A real-world observational study evaluating efficacy and safety of neoadjuvant chemo-immunotherapy in patients with resectable non-small cell lung cancer (Neo FACT)

UMIN ID: UMIN000054053

Registered date:04/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Resectable clinical stage IIA-IIIB non-small cell lung cancer receiving neoadjuvant chemo-immunotherapy
• Date of first enrollment: 2024/02/16
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Proportion of feasible cases for sublobar resection (segmentectomy or wedge resection) based on preoperative imaging findings
• Secondary Outcome: Proportion of feasible cases for sublobar resection (segmentectomy or wedge resection) based on intraoperative findings Concordance of feasibility of sublobar resection between preoperative imaging and intraoperative findings Concordance of treatment efficacy between preoperative and pathological findings Concordance of treatment efficacy between primary lesion and involved lymph nodes Clinicopathological characteristics of feasible cases for sublobar resection Completion rate of preoperative treatment Complete resection rate Pathological response rate Rate of adverse events Overall survival Event-free survival

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: For both Cohorts 1 and 2: 1. Patients deemed inappropriate by the principal investigator. 2. Patients under the age of 18 at the time of surgery.

Related Information

• Primary Sponsor: Hiroshima University
• Source(s) of Monetary Support: None