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NCT Number: NCT07338396

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

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.

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Key information

Conditions

Non Small Cell Lung Cancer NSCLC

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing chest Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EGFR-TKI

Drug

Standard treatment with EGFR tyrosine kinase inhibitors (e.g., gefitinib, erlotinib, osimertinib) for NSCLC. The study observes its association with TCM syndrome patterns.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lina Ding

CONTACT

[email protected]

86-020-81887233

Yanjuan Zhu, MD

CONTACT

[email protected]

86-020-81887233

Sponsors and collaborators

Lead sponsor

Guangzhou University of Traditional Chinese Medicine

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2031
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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