Association Between RVT and Prognosis After Neoadjuvant Targeted Therapy in EGFR NSCLC

February 20, 2025 updated by: GuiBin Qiao, Guangdong Provincial People's Hospital

Association Between Residual Viable Tumor and Prognosis After Neoadjuvant Targeted Therapy in EGFR-Mutated Non-small Cell Lung Cancer

EGFR-mutated NSCLC is a distinct subtype that responds well to targeted therapies. Neoadjuvant targeted therapy aims to downstage tumors and improve surgical outcomes, but the prognostic role of residual viable tumor (RVT) remains unclear. This retrospective study examines the association between RVT and survival outcomes. The findings will further validate the importance of RVT as a surrogate.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Non-small cell lung cancer (NSCLC) with EGFR mutations represents a molecularly distinct subset of lung cancer that benefits from targeted therapies. Neoadjuvant targeted therapy has emerged as a promising approach for locally advanced NSCLC, aiming to achieve tumor downstaging and improve surgical outcomes. However, the prognostic significance of residual viable tumor (RVT) after neoadjuvant targeted therapy remains poorly understood. This retrospective study investigates the association between the percentage of RVT and survival outcomes in EGFR-mutated NSCLC patients following neoadjuvant targeted therapy. Specific survival outcomes were disease-free survival (DFS) and event-free survival (EFS). By highlighting RVT as a critical prognostic biomarker, the findings provide actionable insights for optimizing postoperative management and stratifying high-risk patients. This work underscores the need for pathological evaluation of RVT to refine prognosis and treatment strategies.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:

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 EGFR-mutant NSCLC who received neoadjuvant targeted therapy followed by definitive surgery.

Description

Inclusion Criteria:

  • Age 18-80 years old;
  • Pathologically diagnosed EGFR-mutated non-small cell lung cancer (NSCLC);
  • Treated with neoadjuvant targeted therapy;
  • Undergoing definitive surgery.

Exclusion Criteria:

  • A history of prior chemotherapy, immunotherapy, or radiotherapy.
  • A history of malignancy or lung surgery;
  • Missing key data.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival (DFS)
Time Frame: Disease-free survival (DFS) was defined as the time from the date of surgery to the date of recurrence or last follow-up. Estimated final follow-up is 3 years postoperatively.
Disease-free survival (DFS) was defined as the time from the date of surgery to the date of recurrence or last follow-up.
Disease-free survival (DFS) was defined as the time from the date of surgery to the date of recurrence or last follow-up. Estimated final follow-up is 3 years postoperatively.
Event-free survival (EFS)
Time Frame: Event-free survival (EFS) was defined as the time from the date of diagnosis to the date of first event (relapse or death) or last follow-up. Estimated final follow-up is 3 years postoperatively.
Event-free survival (EFS) was defined as the time from the date of diagnosis to the date of first event (relapse or death) or last follow-up.
Event-free survival (EFS) was defined as the time from the date of diagnosis to the date of first event (relapse or death) or last follow-up. Estimated final follow-up is 3 years postoperatively.

Collaborators and Investigators

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

Sponsor

Guangdong Provincial People's Hospital

Investigators

  • Principal Investigator: Guibin Qiao, Guangdong Provincial People's Hospital

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)

February 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

January 8, 2025

First Submitted That Met QC Criteria

January 8, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RVT-LUNG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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