Clinical trial NCT06771960: Association Between RVT and Prognosis After Neoadjuvant Targeted Therapy in EGFR NSCLC
Official title: Association Between Residual Viable Tumor and Prognosis After Neoadjuvant Targeted Therapy in EGFR-Mutated Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer (NSCLC)
Keywords: lung cancer
Neoadjuvant targeted therapy
residual viable tumor
prognosis
EGFR-Mutated
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with EGFR-mutant NSCLC who received neoadjuvant targeted therapy followed by definitive surgery.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: 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.
measure: Event-free survival (EFS)
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Guibin Qiao
role: PRINCIPAL_INVESTIGATOR
References: