An observational study in Non Small Cell Lung Cancer NSCLC, sponsored by Guangzhou University of Traditional Chinese Medicine. Not yet recruiting at 6 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by Guangzhou University of Traditional Chinese Medicine · Observational
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.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 160 across 1,148 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Guangzhou University of Traditional Chinese Medicine is the lead sponsor of 58 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study will enroll approximately 3000 adult patients with EGFR-mutant non-small cell lung cancer (NSCLC) who are initiating standard EGFR-TKI therapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Postoperative Cohort (must meet all of the above and the following):
Advanced Cohort (must meet all of the above and the following):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Standard treatment with EGFR tyrosine kinase inhibitors (e.g., gefitinib, erlotinib, osimertinib) for NSCLC. The study observes its association with TCM syndrome patterns.
This study also gives Osimertinib. No intervention listed here names it: that was found by reading the record.
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.
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.
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 (TCM) Syndrome Classification
Tongue and pulse characteristics will be collected using standardized and validated tongue diagnosis and pulse diagnosis devices. Standardized symptom information (e.g., fatigue, poor appetite) will be collected by licensed TCM practitioners. Symptoms will be recorded as present or absent without severity grading. Based on tongue, pulse, and symptom information, TCM practitioners will determine and classify each participant's TCM syndrome pattern (e.g., cold syndrome, heat syndrome) at each assessment time point.
Time frame: At the baseline, every 3 months until disease recurrence/progression or the end of the study, assessed up to 3 years.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →
Guangzhou University of Traditional Chinese Medicine