NCT07338396Not yet recruiting
A Prospective Multicenter Study of the Association Between TCM Syndromes and EGFR-TKI Efficacy in Lung Cancer Patients
A Clinical Study on the Patterns of Traditional Chinese Medicine Syndromes and Efficacy Differences in Lung Cancer Patients Treated With EGFR-TKI
Source: ClinicalTrials.gov · Last updated 13 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 16 Dec 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Jul 2029
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Diseases
- Lung cancer
- NCT number
- NCT07338396
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 1 Jan 2026 to the primary completion date, 31 Jul 2029
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Unable to comply with baseline assessments
- Pregnant or breastfeeding women
- Individuals without legal capacity, or those with medical or ethical reasons preventing continued participation in the study
- Refusal to sign the informed consent form
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Chest Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Guang'anmen Hospital of China Academy of Chinese Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Sichuan Cancer Hospital and Research Institute Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Guangdong Provincial Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Affiliated Hospital of Xinxiang Medical University, Henan province Coordinator of this site? Confirm its status | Weihui | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.