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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Diagnosed with non-small-cell lung cancer (NSCLC) stage IIA to IIIB
* Participants aged ≥18 years at time of NSCLC diagnosis
* Initiated and received neoadjuvant nivolumab or neoadjuvant phase of perioperative immunotherapy during the patient inclusion period
* Documented record of curative surgical resection following receipt of neoadjuvant nivolumab or neoadjuvant phase of perioperative immunotherapy
* NSCLC is assessed as resectable by a clinician, surgeon, or multidisciplinary team.
Exclusion Criteria:
• Diagnosis of another primary malignancy (excluding non-melanoma skin cancer) within 5 years prior to NSCLC diagnosis or at any time after diagnosis
Primary outcome measure(s)
Number of participants with pathological complete response after neoadjuvant immunotherapy and surgical resection. — Up to 14 months 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.
Number of participants with major pathological response after neoadjuvant immunotherapy and surgical resection. — Up to 14 months 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.
Number of participants with post-operative complications following surgical resection — Up to 90 days 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.
Number of participants by surgical resection margin status — Up to 14 months Surgical resection margin status following surgery will be categorized as R0 (no residual tumor), R1 (microscopic residual tumor), or R2 (macroscopic residual tumor).
Number of participants by surgical resection type — Day 1 Surgical resection type will be categorized as lobectomy, bilobectomy, segmentectomy, wedge resection, pneumonectomy, or sleeve resection.
Number of participants by surgical approach — Day 1 Surgical approach will be categorized as open thoracotomy, video-assisted thoracoscopic surgery (VATS), or robotic-assisted surgery.
Number of participants with all-cause mortality within 90 days after surgery — Up to 90 days All-cause mortality occurring during hospitalization or within 90 days after surgical resection will be summarized.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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