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The purpose of this trial is to describe the following, for each cohort, in real world conditions in France:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to treatment failure (TTF) | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Up to 3 years | |
| Progression-free survival (PFS) | Up to 3 years | |
| Time to next therapy (TTNT) |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Paris | 75248 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42071088 | Derived | 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. | |
| 40946253 |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| Up to 3 years |
| Best overall response rate (BORR) | Up to 3 years |
| Distribution of participant demographics characteristics: Age | Index date (treatment initiation date for each individual patient |
| Distribution of participant demographics characteristics: Sex | Index date (treatment initiation date for each individual patient) |
| Distribution of clinical characteristics: Smoking status | Index date (treatment initiation date for each individual patient) |
| Distribution of clinical characteristics: ECOG at initial diagnosis and at nivolumab initiation | Index date (treatment initiation date for each individual patient) |
| Distribution of clinical characteristics: Histology | Index date (treatment initiation date for each individual patient) |
| Distribution of clinical characteristics: TNM classification | TNM=Tumor Nodes Metastases | Index date (treatment initiation date for each individual patient) |
| Distribution of clinical characteristics: Location of metastases | Index date (treatment initiation date for each individual patient) |
| Distribution of clinical characteristics: EGFR mutation | EGRF=Epidural Growth Factor Receptor | Index date (treatment initiation date for each individual patient) |
| Distribution of clinical characteristics: ALK translocation | ALK= Anaplastic Lymphoma Kinase | Index date (treatment initiation date for each individual patient) |
| Distribution of clinical characteristics: HER2 mutation | HER2=Human Epidermal Growth Factor Receptor 2 | Index date (treatment initiation date for each individual patient) |
| Distribution of clinical characteristics: BRAF mutation | Index date (treatment initiation date for each individual patient) |
| Distribution of clinical characteristics: KRAS mutation | Index date (treatment initiation date for each individual patient) |
| Distribution of clinical characteristics: ROS1 mutation | Index date (treatment initiation date for each individual patient) |
| Distribution of clinical characteristics: MET mutation | Index date (treatment initiation date for each individual patient) |
| Distribution of clinical characteristics: PD-L1 expression | PD-L1=Programmed Death Ligand 1 | 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 | Index date (treatment initiation date for each individual patient) |
| Incidence of Adverse Drug Reactions | 36 months after nivolumab treatment initiation |
| Incidence of Seriousness criteria | 36 months after nivolumab treatment initiation |
| Incidence of Intensity/ Grade | 36 months after nivolumab treatment initiation |
| Incidence of AE duration | Follow-up period (Week 4 to Week 156) |
| Incidence of Action taken regarding the BMS treatment | Follow-up period (Week 4 to Week 156) |
| Incidence of Incidence rate | Follow-up period (Week 4 to Week 156) |
| 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 Dec;13(4):1071-1086. doi: 10.1007/s40487-025-00381-z. Epub 2025 Sep 14. |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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