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

N/ANot Yet RecruitingNCT07338396

Guangzhou University of Traditional Chinese Medicine3,000 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Non Small Cell Lung Cancer NSCLC

Interventions

EGFR-TKIDRUG

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

Eligibility

Medical Language ↔ Plain English

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

Locations (6)

Beijing chest Hospital

Beijing, Beijing Municipality, China

Guang'anmen Hospital of china Academy of chinese Medical Sciences

Beijing, Beijing Municipality, China

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Affiliated Hospital of Xinxiang Medical University, Henan province

Weihui, Henan, China

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

Shanghai, Shanghai Municipality, China

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

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.

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

From the date of surgery until the date of first documented tumor recurrence, distant metastasis, or death from any cause, whichever occurs first.

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 Outcomes

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.

Time frame: Through study completion, an average of 3 years.

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).

Time frame: Through study completion, an average of 3 years.

Overall Survival

Overall survival is defined as the time until death due to any cause.

Time frame: From the date of randomization until the date of death from any cause, assessed up to 5 years.

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.

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

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.