Observational Study for Lung Cancer Patients Treated With Nivolumab

NCT ID: NCT03382496

Last Updated: 2022-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1462 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-01

Study Completion Date

2020-12-23

Brief Summary

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

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lung Cancer patients in France

Lung Cancer patients treated by nivolumab in real life condition in France from October 2016 to October 2017

Non-Interventional

Intervention Type OTHER

Non-Interventional

Interventions

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Non-Interventional

Non-Interventional

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Fontaine-lès-Dijon, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 33457089 (View on PubMed)

Related Links

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Other Identifiers

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CA209-417

Identifier Type: -

Identifier Source: org_study_id

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