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

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.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer Stage I
• Intervention / Treatment: Drug: Adjuvant chemotheapy

• Study Type: Observational
• Enrollment (Actual): 2072

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with non-squamous NSCLC from four participating hospitals

Description

Inclusion Criteria:

1. Patients must have histologically confirmed non-squamous NSCLC
2. Patients must be ≥18 years of age at the time of diagnosis
3. Pathological stage I disease (T1-2N0M0) according to the AJCC 8th edition (specify if applicable)
4. Patients must have undergone complete surgical resection (R0) with systematic lymph node dissection
5. Surgery performed between January 1, 2015 and December 31, 2019

Exclusion Criteria:

1. Prior history of malignant tumors or presence of synchronous other primary malignancy
2. Multiple primary lung cancers diagnosed at baseline
3. Receipt of any neoadjuvant chemotherapy, radiotherapy, or targeted therapy
4. Perioperative death occurring within 30 days after surgery
5. Incomplete or missing clinical or pathological information
6. Loss to follow-up before the first scheduled surveillance assessment

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adjuvant chemotherapy	Drug: Adjuvant chemotheapy; apply adjuvant chemotheapy
Postoperative Observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-year Disease-Free Survival (DFS), defined as time from surgery to recurrence or death, estimated by Kaplan-Meier method.	DFS is defined as the time from surgery to the first documented recurrence or death from any cause, whichever occurs first. Patients without an event will be censored at the last follow-up. Data will be summarized using Kaplan-Meier survival analysis, with median DFS and 95% confidence intervals.	Up to 5 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-year Recurrence-Free Survival (RFS), defined as time from surgery to the first recurrence or death from any cause, estimated by Kaplan-Meier method	RFS is defined as the time from surgery to the date of first documented tumor recurrence (local, regional, or distant) or death from any cause, whichever occurs first. Patients who are alive and recurrence-free will be censored at the date of last follow-up. Data will be analyzed using Kaplan-Meier survival estimates, with median RFS and 95% confidence intervals reported.	Up to 5 years after surgery.

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: September 28, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: No. 2024-SR-1028 (Other Identifier: Jiangsu Province Hospital)