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

Based on Plasma Exosomes Combined With Multi-omics Analysis to Reveal the Trajectory of Targeted Therapy Resistance and Novel Target Intervention Therapy in Patients With EGFR Mutation in Lung Adenocarcinoma

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Lung Adenocarcinoma; EGFR Activating Mutation
• Intervention / Treatment: Other: observational study

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

From January 2021 to December 2026, about 500 patients with EGFR-mutated lung adenocarcinoma who receive targeted therapy with or without chemotherapy as first-line treatment will be included in this cohort study

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Untreated EGFR mutated lung adenocarcinoma patients; Patients diagnosed with lung adenocarcinoma with EGFR mutations for the first time.	Other: observational study; Efficacy of targeted therapy combined with or without chemotherapy as first-line therapy in patients with EGFR-mutated lung adenocarcinoma.
Patients with EGFR-mutated lung adenocarcinoma who are responding to targeted therapy; Patients with EGFR-mutated lung adenocarcinoma treated with targeted therapy combined with or without chemotherapy as first-line therapy, and the therapeutic effect was in the response stage.	Other: observational study; Efficacy of targeted therapy combined with or without chemotherapy as first-line therapy in patients with EGFR-mutated lung adenocarcinoma.
Patients with EGFR-mutated lung adenocarcinoma who are resistant to targeted therapy; Patients with EGFR-mutated lung adenocarcinoma treated with targeted therapy combined with or without chemotherapy as first-line therapy, and the therapeutic effect was in drug resistance stage, or disease progression.	Other: observational study; Efficacy of targeted therapy combined with or without chemotherapy as first-line therapy in patients with EGFR-mutated lung adenocarcinoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival	The time of disease progression is evaluated according to the Response Evaluation Criteria in Solid Tumors, version 1.1.	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	The survival time after receiving targeted therapy combined with or without chemotherapy as first-line treatment	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)

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Collaborators: Yichang Central People's Hospital; Suizhou Hospital, Hubei University of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Estimated): December 12, 2024

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma; Adenocarcinoma of Lung; Adenocarcinoma
• Other Study ID Numbers: XHJY20240912

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No