Non-Small Cell Lung Cancer
Conditions
Keywords
Non-Small Cell Lung Cancer, NSCLC, neoadjuvant immunotherapy, perioperative immunotherapy, nivolumab;
Brief summary
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.
Interventions
BIOLOGICALnivolumab
As per product label
BIOLOGICALpembrolizumab
As per product label
BIOLOGICALdurvalumab
As per product label
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival from surgical resection | Up to 46 months | Overall survival (OS) is defined as the time from surgical resection to death from any cause. |
| Event-free survival from surgical resection | Up to 46 months | 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. |
| Number of participants initiating adjuvant immunotherapy after surgery | Up to 14 months | Adjuvant immunotherapy includes pembrolizumab, durvalumab, or nivolumab. |
| Time (days) from surgery to initiation of adjuvant immunotherapy | Up to 14 months | — |
| Number of participants receiving post-surgical systemic and local therapies | Up to 46 months | Post-surgical therapies received during follow-up will be summarized and include adjuvant immunotherapy, adjuvant chemotherapy, radiotherapy, targeted therapy, and advanced or metastatic treatments. |
| Length of hospital stay (days) following surgical resection | Up to 90 days | — |
| Number of participants with immune-mediated adverse events (AEs) during neoadjuvant immunotherapy | Up to 22 months | — |
Countries
United Kingdom
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed