Non-small Cell Lung Cancer (NSCLC)
Conditions
Keywords
Non-small cell lung cancer (NSCLC)
Brief summary
The purpose of this study is to evaluate real-world effectiveness of neoadjuvant nivolumab plus chemotherapy in France.
Interventions
DRUGNivolumab
As prescribed by the treating clinician
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Having a diagnosis of resectable non-small cell lung cancer (NSCLC) * Being 18 years or above at the time of their NSCLC diagnosis * Having initiated a neoadjuvant treatment with nivolumab and chemotherapy outside a clinical trial * Being indexed in the site database * Being followed at the site for at least 5 months, except for patients with a record of death
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
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | Time frame |
|---|---|
| Study population baseline clinical characteristics | Baseline |
| Surgery rate | 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)) |
| Study population baseline demographics | Baseline |
| 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) |
| Rate of major pathological response | Up to 31 months (until loss of follow-up, death, or end of study observation period) |
Countries
France
Outcome results
None listed