Lung CancerLISTNCT04500535
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
An observational study of Lung Cancer, run by Bristol-Myers Squibb at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- How many people
- 535 participants
- Where
- 1 siteFrance
- Study dates
- 28 Sep 2020to 18 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The target population will be constituted using multistage sampling, in which physicians (pulmonologists and/or oncologists) from eligible hospitals are to identify and recruit the participants. Eligible hospitals will be selected among PMSI sites (national hospital discharge database) and only hospitals with a minimum of 40 patients treated for lung cancer and with chemotherapy in 2018 will be considered to ensure sufficient enrollment.
Who may be able to join
- 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
Who cannot join
- 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
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Center, Longitudinal, Prospective, Observational, Multi-Cohort Study of Patients With Advanced Non-Small Cell Lung Cancer Treated With Nivolumab in France After at Least One Prior Chemotherapy-based Treatment (LIST, Lung Initiative on Sequence Therapy)
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
- Conditions
- Lung Cancer
- Keywords
- Non Small Cell Lung Cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Immuno-oncology (IO)-naïve patients | |
| Cohort 2 | IO-experienced patients for whom last IO discontinuation was not primarily related to IO-toxicity | |
| Cohort 3 | IO-experienced patients for whom last IO discontinuation was primarily due to IO-toxicity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment failure (TTF)
Measured: Up to 3 years
Secondary outcomes (26)
Overall survival (OS)
Measured: Up to 3 years
Progression-free survival (PFS)
Measured: Up to 3 years
Time to next therapy (TTNT)
Measured: Up to 3 years
Best overall response rate (BORR)
Measured: Up to 3 years
Distribution of participant demographics characteristics: Age
Measured: Index date (treatment initiation date for each individual patient
Distribution of participant demographics characteristics: Sex
Measured: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: Smoking status
Measured: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: ECOG at initial diagnosis and at nivolumab initiation
Measured: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: Histology
Measured: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: TNM classification
TNM=Tumor Nodes Metastases
Measured: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: Location of metastases
Measured: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: EGFR mutation
EGRF=Epidural Growth Factor Receptor
Measured: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: ALK translocation
ALK= Anaplastic Lymphoma Kinase
Measured: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: HER2 mutation
HER2=Human Epidermal Growth Factor Receptor 2
Measured: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: BRAF mutation
Measured: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: KRAS mutation
Measured: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: ROS1 mutation
Measured: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: MET mutation
Measured: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: PD-L1 expression
PD-L1=Programmed Death Ligand 1
Measured: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: PD-L1 expression on tumor or stromal cells
PD-L1=Programmed Death Ligand 1
Measured: Index date (treatment initiation date for each individual patient)
Incidence of Adverse Drug Reactions
Measured: 36 months after nivolumab treatment initiation
Incidence of Seriousness criteria
Measured: 36 months after nivolumab treatment initiation
Incidence of Intensity/ Grade
Measured: 36 months after nivolumab treatment initiation
Incidence of AE duration
Measured: Follow-up period (Week 4 to Week 156)
Incidence of Action taken regarding the BMS treatment
Measured: Follow-up period (Week 4 to Week 156)
Incidence of Incidence rate
Measured: Follow-up period (Week 4 to Week 156)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start28 Sep 2020
- Primary completion18 Apr 2025
- Study completion18 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 535 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500535
- Sponsor's protocol ID
- CA209-7HX
- Acronym
- LIST
- Status last verified
- Nov 2025
- First submitted
- 3 Aug 2020
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
Publications
Godbert B, Gobbini E, Khalife Y, Decroisette C, Brellier F, Lena H, Fleuriet A, Zysman M, Egenod T, Girard N. Treatment Sequencing and Immunotherapy Rechallenge in Advanced Non-Small-Cell Lung Cancer: Final 24-Month Real-World Results from the French LIST Study. Oncol Ther. 2026 Jun;14(2):721-734. doi: 10.1007/s40487-026-00437-8. Epub 2026 May 3.
