NCT07250360

Adjuvant Chemotherapy for High-Risk Pathologic Stage I Non-Squamous NSCLC

Adjuvant Chemotherapy Confers Survival Benefit Only in High-Risk Pathologic Stage I Non-Squamous NSCLC: A Multicenter Prospective Cohort Study and Machine-Learning-Based Decision Tool

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,072 (actual)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Brief Summary The goal of this clinical trial is to evaluate the effect of postoperative adjuvant chemotherapy (ACT) in patients with stage I non-squamous non-small cell lung cancer (NSCLC) after curative resection. The main questions it aims to answer are: Does ACT improve recurrence-free survival (RFS) compared with observation alone? Does ACT provide disease-free survival (DFS) benefit in this patient population? Researchers will compare the adjuvant chemotherapy group with the observation group to see if chemotherapy reduces the risk of recurrence and improves survival outcomes. Participants will: Receive standard platinum-based adjuvant chemotherapy after surgery or undergo regular postoperative surveillance according to institutional guidelines. Be followed at scheduled intervals with clinical assessments and imaging to monitor for recurrence and survival outcomes.

Conditions

• Non-small Cell Lung Cancer Stage I

Interventions

Type	Name	Description
DRUG	Adjuvant chemotheapy	apply adjuvant chemotheapy

Timeline

• Start date: 2015-01-01
• Primary completion: 2019-12-31
• Completion: 2025-06-01
• First posted: 2025-11-26
• Last updated: 2025-11-26