Non Small Cell Lung Cancer NSCLCNCT07338396
A Prospective Multicenter Study of the Association Between TCM Syndromes and EGFR-TKI Efficacy in Lung Cancer Patients
An observational study of Non Small Cell Lung Cancer NSCLC, run by Guangzhou University of Traditional Chinese Medicine at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer NSCLC
- What is being tested?
- EGFR-TKI
- Type of treatment
- Injection or infusion
- How many people
- 3,000 participants
- Where
- 6 sitesChina
- Study dates
- Jan 2026to Jul 2031
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites
Beijing chest Hospital
Beijing, Beijing Municipality, 100000
Ying Hu, 86-010-89509324, huying@bjxkyy.en
Guang'anmen Hospital of china Academy of chinese Medical Sciences
Beijing, Beijing Municipality, 100000
Ying Zhang, 86-010-83123311, zylzy501@163.com
Kainan Zhou, 86-010-83123311, zhoukn21@163.com
Sichuan Cancer Hospital and Research Institute
Chengdu, Sichuan, 610040
Wei Dai, 86-020-85420366, davii-i@126.com
Jia Liao, 86-020-85420366, 709524124@qq.com
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510000
Lina Ding, 86-020-81887233, 2804138491@qq.com
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
Shanghai, Shanghai Municipality, 200437
DI Zhou, 86-021-65162628, judy_36zzzzz@126.com
Affiliated Hospital of Xinxiang Medical University, Henan province
Weihui, Henan
Xiaohong Kang, 86-0373-4403114, kxhhgd@163.com
About this study
Official title: A Clinical Study on the Patterns of Traditional Chinese Medicine Syndromes and Efficacy Differences in Lung Cancer Patients Treated With EGFR-TKI
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
- Being tested
- EGFR-TKI
- Keywords
- Non Small Cell Lung Cancer NSCLC, Traditional Chinese Medicine Syndromes, Efficacy, EGFR-TKI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: EGFR-TKI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Objective response rate is defined as the proportion of patients achieving complete (CR) or partial (PR) response according to RECIST V.1.1 criteria.
Measured: 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).
Measured: Through study completion, an average of 3 years.
Overall Survival
Overall survival is defined as the time until death due to any cause.
Measured: 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.
Measured: 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.
Measured: At the baseline, every 3 months until disease recurrence/progression or the end of the study, assessed up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung Cancer NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chest Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Sichuan Cancer Hospital and Research Institute, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Affiliated Hospital of Xinxiang Medical University, Henan province
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338396
- Sponsor's protocol ID
- 2025ZD0544601
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Patterns of Traditional Chinese Medicine Syndromes and Efficacy Differences in Lung Cancer Patients Treated With EGFR-TKI
- ClinicalTrials.gov ID
- NCT07338396
- Acronym / sponsor ID
- 2025ZD0544601
- Conditions
- Non Small Cell Lung Cancer NSCLC
- Keywords
- Non Small Cell Lung Cancer NSCLC, Traditional Chinese Medicine Syndromes, Efficacy, EGFR-TKI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Beijing Chest Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Sichuan Cancer Hospital and Research Institute, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Affiliated Hospital of Xinxiang Medical University, Henan province
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced Cohort | – | Drug: EGFR-TKIParticipants 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. |
| Postoperative Cohort | – | Drug: EGFR-TKIParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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
- Have undergone curative surgery for lung cancer with R0 resection
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EGFR-TKIStandard treatment with EGFR tyrosine kinase inhibitors (e.g., gefitinib, erlotinib, osimertinib) for NSCLC. The study observes its association with TCM syndrome patterns. | Drug | Advanced Cohort, Postoperative Cohort |
Primary outcome
Progression-Free Survival
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.
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
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.
From the date of surgery until the date of first documented tumor recurrence, distant metastasis, or death from any cause, whichever occurs first.
5 secondary outcomes
Objective Response Rate
Time frame: Through study completion, an average of 3 years.
Disease Control Rate
Time frame: Through study completion, an average of 3 years.
Overall Survival
Time frame: From the date of randomization until the date of death from any cause, assessed up to 5 years.
Quality of life evaluation
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
Time frame: At the baseline, every 3 months until disease recurrence/progression or the end of the study, assessed up to 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer NSCLC, run by Guangzhou University of Traditional Chinese Medicine at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lina Ding (86-020-81887233, 2804138491@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.