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.
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
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
This study will enroll approximately 3000 adult patients with EGFR-mutant non-small cell lung cancer (NSCLC) who are initiating standard EGFR-TKI therapy.
Cohort
Prospective
EGFR-TKI
DrugStandard treatment with EGFR tyrosine kinase inhibitors (e.g., gefitinib, erlotinib, osimertinib) for NSCLC. The study observes its association with TCM syndrome patterns.
Progression-Free Survival
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.
Disease-Free Survival
From the date of surgery until the date of first documented tumor recurrence, distant metastasis, or death from any cause, whichever occurs first.
Objective Response Rate
Objective response rate is defined as the proportion of patients achieving complete (CR) or partial (PR) response according to RECIST V.1.1 criteria.
Disease Control Rate
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).
Overall Survival
Overall survival is defined as the time until death due to any cause.
Quality of life evaluation
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.
Traditional Chinese Medicine (TCM) Syndrome Classification
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.
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Guangzhou University of Traditional Chinese Medicine
Lead sponsor
Beijing Chest Hospital
Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborator
Sichuan Cancer Hospital and Research Institute
Collaborator
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
Collaborator
Affiliated Hospital of Xinxiang Medical University, Henan province
Collaborator
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