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

November 24, 2025 updated by: The First Affiliated Hospital with Nanjing Medical University

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2072

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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.
Time Frame: Up to 5 years after surgery
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
Time Frame: Up to 5 years after surgery.
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

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • No. 2024-SR-1028 (Other Identifier: Jiangsu Province Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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