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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

535 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-28

Study Completion Date

2025-04-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this trial is to describe the following, for each cohort, in real world conditions in France:

* 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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pathologically confirmed diagnosis of advanced NSCLC
* 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 taking part in an interventional study for lung cancer treatment for which nivolumab is one of the investigational drugs
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Local Institution - 0001

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40946253 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CA209-7HX

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

TAilored Post-Surgical Therapy in Early Stage NSCLC
NCT00775385 COMPLETED PHASE2/PHASE3