A Real-world Study of Adjuvant Therapy in Early Stage NSCLC With EGFR Mutation-Positive in China
- Conditions
- NSCLC, Stage IIINSCLC, Stage INSCLC, Stage II
- Registration Number
- NCT04830826
- Lead Sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Brief 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. 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2000
- 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;
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The distribution of participants with initial adjuvant treatment pattern after radical resection surgery for early-stage NSCLC patients 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);The interval from the date of operation to the start date of initial adjuvant therapy with EGFR-TKI. 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 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
Time on initial adjuvant treatment 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.
- Secondary Outcome Measures
Name Time Method Numbers of therapy cycles of follow-up treatment 2 years 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
The distribution of participants with follow-up treatment pattern after initial adjuvant treatment. 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 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);The interval from the date of operation to the start date of the follow-up treatment with EGFR-TKI. 2 years 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.
Time on follow-up treatment 2 years 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.
Trial Locations
- Locations (51)
Beijing Cancer Hospital
🇨🇳Peking, Beijing, China
Beijing Chest Hospital，Capital Medical university
🇨🇳Peking, Beijing, China
Peking Union Medical College Hospital
🇨🇳Peking, Beijing, China
Peking University People'S Hospital
🇨🇳Peking, Beijing, China
Peking University Third Hospital
🇨🇳Peking, Beijing, China
Chongqing Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Xuanwu Hospital Capital Medical University
🇨🇳Peking, Beijing, China
Cancer Center of Guangzhou Medical university
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital,Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Shenzhen People's Hospital
🇨🇳Shenzhen, Guangdong, China
Cangzhou Central Hospital
🇨🇳Cangzhou, Hebei, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
Suzhou Municipal Hospital
🇨🇳Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The Second Affiliated Hospital Of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Bethune first hospital of jilin university
🇨🇳Changchun, Jilin, China
China-Japan Union Hospital of JiLin University
🇨🇳Changchun, Jilin, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Affiliated Hospital of Chifeng University
🇨🇳Chifeng, Neimenggu, China
Qilu Hospital of Shandong Yniversity
🇨🇳Jinan, Shandong, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
Shanghai Jiaotong University Medical College Affiliated Ruijin hospital
🇨🇳Shanghai, Shanghai, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuang, China
The Affliated of Southwest Medical University
🇨🇳Luzhou, Sichuang, China
Tianjin Chest Hospital
🇨🇳Tianjin, Tianjin, China
The first affiliated hospital zhejiang university
🇨🇳Hangzhou, Zhejiang, China
Sir Run Shaw Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The Second Affiliated hospital of Zhejiang University Achool of Medical
🇨🇳Hangzhou, Zhejiang, China
Zhejiang cancer hospital
🇨🇳Hangzhou, Zhejiang, China
Ningbo Medical Center Lihuili Hospital
🇨🇳Ningbo, Zhejiang, China
Taizhou Hospita of Zhejiang Province
🇨🇳Taizhou, Zhejiang, China
Fujian Provincial Hospital
🇨🇳Fuzhou, Fujian, China
Affiliated Hospital of Guangdong Medical University
🇨🇳Zhanjiang, Guangdong, China
The second affiliated hospital of guangxi medical university
🇨🇳Nanning, Guangxi, China
Anyang Tumour Hospital
🇨🇳Anyang, Henan, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
The Second Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
The Affliated of Inner Mongolia Medical University
🇨🇳Hohhot, Neimenggu, China
PKUCare Luzhong Hospital
🇨🇳Zibo, Shangdong, China
Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Shanxi Provincial Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Shaoxing People's Hospital
🇨🇳Shaoxing, Zhejiang, China
ZhongShan Hospital
🇨🇳Shanghai, Shanghai, China