A Real-world Study of Adjuvant Therapy in Early Stage NSCLC With EGFR Mutation-Positive in China

NSCLC, Stage III Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04830826
• Other study ID #: D7913C00727
• Status: Recruiting
• Start date: June 10, 2020
• Est. completion date: July 2024

Study information

• Verified date: March 2021
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: jianxing He, President
• Phone: 13802777270
• Email: hejx[@]vip.163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: July 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Informed consent signed;

2. Newly confirmed EGFR Mutation-Positive NSCLC confirmed by histopathology except for cytology;

3. Receiving or not receiving neoadjuvant treatment before surgery;

4. Patients with stage I-III NSCLC undergo confirmed radical R0 resection;

Exclusion Criteria:

1. Patients who currently or have previously participated in any other anti-tumor clinical studies;

2. 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;

3. Patients who have received adjuvant therapy before enrollment.

4. Patients with stage I-III NSCLC whose surgical resection cannot be confirmed.

5. 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC, Stage I
• NSCLC, Stage II
• NSCLC, Stage III

Intervention

Procedure:
• Surgeries
Surgeries

Locations

Country	Name	City	State
China	Anyang Tumour Hospital	Anyang	Henan
China	Cangzhou Central Hospital	Cangzhou	Hebei
China	Bethune first hospital of jilin university	Changchun	Jilin
China	China-Japan Union Hospital of JiLin University	Changchun	Jilin
China	Xiangya Hospital Central South University	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuang
China	Affiliated Hospital of Chifeng University	Chifeng	Neimenggu
China	Chongqing Cancer Hospital	Chongqing	Chongqing
China	The Second Hospital of Dalian Medical University	Dalian	Liaoning
China	Fujian Provincial Hospital	Fuzhou	Fujian
China	Cancer Center of Guangzhou Medical university	Guangzhou	Guangdong
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital,Sun Yat-sen University	Guangzhou	Guangdong
China	Sir Run Shaw Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The first affiliated hospital zhejiang university	Hangzhou	Zhejiang
China	The Second Affiliated hospital of Zhejiang University Achool of Medical	Hangzhou	Zhejiang
China	Zhejiang cancer hospital	Hangzhou	Zhejiang
China	The Affliated of Inner Mongolia Medical University	Hohhot	Neimenggu
China	Qilu Hospital of Shandong Yniversity	Jinan	Shandong
China	Shandong Cancer Hospital	Jinan	Shandong
China	The Affliated of Southwest Medical University	Luzhou	Sichuang
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The Second Affiliated Hospital Of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	The second affiliated hospital of guangxi medical university	Nanning	Guangxi
China	Ningbo Medical Center Lihuili Hospital	Ningbo	Zhejiang
China	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	Xuanwu Hospital Capital Medical University	Peking	Beijing
China	Shanghai Jiaotong University Medical College Affiliated Ruijin hospital	Shanghai	Shanghai
China	Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	ZhongShan Hospital	Shanghai	Shanghai
China	Shaoxing People's Hospital	Shaoxing	Zhejiang
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Suzhou Municipal Hospital	Suzhou	Jiangsu
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Shanxi Provincial Cancer Hospital	Taiyuan	Shanxi
China	Taizhou Hospita of Zhejiang Province	Taizhou	Zhejiang
China	Tianjin Chest Hospital	Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
China	Affiliated Hospital of Guangdong Medical University	Zhanjiang	Guangdong
China	Henan Provincial People's Hospital	Zhengzhou	Henan
China	PKUCare Luzhong Hospital	Zibo	Shangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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);	2 years
Primary	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.	2 years
Primary	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.	2 years
Primary	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	2 years
Secondary	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);	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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	2 years