Clinical trial NCT03382496: Observational Study for Lung Cancer Patients Treated With Nivolumab
Official title: EVIDENS: Lung Cancer Patients Treated With Nivolumab: A Longitudinal, Prospective, Observational, Multicentric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-12-26
Enrollment: 1462
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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


Eligibility criteria: 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

Primary outcomes:
measure: Distribution of gender
timeFrame: At baseline
measure: Distribution of age
timeFrame: At baseline
measure: Distribution of line of therapy at nivolumab initiation
timeFrame: At baseline
measure: Distribution of ECOG PS
timeFrame: At baseline
measure: Distribution of patients working status at nivolumab initiation
timeFrame: At baseline
measure: QoL (EQ-5D) at nivolumab initiation
timeFrame: At baseline
measure: Median time from initial diagnosis to nivolumab initiation
timeFrame: At baseline
measure: Number of patients exposed to other lung cancer treatments
timeFrame: At baseline
measure: Distribution of current smokers, former smokers, and non-smokers at initial diagnosis
timeFrame: At baseline
measure: Distribution of cancer stage at initial diagnosis and at nivolumab initiation
timeFrame: At baseline
measure: Distribution of Lung cancer histology at initial diagnosis
timeFrame: At baseline
measure: Number of patients with untreated brain metastasis at nivolumab initiation
timeFrame: At baseline
measure: Number of patients with treated brain metastasis at nivolumab initiation
timeFrame: At baseline
measure: Number of patients with PD-L1 expression at nivolumab initiation
timeFrame: At baseline
measure: Number of patients with mutations at nivolumab initiation
timeFrame: At baseline
measure: Distribution of concomitant diseases at nivolumab initiation
timeFrame: At baseline
measure: Number of patients with corticosteroids treatment at nivolumab initiation
timeFrame: At baseline
measure: (OS) Overall Survival
timeFrame: Up to 3 years
Secondary outcomes:
measure: Overall Survival after initiation of nivolumab
timeFrame: Up to 2 years
measure: Distribution of nivolumab adverse drug reaction
timeFrame: At 3 years after nivolumab initiation
measure: Progression Free Survival (PFS)
timeFrame: Up to 3 years after nivolumab initiation
measure: Objective Response Rate (ORR)
timeFrame: Up to 3 years after nivolumab initiation
measure: Quality of Life (QoL)
timeFrame: Baseline to 3 years after nivolumab initiation
measure: Distribution of patient management treatment patterns
timeFrame: Baseline to 3 years
measure: Mean weight change in kilogram from baseline
timeFrame: Baseline up to 3 years
measure: Mean ECOG PS change from baseline
timeFrame: Baseline up to 3 years
measure: Distribution of patients with new metastasis
timeFrame: Up to 3 years
measure: Distribution of patients with progression of pre-existing sites
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Fontaine Les Dijon
country: France
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.