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Completed

NCT Number: NCT03382496

Observational Study for Lung Cancer Patients Treated With Nivolumab

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

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Key information

Conditions

Lung Cancer 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

Primary location

Local Institution

Fontaine-lès-Dijon, 21121, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Non-Interventional

Other

Non-Interventional

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Acronym: EVIDENS

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 26, 2017
Registry last updated
May 25, 2022

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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