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

NCT07250360 | Completed

• 1 other identifier: No. 2024-SR-1028
• Study Type: observational
• Target: 2,072
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

  Up to 5 years after surgery.

Study Arms (2)

Adjuvant chemotherapy

Drug: Adjuvant chemotheapy

Postoperative Observation

Interventions

Adjuvant chemotheapy DRUG

apply adjuvant chemotheapy

Adjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with non-squamous NSCLC from four participating hospitals

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: November 26, 2025
• Study Start: January 1, 2015
• Primary Completion: December 31, 2019
• Study Completion: June 1, 2025
• Last Updated: November 26, 2025

Record last verified: 2024-02