NSCLC, Stage IADDRESSNCT04830826
A Real-world Study of Adjuvant Therapy in Early Stage NSCLC With EGFR Mutation-Positive in China
An observational study of NSCLC, Stage I and NSCLC, Stage II, run by The First Affiliated Hospital of Guangzhou Medical University at 51 sites in China.
Trial summary
This study is a prospective, national, multi-center, non-interventional study. The main purpose is to explore the initial adjuvant treatment pattern after radical resection for early-stage NSCLC patients with EGFR Mutation-Positive in the real world. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- NSCLC, Stage I, NSCLC, Stage II, NSCLC, Stage III
- What is being tested?
- Surgeries
- Type of treatment
- Surgery or procedure
- How many people
- 1,490 participants
- Where
- 51 sitesChina
- Study dates
- 9 Jul 2020to 7 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Continuously enroll all patients with early-stage (stage I-III), histopathologically confirmed, and EGFR mutation-positive NSCLC after R0 resection
Who may be able to join
- Informed consent signed;
- Newly confirmed EGFR Mutation-Positive NSCLC confirmed by histopathology except for cytology;
- Receiving or not receiving neoadjuvant treatment before surgery;
- Patients with stage I-III NSCLC undergo confirmed radical R0 resection;
Who cannot join
- Patients who currently or have previously participated in any other anti-tumor clinical studies;
- Patients with NSCLC who have received any systemic anti-cancer therapy as the main treatment in the past. Cytotoxic therapy, targeted therapy (tyrosine kinase inhibitors or monoclonal antibodies) and immunotherapy included except for the use of neoadjuvant therapy;
- Patients who have received adjuvant therapy before enrollment.
- Patients with stage I-III NSCLC whose surgical resection cannot be confirmed.
- Patients assessed by the investigator as unfit for enrollment, such as neurological disorders or metabolic disorders, physical examination or laboratory examination suspected that the patient has a possible disease, or has contraindications to the use of study drugs, or has treatment-related complications High risk etc.
Trial locations and contacts
51 sites in 1 country.
51 sites in 1 country
China51 sites
Anyang Tumour Hospital
Anyang, Henan, 455000
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100000
Beijing Chest Hospital，Capital Medical university
Beijing, Beijing Municipality, 100000
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
Peking University People'S Hospital
Beijing, Beijing Municipality, 100000
Peking University Third Hospital
Beijing, Beijing Municipality, 100000
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100000
Cangzhou Central Hospital
Cangzhou, Hebei, 061000
Bethune first hospital of jilin university
Changchun, Jilin, 130000
China-Japan Union Hospital of JiLin University
Changchun, Jilin, 130000
Xiangya Hospital Central South University
Changsha, Hunan, 410000
West China Hospital of Sichuan University
Chengdu, Sichuang, 610000
Affiliated Hospital of Chifeng University
Chifeng, Neimenggu, 24000
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400000
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116000
Fujian Provincial Hospital
Fuzhou, Fujian, 350000
Cancer Center of Guangzhou Medical university
Guangzhou, Guangdong, 510000
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510000
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, 510000
Sir Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
The first affiliated hospital zhejiang university
Hangzhou, Zhejiang, 310000
The Second Affiliated hospital of Zhejiang University Achool of Medical
Hangzhou, Zhejiang, 310000
Zhejiang cancer hospital
Hangzhou, Zhejiang, 310000
The Affliated of Inner Mongolia Medical University
Hohhot, Neimenggu, 010000
Qilu Hospital of Shandong Yniversity
Jinan, Shandong, 250000
Shandong Cancer Hospital
Jinan, Shandong, 250000
The Affliated of Southwest Medical University
Luzhou, Sichuang, 646000
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, 330000
Jiangsu Province Hospital
Nanjing, Jiangsu, 210000
The second affiliated hospital of guangxi medical university
Nanning, Guangxi, 530000
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315000
Shanghai Jiaotong University Medical College Affiliated Ruijin hospital
Shanghai, Shanghai Municipality, 200000
Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200000
ZhongShan Hospital
Shanghai, Shanghai Municipality, 200000
Shaoxing People's Hospital
Shaoxing, Zhejiang, 312000
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110000
The First Hospital of China Medical University
Shenyang, Liaoning, 110000
Shenzhen People's Hospital
Shenzhen, Guangdong, 518000
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 50000
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215000
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030000
Taizhou Hospita of Zhejiang Province
Taizhou, Zhejiang, 318000
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300000
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300000
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524000
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000
PKUCare Luzhong Hospital
Zibo, Shangdong, 255000
About this study
Official title: A Prospective, National, Multi-center, Non-intervention Real-world Study of Adjuvant Therapy in Early Stage NSCLC With EGFR Mutation-Positive in China
This study is a prospective, national, multi-center, non-interventional study. The main purpose is to explore the initial adjuvant treatment pattern after radical resection for early-stage NSCLC patients with EGFR Mutation-Positive in the real world. The secondary purpose was to observe the postoperative follow-up treatment pattern and its subgroups (based on different EGFR mutation status and different clinical stages).
