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Not yet recruiting NCT07338396

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

— Observational Non Small Cell Lung Cancer NSCLC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EGFR-TKI.
Who it may be relevant to
Registry conditions: Non Small Cell Lung Cancer NSCLC. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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.]
  • 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.]
Secondary outcome measures (5)
  • Objective Response Rate [Time frame: Through study completion, an average of 3 years.]
  • Disease Control Rate [Time frame: 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.]
  • 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.]
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 6 centers
  • Beijing chest Hospital — Beijing
  • Guang'anmen Hospital of china Academy of chinese Medical Sciences — Beijing
  • Guangdong Provincial Hospital of Traditional Chinese Medicine — Guangzhou
  • Affiliated Hospital of Xinxiang Medical University, Henan province — Weihui
  • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine — Shanghai
  • Sichuan Cancer Hospital and Research Institute — Chengdu

Identifiers

NCT: NCT07338396 · 2025ZD0544601

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