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

NCT07338396 | Not Yet Recruiting DMC

• 1 other identifier: 2025ZD0544601
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Non Small Cell Lung Cancer NSCLC

Keywords

Non Small Cell Lung Cancer NSCLC; Traditional Chinese Medicine Syndromes; Efficacy; EGFR-TKI

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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 (5)

• Objective Response Rate

  Through study completion, an average of 3 years.

• Disease Control Rate

  Through study completion, an average of 3 years.

• Overall Survival

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

• Quality of life evaluation

  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

  At the baseline, every 3 months until disease recurrence/progression or the end of the study, assessed up to 3 years.

Other Outcomes (1)

• Traditional Chinese Medicine (TCM) Syndrome Classification

  At the baseline, every 3 months until disease recurrence/progression or the end of the study, assessed up to 3 years.

Study Arms (2)

Advanced Cohort

Participants in this cohort are patients with stage IIIb-IV non-small cell lung cancer (NSCLC) harboring an EGFR sensitizing mutation, who are receiving or are planned to receive first-line EGFR-TKI therapy within 2 weeks as their first-line treatment.

Drug: EGFR-TKI

Postoperative Cohort

Participants in this cohort are patients who have undergone complete surgical resection (R0) for NSCLC with an EGFR sensitizing mutation and who are receiving or are planned to receive adjuvant EGFR-TKI therapy within 2 weeks as their postoperative treatment.

Drug: EGFR-TKI

Interventions

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.

Advanced Cohort; Postoperative Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll approximately 3000 adult patients with EGFR-mutant non-small cell lung cancer (NSCLC) who are initiating standard EGFR-TKI therapy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead
• 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

Study Sites (6)

Beijing chest Hospital

Beijing, Beijing Municipality, 100000, China

Location

Guang'anmen Hospital of china Academy of chinese Medical Sciences

Beijing, Beijing Municipality, 100000, China

Location

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, 510000, China

Location

Affiliated Hospital of Xinxiang Medical University, Henan province

Weihui, Henan, China

Location

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

Shanghai, Shanghai Municipality, 200437, China

Location

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, 610040, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood plasma; Peripheral Blood Mononuclear Cells (PBMCs); Fecal specimens; Tongue coating specimens

Central Study Contacts

Lina Ding

CONTACT

86-020-81887233; 2804138491@qq.com

Yanjuan Zhu, MD

CONTACT

86-020-81887233; zyjsophy@gzucm.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 13, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2031
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

CN (6)