NCT06771960

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

10 months

First QC Date

January 8, 2025

Last Update Submit

February 20, 2025

Conditions

Keywords

lung cancerNeoadjuvant targeted therapyresidual viable tumorprognosisEGFR-Mutated

Outcome Measures

Primary Outcomes (2)

  • 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.

    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)

    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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Guibin Qiao

    Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

January 8, 2025

First Posted

January 13, 2025

Study Start

February 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 30, 2025

Last Updated

February 21, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations