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

Starting soon

Conditions studied: Non Small Cell Lung Cancer NSCLC

In brief

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.

Key facts

Study ID

NCT07338396

Run by

Guangzhou University of Traditional Chinese Medicine

People needed

3000

Starts

2026-01-01

Expected to finish

2031-07-01

Last updated by the study team

2026-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Postoperative Cohort (must meet all of the above and the following):
• Have undergone curative surgery for lung cancer with R0 resection
• Are planned to receive or are currently receiving postoperative EGFR-TKI adjuvant therapy within 2 weeks
• Advanced Cohort (must meet all of the above and the following):
• Meet stage IIIB-IV criteria according to the 9th edition of the American Joint Committee on Cancer (AJCC), or have stage IIIB or below disease but have refused or are unable to tolerate surgical treatment
• Have at least one measurable lesion
• Are planned to receive or are currently receiving first-line EGFR-TKI therapy within 2 weeks

You may not qualify if…

• 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
• Individuals without legal capacity, or those with medical or ethical reasons preventing continued participation in the study
• Refusal to sign the informed consent form

Where it is running

• Beijing chest Hospital — Beijing, Beijing Municipality, China
• Guang'anmen Hospital of china Academy of chinese Medical Sciences — Beijing, Beijing Municipality, China
• Guangdong Provincial Hospital of Traditional Chinese Medicine — Guangzhou, Guangdong, China
• Affiliated Hospital of Xinxiang Medical University, Henan province — Weihui, Henan, China
• Yueyang Hospital of Integrated Traditional Chinese and Western Medicine — Shanghai, Shanghai Municipality, China
• Sichuan Cancer Hospital and Research Institute — Chengdu, Sichuan, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.