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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Progression-Free Survival — 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.
• Disease-Free Survival — 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.

Trial sites (6)

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