Read the detailed description
About 2,000 eNSCLC patients who received radical resection from about 50 research centers across the country will be included in this study, and will be followed up to 2 years after enrollment according to the actual clinical situation. The analysis method of this study is mainly based on descriptive statistics. The information about the human genetic resources of the subjects to be collected includes: demography, physical examination, WHO fitness status, medical history, smoking history, disease characteristics, surgical information, initial and follow-up adjuvant treatment pattern, laboratory tests, survival status, and adverse events related to gefitinib/osimertinib, serious adverse events/non-severe ADR, measures taken for adverse events, outcome of adverse events.
- Conditions
- NSCLC, Stage I, NSCLC, Stage II, NSCLC, Stage III
- Being tested
- Surgeries
- Keywords
- EGFR Mutation, NSCLC, Adjuvant Therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeriesProcedure or surgery
Surgeries
What is being measured
The primary outcome is the main question the study is designed to answer.
The distribution of participants with initial adjuvant treatment pattern after radical resection surgery for early-stage NSCLC patients
Descriptive summary statistics ( total number of cases, number of missing cases, frequency, and percentage of each category) were used to describe the distribution of participants with initial adjuvant treatment patterns, including chemical, targeted, combined, or other therapy.
Set subgroup analysis for different initial adjuvant treatment pattern, including different clinical stages (according to phase I/ Phase II/ stage III) and different EGFR mutation status (19del or 21 L858R);
Measured: 2 years
Time on initial adjuvant treatment
Calculate the time from the start date to the end of initial adjuvant treatment. The total number of cases, number of missing cases, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum were used for statistical description.
Measured: 2 years
The interval from the date of operation to the start date of initial adjuvant therapy with EGFR-TKI.
Calculate the interval of operation to the adjuvant therapy with EGFR-TKI, which is classified into single-drug therapy and combined therapy. The total number of cases, number of missing cases, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum were used for statistical description.
Measured: 2 years
Numbers of therapy cycles of initial adjuvant treatment
The patients with chemotherapy were mainly calculated, divided into chemotherapy and targeted combination chemotherapy. The total number of chemotherapy cycles, the number of missing cases, the mean, standard deviation, the median, the 25th and 75th percentiles, the minimum and the maximum were statistically described
Measured: 2 years
Secondary outcomes (4)
The distribution of participants with follow-up treatment pattern after initial adjuvant treatment.
Descriptive summary statistics ( total number of cases, number of missing cases, frequency, and percentage of each category) were used to describe the distribution of participants with follow-up treatment patterns after advanced events evaluated by an investigator, including chemical, targeted, combined, or other therapy.
Set subgroup analysis for different follow-up treatment pattern including different clinical stages (according to phase I/ Phase II/ stage III) and different EGFR mutation status (19del or 21 L858R);
Measured: 2 years
Time on follow-up treatment
Calculate the time from the start date to the end of follow-up treatment. The results are shown in months, to one decimal place. The total number of cases, number of missing cases, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum were used for statistical description.
Measured: 2 years
The interval from the date of operation to the start date of the follow-up treatment with EGFR-TKI.
Calculate the interval of operation to the follow-up treatment with EGFR-TKI, which is classified into single-drug therapy and combined therapy. The results are shown in months, to one decimal place. The total number of cases, number of missing cases, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum were used for statistical description.
Measured: 2 years
Numbers of therapy cycles of follow-up treatment
The patients with chemotherapy of follow-up treatment were mainly calculated, divided into chemotherapy and targeted combination chemotherapy. The total number of chemotherapy cycles, the number of missing cases, the mean, standard deviation, the median, the 25th and 75th percentiles, the minimum and the maximum were statistically described
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start9 Jul 2020
- Primary completion8 Jul 2024
- Study completion7 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC, Stage IStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- 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
- 1,490 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- jianxing He, President, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830826
- Sponsor's protocol ID
- D7913C00727
- Acronym
- ADDRESS
- Status last verified
- Jul 2025
- First submitted
- 24 Mar 2021
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, National, Multi-center, Non-intervention Real-world Study of Adjuvant Therapy in Early Stage NSCLC With EGFR Mutation-Positive in China
- ClinicalTrials.gov ID
- NCT04830826
- Acronym / sponsor ID
- ADDRESS / D7913C00727
- Conditions
- NSCLC, Stage I, NSCLC, Stage II, NSCLC, Stage III
- Keywords
- EGFR Mutation, NSCLC, Adjuvant Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,490 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 5 Apr 2021 (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.
