An observational study in Non-small Cell Lung Cancer (NSCLC), sponsored by Bristol-Myers Squibb. Completed at 7 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by Bristol-Myers Squibb · Observational
The purpose of this study is to evaluate real-world effectiveness of neoadjuvant nivolumab plus chemotherapy in France.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 101 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Drug: Nivolumab
As prescribed by the treating clinician
Rate of pathological complete response on date of surgery
Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Study population baseline demographics
Time frame: Baseline
Study population baseline clinical characteristics
Time frame: Baseline
Surgery rate
Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Time from diagnosis to start of neoadjuvant treatment
Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Average dose of nivolumab infusions
Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Frequency of nivolumab infusions
Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Duration of nivolumab treatment
Time frame: 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
Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Infusion setting (hospital or at home)
Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Survival status
Time frame: 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
Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Disease progression/relapse status
Time frame: 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
Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Adverse events
Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Time to surgery from initial diagnosis
Time frame: 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
Time frame: 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
Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Surgery type
Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Duration of surgery
Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Extent of surgical resection
Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Rate of lymph node resection
Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Type of surgery complications
Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Length of hospital stay
Time frame: 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
Time frame: Up to 31 months (until loss of follow-up, death, or end of study observation period)
Plan to share: No
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Bristol-Myers Squibb