Plasma Exosomes Reveal the Efficacy of Targeted Therapy in Patients With EGFR Mutation in Lung Adenocarcinoma

• Conditions: Lung Adenocarcinoma; EGFR Activating Mutation

• Registration Number: NCT06730477
• Lead Sponsor: Wuhan Union Hospital, China

Brief Summary

The objective of this observational study is to explore the therapeutic trajectory of targeted therapy in lung adenocarcinoma patients with epidermal growth factor receptor (EGFR) mutations. The main objective is to identify potential biomarkers that can predict the efficacy of targeted therapy through plasma exosomes and to explore strategies to reverse drug resistance to targeted therapy. Biological specimens and medical imaging data will be collected from patients already receiving targeted therapy as a first-line treatment, and followed-up will be conducted to analyze prognosis based on different patterns.

Detailed Description

The medical imaging data will be collected retrospectively and prospectively, and the blood samples and tumor tissues will be collected prospectively.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2024-09-12
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-11
• Last Update Submitted: 2024-12-11
• Study First Posted: 2024-12-12
• Last Update Posted: 2024-12-12
• Primary Completion: 2026-12-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Pathological examination confirmed lung adenocarcinoma
• No other type of tumor was present
• Common sensitive EGFR (Ex19Del L858R or combined with other sites) mutations have been identified
• Receive targeted therapy with or without chemotherapy as first-line treatment
• ≥ 18 years and ≤80 years old

Exclusion Criteria

• History of other malignant tumors
• Irregular treatment or poor compliance
• Incomplete clinical information or lost to follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
progression-free survival	A two-year period after starting treatment (Regular follow-up every three months after receiving targeted therapy combined with or without chemotherapy as first-line treatment)	The time of disease progression is evaluated according to the Response Evaluation Criteria in Solid Tumors, version 1.1.

Secondary Outcome Measures

Name	Time	Method
Overall survival	A three-year period after starting treatment (Regular follow-up every six months after receiving targeted therapy combined with or without chemotherapy as first-line treatment)	The survival time after receiving targeted therapy combined with or without chemotherapy as first-line treatment

Trial Locations

Locations (1)

Union hospital, Tongji Medical college, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China