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

Recruiting

• Conditions: Lung Cancer (NSCLC)

• Registration Number: NCT06771960
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-08
• Study First Posted: 2025-01-13
• Status Verified: 2025-02
• Study Start: 2025-02-01
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival (DFS)	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.
Event-free survival (EFS)	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.

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China