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

Guangzhou University of Traditional Chinese Medicine

Status: Not yet enrolling

Conditions: Non Small Cell Lung Cancer NSCLC

Treatments: Drug: EGFR-TKI

Study type: Observational

Funder types: Other

Identifiers

NCT07338396

2025ZD0544601

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

3,000 participants in 2 patient groups

Advanced Cohort

Description:

Participants in this cohort are patients with stage IIIb-IV non-small cell lung cancer (NSCLC) harboring an EGFR sensitizing mutation, who are receiving or are planned to receive first-line EGFR-TKI therapy within 2 weeks as their first-line treatment.

Treatment:

Drug: EGFR-TKI

Postoperative Cohort

Description:

Participants in this cohort are patients who have undergone complete surgical resection (R0) for NSCLC with an EGFR sensitizing mutation and who are receiving or are planned to receive adjuvant EGFR-TKI therapy within 2 weeks as their postoperative treatment.

Treatment:

Drug: EGFR-TKI