IASLC Grading System as a Predictor for EGFR-TKI Therapy

Completed

• Conditions: Lung Cancer

• Registration Number: NCT06131645
• Lead Sponsor: Fudan University

Brief Summary

The investigators previously validated the grading system proposed by International Association for the Study of Lung Cancer (IASLC) for invasive nonmucinous lung adenocarcinoma (LADC) for its reproducibility, prognostication function and predictive value of adjuvant chemotherapy (ACT). In this exploratory study, the investigators aimed to investigate the role of IASLC grading system in EGFR tyrosine kinase inhibitor (TKI) therapy selection either as adjuvant or palliative therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-07-01
• Study First Submitted: 2023-11-09
• Study First Submitted QC: 2023-11-09
• Study First Posted: 2023-11-14
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2160

Inclusion Criteria

• invasive lung adenocarcinoma patients who underwent complete resection with positive EGFR mutations in exons 18-21.

Exclusion Criteria

• adenocarcinoma in situ (AIS), minimally invasive adenocarcinoma (MIA), invasive mucinous adenocarcinoma and other variants of adenocarcinoma
• patients with pathologic slides unavailable for re-evaluation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival	5 years	PFS was defined as time from initiation of systemic palliative treatment to date of disease progression or death for 1L treatment of each patient and the initiation time was re-assigned additionally for each drug applied during the treatment history of the patients regardless of line of therapy (all lines)
Disease-free survival	5 years	DFS was defined as time from initiation of surgery to date of first event (recurrence or death)

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years	was defined as time from surgery to date of death resulting from any cause in ADJUVANT subgroup and from 1L systemic palliative treatment assignment to date of death resulting from any cause in RECURRENCE subgroup.

Trial Locations

Locations (1)

Chaoqiang Deng; 🇨🇳 Shanghai, Please Select, China