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The purpose of this study is to evaluate real-world effectiveness of neoadjuvant nivolumab plus chemotherapy in France.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant nivolumab plus chemotherapy treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | As prescribed by the treating clinician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of pathological complete response on date of surgery | Up to 31 months (until loss of follow-up, death, or end of study observation period) |
| Measure | Description | Time Frame |
|---|---|---|
| Study population baseline demographics | Baseline | |
| Study population baseline clinical characteristics | Baseline | |
| Surgery rate |
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Inclusion Criteria:
Exclusion Criteria:
• Having any primary tumor other than NSCLC on or before the date of NSCLC diagnosis that required a treatment ending less than 12-months before the nivolumab plus chemotherapy neoadjuvant treatment
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The study population will include adults that have been diagnosed with resectable non-small cell lung cancer who initiated nivolumab plus chemotherapy as neoadjuvant therapy outside of clinical trial setting in France
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| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre François Baclesse | Caen | France | ||||
| Centre Léon Bérard |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| Up to 31 months (until loss of follow-up, death, or end of study observation period) |
| Time from diagnosis to start of neoadjuvant treatment | Up to 31 months (until loss of follow-up, death, or end of study observation period) |
| Average dose of nivolumab infusions | Up to 31 months (until loss of follow-up, death, or end of study observation period) |
| Frequency of nivolumab infusions | Up to 31 months (until loss of follow-up, death, or end of study observation period) |
| Duration of nivolumab treatment | Up to 31 months (until loss of follow-up, death, or end of study observation period) |
| Type of chemotherapy received in combination with nivolumab treatment as neoadjuvant treatment | Up to 31 months (until loss of follow-up, death, or end of study observation period) |
| Infusion setting (hospital or at home) | Up to 31 months (until loss of follow-up, death, or end of study observation period) |
| Survival status | at 3, 6, 9, 12, 18, and 24 months (or until loss of follow-up, death, or end of study observation period (31 months)) |
| Subsequent treatments received after nivolumab treatment | Up to 31 months (until loss of follow-up, death, or end of study observation period) |
| Disease progression/relapse status | At 3, 6, 9, 12, 18, and 24 months (or until loss of follow-up, death, or end of study observation period (31 months)) |
| Rate of major pathological response | Up to 31 months (until loss of follow-up, death, or end of study observation period) |
| Adverse events | Up to 31 months (until loss of follow-up, death, or end of study observation period) |
| Time to surgery from initial diagnosis | Up to 31 months (until loss of follow-up, death, or end of study observation period) |
| Time to surgery from the first dose of neoadjuvant therapy | Up to 31 months (until loss of follow-up, death, or end of study observation period) |
| Time to surgery from the last dose of neoadjuvant therapy | Up to 31 months (until loss of follow-up, death, or end of study observation period) |
| Surgery type | Up to 31 months (until loss of follow-up, death, or end of study observation period) |
| Duration of surgery | Up to 31 months (until loss of follow-up, death, or end of study observation period) |
| Extent of surgical resection | Up to 31 months (until loss of follow-up, death, or end of study observation period) |
| Rate of lymph node resection | Up to 31 months (until loss of follow-up, death, or end of study observation period) |
| Type of surgery complications | Up to 31 months (until loss of follow-up, death, or end of study observation period) |
| Length of hospital stay | Up to 31 months (until loss of follow-up, death, or end of study observation period) |
| Reasons for not having surgery as indicated by the multi-disciplinary tumor board | Up to 31 months (until loss of follow-up, death, or end of study observation period) |
| Lyon |
| France |
| Hospices Civils de Lyon | Lyon | France |
| Hôpital Robert Schuman | Metz | France |
| Institut du Cancer de Montpellier | Montpellier | France |
| Institute Curie | Paris | France |
| Hôpital d'Instruction des Armées Saint Anne | Toulon | France |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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