A Prospective Multicenter Study of the Association Between TCM Syndromes and EGFR-TKI Efficacy in Lung Cancer Patients
NCT ID: NCT07338396
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
3000 participants
OBSERVATIONAL
2026-01-31
2031-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Beijing Chest Hospital
OTHER
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
OTHER
Sichuan Cancer Hospital and Research Institute
OTHER
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
UNKNOWN
Affiliated Hospital of Xinxiang Medical University, Henan province
UNKNOWN
Guangzhou University of Traditional Chinese Medicine
OTHER
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025ZD0544601
Identifier Type: -
Identifier Source: org_study_id
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