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

January 5, 2026 updated by: Guangzhou University of Traditional Chinese Medicine

A Clinical Study on the Patterns of Traditional Chinese Medicine Syndromes and Efficacy Differences in Lung Cancer Patients Treated With EGFR-TKI

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100000
        • Beijing Chest Hospital
        • Contact:
      • Beijing, Beijing Municipality, China, 100000
        • Guang'anmen Hospital of China Academy of Chinese Medical Sciences
        • Contact:
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Guangdong Provincial Hospital of Traditional Chinese Medicine
        • Contact:
    • Henan
      • Weihui, Henan, China
        • Affiliated Hospital of Xinxiang Medical University, Henan province
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200437
        • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610040
        • Sichuan Cancer Hospital and Research Institute
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will enroll approximately 3000 adult patients with EGFR-mutant non-small cell lung cancer (NSCLC) who are initiating standard EGFR-TKI therapy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Advanced Cohort
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.
Drug: EGFR-TKI
Standard treatment with EGFR tyrosine kinase inhibitors (e.g., gefitinib, erlotinib, osimertinib) for NSCLC. The study observes its association with TCM syndrome patterns.
Postoperative Cohort
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.
Drug: EGFR-TKI
Standard treatment with EGFR tyrosine kinase inhibitors (e.g., gefitinib, erlotinib, osimertinib) for NSCLC. The study observes its association with TCM syndrome patterns.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Progress free survival defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Disease-Free Survival
Time Frame: From the date of surgery until the date of first documented tumor recurrence, distant metastasis, or death from any cause, assessed up to 5 years.
From the date of surgery until the date of first documented tumor recurrence, distant metastasis, or death from any cause, whichever occurs first.
From the date of surgery until the date of first documented tumor recurrence, distant metastasis, or death from any cause, assessed up to 5 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: Through study completion, an average of 3 years.
Objective response rate is defined as the proportion of patients achieving complete (CR) or partial (PR) response according to RECIST V.1.1 criteria.
Through study completion, an average of 3 years.
Disease Control Rate
Time Frame: Through study completion, an average of 3 years.
Disease control rate is determined by the percentage of patients who achieve CR, PR, or SD as defined by RECIST V.1.1 criteria. This encompasses all instances of CR, PR, and SD (CR + PR + SD).
Through study completion, an average of 3 years.
Overall Survival
Time Frame: From the date of randomization until the date of death from any cause, assessed up to 5 years.
Overall survival is defined as the time until death due to any cause.
From the date of randomization until the date of death from any cause, assessed up to 5 years.
Quality of life evaluation
Time Frame: At the baseline, every 3 months until disease recurrence/progression or the end of the study, assessed up to 3 years.
According to the requirements of European Organisation for Research and Treatment of Cancer-quality of life core questionnaire (EORTC QLQ-C30)/Lung cancer 29 items (LC 29), the scoring results of each field of the scale were recorded in CRF. The score of this questionnaire ranges between 1 and 4. The higher score indicates the worse quality of life.
At the baseline, every 3 months until disease recurrence/progression or the end of the study, assessed up to 3 years.
Traditional Chinese Medicine Symptom Assessment
Time Frame: At the baseline, every 3 months until disease recurrence/progression or the end of the study, assessed up to 3 years.
According to the requirements of the MDASI-TCM scale, the scores of each domain were recorded in the CRF. Each item is rated on a numeric scale ranging from 0 to 10, with higher scores indicating greater symptom severity or symptom interference.
At the baseline, every 3 months until disease recurrence/progression or the end of the study, assessed up to 3 years.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Traditional Chinese Medicine (TCM) Syndrome Classification
Time Frame: At the baseline, every 3 months until disease recurrence/progression or the end of the study, assessed up to 3 years.
Tongue and pulse characteristics will be collected using standardized and validated tongue diagnosis and pulse diagnosis devices. Standardized symptom information (e.g., fatigue, poor appetite) will be collected by licensed TCM practitioners. Symptoms will be recorded as present or absent without severity grading. Based on tongue, pulse, and symptom information, TCM practitioners will determine and classify each participant's TCM syndrome pattern (e.g., cold syndrome, heat syndrome) at each assessment time point.
At the baseline, every 3 months until disease recurrence/progression or the end of the study, assessed up to 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou University of Traditional Chinese Medicine

Collaborators

Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing Chest Hospital
Sichuan Cancer Hospital and Research Institute
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
Affiliated Hospital of Xinxiang Medical University, Henan province

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2031

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025ZD0544601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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