PubMed 42071088Godbert 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 Dec;13(4):1071-1086. doi: 10.1007/s40487-025-00381-z. Epub 2025 Sep 14.
PubMed 40946253
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Longitudinal, Prospective, Observational, Multi-Cohort Study of Patients With Advanced Non-Small Cell Lung Cancer Treated With Nivolumab in France After at Least One Prior Chemotherapy-based Treatment (LIST, Lung Initiative on Sequence Therapy)
- ClinicalTrials.gov ID
- NCT04500535
- Acronym / sponsor ID
- LIST / CA209-7HX
- Conditions
- Lung Cancer
- Keywords
- Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Immuno-oncology (IO)-naïve patients |
| Cohort 2 | – | –IO-experienced patients for whom last IO discontinuation was not primarily related to IO-toxicity |
| Cohort 3 | – | –IO-experienced patients for whom last IO discontinuation was primarily due to IO-toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The target population will be constituted using multistage sampling, in which physicians (pulmonologists and/or oncologists) from eligible hospitals are to identify and recruit the participants. Eligible hospitals will be selected among PMSI sites (national hospital discharge database) and only hospitals with a minimum of 40 patients treated for lung cancer and with chemotherapy in 2018 will be considered to ensure sufficient enrollment.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
- Other protocol-defined inclusion/exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to treatment failure (TTF)
Time frame: Up to 3 years
26 secondary outcomes
Overall survival (OS)
Time frame: Up to 3 years
Progression-free survival (PFS)
Time frame: Up to 3 years
Time to next therapy (TTNT)
Time frame: Up to 3 years
Best overall response rate (BORR)
Time frame: Up to 3 years
Distribution of participant demographics characteristics: Age
Time frame: Index date (treatment initiation date for each individual patient
Distribution of participant demographics characteristics: Sex
Time frame: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: Smoking status
Time frame: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: ECOG at initial diagnosis and at nivolumab initiation
Time frame: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: Histology
Time frame: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: TNM classification
Time frame: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: Location of metastases
Time frame: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: EGFR mutation
Time frame: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: ALK translocation
Time frame: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: HER2 mutation
Time frame: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: BRAF mutation
Time frame: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: KRAS mutation
Time frame: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: ROS1 mutation
Time frame: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: MET mutation
Time frame: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: PD-L1 expression
Time frame: Index date (treatment initiation date for each individual patient)
Distribution of clinical characteristics: PD-L1 expression on tumor or stromal cells
Time frame: Index date (treatment initiation date for each individual patient)
Incidence of Adverse Drug Reactions
Time frame: 36 months after nivolumab treatment initiation
Incidence of Seriousness criteria
Time frame: 36 months after nivolumab treatment initiation
Incidence of Intensity/ Grade
Time frame: 36 months after nivolumab treatment initiation
Incidence of AE duration
Time frame: Follow-up period (Week 4 to Week 156)
Incidence of Action taken regarding the BMS treatment
Time frame: Follow-up period (Week 4 to Week 156)
Incidence of Incidence rate
Time frame: Follow-up period (Week 4 to Week 156)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Derived from this study: PubMed 42071088Godbert B, Gobbini E, Khalife Y, Decroisette C, Brellier F, Lena H, Fleuriet A, Zysman M, Egenod T, Girard N. Treatment Sequencing and Immunotherapy Rechallenge in Advanced Non-Small-Cell Lung Cancer: Final 24-Month Real-World Results from the French LIST Study. Oncol Ther. 2026 Jun;14(2):721-734. doi: 10.1007/s40487-026-00437-8. Epub 2026 May 3.
- Derived from this study: PubMed 40946253Godbert 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 Dec;13(4):1071-1086. doi: 10.1007/s40487-025-00381-z. Epub 2025 Sep 14.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Bristol-Myers Squibb at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to treatment failure (TTF) (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04500535, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.