A Prospective Multicenter Study of the Association Between TCM Syndromes and EGFR-TKI Efficacy in Lung Cancer Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGuangzhou University of Traditional Chinese Medicine

About this trial

The goal of this observational study is to learn about the relationship between TCM body constitution patterns (called "syndromes") and the effectiveness of EGFR-TKI targeted drugs in patients with lung cancer. Approximately 3000 patients with EGFR-mutant non-small cell lung cancer who are about to start or are already taking EGFR-TKI drugs as part of their regular medical care will be invited to join. Participants will be followed for up to 5 years. During routine clinic visits, researchers will collect their TCM information (such as tongue images and pulse readings) and store small samples of their blood, stool, and tongue coating for future research.

Eligibility criteria

Qualifiers

Pathologically or histologically confirmed non-small cell lung cancer (NSCLC)

Age ≥ 18 years

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Presence of epidermal growth factor receptor (EGFR) mutation confirmed by genetic testing

Disqualifiers

Unable to comply with baseline assessments

Pregnant or breastfeeding women

Presence of other uncontrolled malignancies

Presence of severe brain diseases or psychiatric disorders that affect the patient's ability to communicate or provide informed consent

Trial design

Treatments tested in this trial

  • EGFR-TKI

Treatment groups

3,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Guangzhou University of Traditional Chinese Medicine

Lead sponsor

Beijing Chest Hospital

Collaborator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Collaborator

Sichuan Cancer Hospital and Research Institute

Collaborator

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

Collaborator

Affiliated Hospital of Xinxiang Medical University, Henan province

Collaborator