Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06730477

Plasma Exosomes Reveal the Efficacy of Targeted 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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Lung Adenocarcinoma Adenocarcinoma Adenocarcinoma of Lung Carcinoma EGFR Activating Mutation Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Union hospital, Tongji Medical college, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observational study

Other

Efficacy of targeted therapy combined with or without chemotherapy as first-line therapy in patients with EGFR-mutated lung adenocarcinoma.

Primary outcomes

  1. progression-free survival

    Time frame: 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 outcomes

  1. Overall survival

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Other

Collaborators

  • Suizhou Hospital, Hubei University of Medicine
  • Yichang Central People's Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Dec 12, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.