A Study of Participants With Advanced Non-Small Cell Lung Cancer Treated With Nivolumab in France After at Least One Prior Chemotherapy-based Treatment by Lung Initiative on Sequence Therapy
NCT ID: NCT04500535
Last Updated: 2025-11-24
Study Results
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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COMPLETED
535 participants
OBSERVATIONAL
2020-09-28
2025-04-18
Brief Summary
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* The characteristics and treatment sequence of patients treated with nivolumab
* The effectiveness of nivolumab treatment
* The safety profile of nivolumab
* Treatment patterns (e.g. duration of treatment, subsequent treatments) of nivolumab
* The patient-reported outcomes (PRO) in patients treated with nivolumab, at baseline and during follow up using the EuroQoL-5D-3L
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1
Immuno-oncology (IO)-naïve patients
No interventions assigned to this group
Cohort 2
IO-experienced patients for whom last IO discontinuation was not primarily related to IO-toxicity
No interventions assigned to this group
Cohort 3
IO-experienced patients for whom last IO discontinuation was primarily due to IO-toxicity
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Whose physician has already decided to initiate a treatment with nivolumab for the treatment of advanced NSCLC according to the European label
* Previously treated with at least one prior chemotherapy- containing regimen
Exclusion Criteria
* Participants with a diagnosis of another primary cancer within the past five years
* Participants receiving IO within 12 weeks prior to nivolumab first infusion in the context of the present study
18 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0001
Paris, , France
Countries
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References
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Godbert B, Gobbini E, Decroisette C, Lena H, Khalife Y, Brellier F, Fleuriet A, Zysman M, Egenod T, Moro Sibilot D, Girard N. Real-World Use and Immunotherapy Rechallenge Outcomes with Nivolumab in Advanced Non-small Cell Lung Cancer in France: Interim Results of the LIST Study. Oncol Ther. 2025 Sep 14. doi: 10.1007/s40487-025-00381-z. Online ahead of print.
Related Links
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BMS Clinical Trial Information
FDA Safety Alerts and Recalls
Other Identifiers
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CA209-7HX
Identifier Type: -
Identifier Source: org_study_id
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