This study uses existing medical records to better understand how immunotherapy is used in people in Europe and Canada with non-small cell lung cancer (NSCLC) who undergo surgery. It looks at participant characteristics, treatments received before and after surgery, and outcomes such as survival.
Study Type
OBSERVATIONAL
Enrollment
300
As per product label
As per product label
As per product label
IQVIA
London, United Kingdom
Number of participants with pathological complete response after neoadjuvant immunotherapy and surgical resection.
Pathological complete response (pCR) is defined as 0% residual viable tumor cells in the primary tumor and all sampled regional lymph nodes following neoadjuvant immunotherapy and surgical resection.
Time frame: Up to 14 months
Number of participants with major pathological response after neoadjuvant immunotherapy and surgical resection.
Major pathological response (MPR) is defined as ≤10% residual viable tumor cells in the primary tumor and all sampled regional lymph nodes following neoadjuvant immunotherapy and surgical resection.
Time frame: Up to 14 months
Number of participants with post-operative complications following surgical resection
Post-operative complications include infection, pneumonia, respiratory failure requiring assisted ventilation or intubation, immune-related pneumonitis, myocardial infarction, atrial fibrillation, cardiac failure, unplanned intensive care unit admission, stroke, acute renal failure, bronchopleural fistula, empyema, re-operation, prolonged hospitalization, prolonged air leak greater than 5 days, in-hospital death, 30-day death, and 90-day death.
Time frame: Up to 90 days
Number of participants by surgical resection margin status
Surgical resection margin status following surgery will be categorized as R0 (no residual tumor), R1 (microscopic residual tumor), or R2 (macroscopic residual tumor).
Time frame: Up to 14 months
Number of participants by surgical resection type
Surgical resection type will be categorized as lobectomy, bilobectomy, segmentectomy, wedge resection, pneumonectomy, or sleeve resection.
Time frame: Day 1
Number of participants by surgical approach
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Surgical approach will be categorized as open thoracotomy, video-assisted thoracoscopic surgery (VATS), or robotic-assisted surgery.
Time frame: Day 1
Number of participants with all-cause mortality within 90 days after surgery
All-cause mortality occurring during hospitalization or within 90 days after surgical resection will be summarized.
Time frame: Up to 90 days
Overall survival from surgical resection
Overall survival (OS) is defined as the time from surgical resection to death from any cause.
Time frame: Up to 46 months
Event-free survival from surgical resection
Event-free survival (EFS) is defined as the time from surgical resection to the first occurrence of disease recurrence or progression after surgery, or death from any cause.
Time frame: Up to 46 months
Number of participants initiating adjuvant immunotherapy after surgery
Adjuvant immunotherapy includes pembrolizumab, durvalumab, or nivolumab.
Time frame: Up to 14 months
Time (days) from surgery to initiation of adjuvant immunotherapy
Time frame: Up to 14 months
Number of participants receiving post-surgical systemic and local therapies
Post-surgical therapies received during follow-up will be summarized and include adjuvant immunotherapy, adjuvant chemotherapy, radiotherapy, targeted therapy, and advanced or metastatic treatments.
Time frame: Up to 46 months
Length of hospital stay (days) following surgical resection
Time frame: Up to 90 days
Number of participants with immune-mediated adverse events (AEs) during neoadjuvant immunotherapy
Time frame: Up to 22 months