Observational Study for Lung Cancer Patients Treated With Nivolumab

NCT03382496 | Completed

• 1 other identifier: CA209-417
• Study Type: observational
• Target: 1,462
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (18)

• 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 Outcomes (10)

• 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)

  Up to 3 years after nivolumab initiation

• Objective Response Rate (ORR)

  Up to 3 years after nivolumab initiation

• Quality of Life (QoL)

  Baseline to 3 years after nivolumab initiation

Study Arms (1)

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

Interventions

Non-Interventional OTHER

Non-Interventional

Lung Cancer patients in France

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Fontaine-lès-Dijon, 21121, France

Location

Related Publications (1)

• 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.

  PMID: 33457089 DERIVED

Related Links

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

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: December 26, 2017
• Study Start: October 1, 2016
• Primary Completion: December 23, 2020
• Study Completion: December 23, 2020
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

FR (1)