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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000054053

Enrollment

150

Registered

2024-04-04

Start date

2024-02-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resectable clinical stage IIA-IIIB non-small cell lung cancer receiving neoadjuvant chemo-immunotherapy

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Cohort 1: Patients with clinical stage IIA-IIIB non-small cell lung cancer who are scheduled to receive neoadjuvant chemo-immunotherapy from the date of study approval until March 31, 2027. Cohort 2: Patients with clinical stage IIA-IIIB non-small cell lung cancer who have received or are receiving neoadjuvant chemo-immunotherapy from June 2017 until March 31, 2027.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Proportion of feasible cases for sublobar resection (segmentectomy or wedge resection) based on preoperative imaging findings	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactAtsushi Kamigaichi

Hiroshima University Department of Surgical Oncology

akamigaichi23@gmail.com082-257-5869

Outcome results