This study is a prospective, national, multi-center, non-interventional study. The main purpose is to explore the initial adjuvant treatment pattern after radical resection for early-stage NSCLC patients with EGFR Mutation-Positive in the real world. The secondary purpose was to observe the postoperative follow-up treatment pattern and its subgroups (based on different EGFR mutation status and different clinical stages).
Detailed description
About 2,000 eNSCLC patients who received radical resection from about 50 research centers across the country will be included in this study, and will be followed up to 2 years after enrollment according to the actual clinical situation. The analysis method of this study is mainly based on descriptive statistics. The information about the human genetic resources of the subjects to be collected includes: demography, physical examination, WHO fitness status, medical history, smoking history, disease characteristics, surgical information, initial and follow-up adjuvant treatment pattern, laboratory tests, survival status, and adverse events related to gefitinib/osimertinib, serious adverse events/non-severe ADR, measures taken for adverse events, outcome of adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Continuously enroll all patients with early-stage (stage I-III), histopathologically confirmed, and EGFR mutation-positive NSCLC after R0 resection
Key inclusion criteria (4 listed)
- Informed consent signed;
- Newly confirmed EGFR Mutation-Positive NSCLC confirmed by histopathology except for cytology;
- Receiving or not receiving neoadjuvant treatment before surgery;
- Patients with stage I-III NSCLC undergo confirmed radical R0 resection;
Key exclusion criteria (5 listed)
- Patients who currently or have previously participated in any other anti-tumor clinical studies;
- Patients with NSCLC who have received any systemic anti-cancer therapy as the main treatment in the past. Cytotoxic therapy, targeted therapy (tyrosine kinase inhibitors or monoclonal antibodies) and immunotherapy included except for the use of neoadjuvant therapy;
- Patients who have received adjuvant therapy before enrollment.
- Patients with stage I-III NSCLC whose surgical resection cannot be confirmed.
- Patients assessed by the investigator as unfit for enrollment, such as neurological disorders or metabolic disorders, physical examination or laboratory examination suspected that the patient has a possible disease, or has contraindications to the use of study drugs, or has treatment-related complications High risk etc.
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 |
|---|---|---|
| SurgeriesSurgeries | Procedure or surgery | – |
Primary outcome
The distribution of participants with initial adjuvant treatment pattern after radical resection surgery for early-stage NSCLC patients
Time frame: 2 years
Descriptive summary statistics ( total number of cases, number of missing cases, frequency, and percentage of each category) were used to describe the distribution of participants with initial adjuvant treatment patterns, including chemical, targeted, combined, or other therapy. Set subgroup analysis for different initial adjuvant treatment pattern, including different clinical stages (according to phase I/ Phase II/ stage III) and different EGFR mutation status (19del or 21 L858R);
Time on initial adjuvant treatment
Time frame: 2 years
Calculate the time from the start date to the end of initial adjuvant treatment. The total number of cases, number of missing cases, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum were used for statistical description.
The interval from the date of operation to the start date of initial adjuvant therapy with EGFR-TKI.
Time frame: 2 years
Calculate the interval of operation to the adjuvant therapy with EGFR-TKI, which is classified into single-drug therapy and combined therapy. The total number of cases, number of missing cases, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum were used for statistical description.
Numbers of therapy cycles of initial adjuvant treatment
Time frame: 2 years
The patients with chemotherapy were mainly calculated, divided into chemotherapy and targeted combination chemotherapy. The total number of chemotherapy cycles, the number of missing cases, the mean, standard deviation, the median, the 25th and 75th percentiles, the minimum and the maximum were statistically described
4 secondary outcomes
The distribution of participants with follow-up treatment pattern after initial adjuvant treatment.
Time frame: 2 years
Time on follow-up treatment
Time frame: 2 years
The interval from the date of operation to the start date of the follow-up treatment with EGFR-TKI.
Time frame: 2 years
Numbers of therapy cycles of follow-up treatment
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- 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. This study is not recruiting at the moment.
jianxing He, President principal investigator
The First Affiliated Hospital of Guangzhou Medical University
51 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, Stage I and NSCLC, Stage II, run by The First Affiliated Hospital of Guangzhou Medical University at 51 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The distribution of participants with initial adjuvant treatment pattern after radical resection surgery for early-stage NSCLC patients (time frame: 2 years). The study lists 4 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 30 Jul 2025.