation [ Time Frame: At baseline ]
  11. Distribution of Lung cancer histology at initial diagnosis [ Time Frame: At baseline ]
  12. Number of patients with untreated brain metastasis at nivolumab initiation [ Time Frame: At baseline ]
  13. Number of patients with treated brain metastasis at nivolumab initiation [ Time Frame: At baseline ]
  14. Number of patients with PD-L1 expression at nivolumab initiation [ Time Frame: At baseline ]
    PD-LI (Programmed death-ligand 1)

  15. Number of patients with mutations at nivolumab initiation [ Time Frame: At baseline ]
  16. Distribution of concomitant diseases at nivolumab initiation [ Time Frame: At baseline ]
  17. Number of patients with corticosteroids treatment at nivolumab initiation [ Time Frame: At baseline ]
  18. (OS) Overall Survival [ Time Frame: Up to 3 years ]
    Time from index date (treatment with nivolumab) until date of death due to any cause

Secondary Outcome Measures :
  1. Overall Survival after initiation of nivolumab [ Time Frame: Up to 2 years ]
  2. Distribution of nivolumab adverse drug reaction [ Time Frame: At 3 years after nivolumab initiation ]
  3. Progression Free Survival (PFS) [ Time Frame: 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

  4. Objective Response Rate (ORR) [ Time Frame: 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

  5. Quality of Life (QoL) [ Time Frame: Baseline to 3 years after nivolumab initiation ]
  6. Distribution of patient management treatment patterns [ Time Frame: Baseline to 3 years ]
  7. Mean weight change in kilogram from baseline [ Time Frame: Baseline up to 3 years ]
  8. Mean ECOG PS change from baseline [ Time Frame: Baseline up to 3 years ]
  9. Distribution of patients with new metastasis [ Time Frame: Up to 3 years ]
  10. Distribution of patients with progression of pre-existing sites [ Time Frame: Up to 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382496

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Local Institution
Fontaine Les Dijon, France, 21121
Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03382496    
Other Study ID Numbers: CA209-417
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: May 25, 2022
Last Verified: May 2022
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases