IASLC Grading System as a Predictor for EGFR-TKI Therapy

• Sponsor: Fudan University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06131645
• Collaborator: (none)
• Enrollment: 2,160
• Location: 1
• Actual Duration (Months): 29.9
• Patients Per Site Per Month: 72.2

Study Details

Study Description

Brief Summary

We 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, we aimed to investigate the role of IASLC grading system in EGFR tyrosine kinase inhibitor (TKI) therapy selection either as adjuvant or palliative therapy.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Diagnostic Test: IASLC grading system

Study Design

• Study Type: Observational
• Actual Enrollment: 2160 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: The IASLC Grading System as a Predictor for EGFR-TKI Therapy in EGFR-mutant Lung Adenocarcinoma
• Actual Study Start Date: Jan 1, 2021
• Actual Primary Completion Date: Dec 31, 2022
• Actual Study Completion Date: Jul 1, 2023

Outcome Measures

Primary Outcome Measures

1. Disease-free survival [5 years]

   DFS was defined as time from initiation of surgery to date of first event (recurrence or death)

2. 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)

Secondary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chaoqiang Deng	Shanghai	Please Select	China	200032

Sponsors and Collaborators

• Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Haiquan Chen, Director in the Department of Thoracic Surgery, FUSCC, Fudan University
• ClinicalTrials.gov Identifier: NCT06131645
• Other Study ID Numbers: GRADS-TKI
• First Posted: Nov 14, 2023
• Last Update Posted: Nov 14, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 14, 2023