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

Huazhong University of Science and Technology

Status: Invitation-only

Conditions: EGFR Activating Mutation; Lung Adenocarcinoma

Treatments: Other: observational study

Study type: Observational

Funder types: Other

Identifiers

NCT06730477

XHJY20240912

Details and patient eligibility

About

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.

Full description

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

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 3 patient groups

Untreated EGFR mutated lung adenocarcinoma patients

Description:

Patients diagnosed with lung adenocarcinoma with EGFR mutations for the first time.

Treatment:

Other: observational study

Patients with EGFR-mutated lung adenocarcinoma who are responding to targeted therapy

Description:

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.

Treatment:

Other: observational study

Patients with EGFR-mutated lung adenocarcinoma who are resistant to targeted therapy

Description:

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.

Treatment:

Other: observational study