Clinical trial NCT04830826: A Real-world Study of Adjuvant Therapy in Early Stage NSCLC With EGFR Mutation-Positive in China
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NSCLC, Stage I
NSCLC, Stage II
NSCLC, Stage III
Keywords: EGFR Mutation
NSCLC
Adjuvant Therapy
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Continuously enroll all patients with early-stage (stage I-III), histopathologically confirmed, and EGFR mutation-positive NSCLC after R0 resection

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The distribution of participants with initial adjuvant treatment pattern after radical resection surgery for early-stage NSCLC patients
timeFrame: 2 years
measure: Time on initial adjuvant treatment
timeFrame: 2 years
measure: The interval from the date of operation to the start date of initial adjuvant therapy with EGFR-TKI.
timeFrame: 2 years
measure: Numbers of therapy cycles of initial adjuvant treatment
timeFrame: 2 years
Secondary outcomes:
measure: The distribution of participants with follow-up treatment pattern after initial adjuvant treatment.
timeFrame: 2 years
measure: Time on follow-up treatment
timeFrame: 2 years
measure: The interval from the date of operation to the start date of the follow-up treatment with EGFR-TKI.
timeFrame: 2 years
measure: Numbers of therapy cycles of follow-up treatment
timeFrame: 2 years
Other outcomes:
Locations:
city: Peking
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Peking
country: China
facility: Beijing Chest Hospital，Capital Medical university
state: Beijing
city: Peking
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Peking
country: China
facility: Peking University People'S Hospital
state: Beijing
city: Peking
country: China
facility: Peking University Third Hospital
state: Beijing
city: Peking
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Guangzhou
country: China
facility: Cancer Center of Guangzhou Medical university
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital,Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Zhanjiang
country: China
facility: Affiliated Hospital of Guangdong Medical University
state: Guangdong
city: Nanning
country: China
facility: The second affiliated hospital of guangxi medical university
state: Guangxi
city: Cangzhou
country: China
facility: Cangzhou Central Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Anyang
country: China
facility: Anyang Tumour Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital Of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: Bethune first hospital of jilin university
state: Jilin
city: Changchun
country: China
facility: China-Japan Union Hospital of JiLin University
state: Jilin
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Chifeng
country: China
facility: Affiliated Hospital of Chifeng University
state: Neimenggu
city: Hohhot
country: China
facility: The Affliated of Inner Mongolia Medical University
state: Neimenggu
city: Jinan
country: China
facility: Qilu Hospital of Shandong Yniversity
state: Shandong
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Zibo
country: China
facility: PKUCare Luzhong Hospital
state: Shangdong
city: Shanghai
country: China
facility: Shanghai Jiaotong University Medical College Affiliated Ruijin hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: ZhongShan Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuang
city: Luzhou
country: China
facility: The Affliated of Southwest Medical University
state: Sichuang
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Sir Run Shaw Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The first affiliated hospital zhejiang university
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated hospital of Zhejiang University Achool of Medical
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang cancer hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Medical Center Lihuili Hospital
state: Zhejiang
city: Shaoxing
country: China
facility: Shaoxing People's Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospita of Zhejiang Province
state: Zhejiang
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: jianxing He, President
role: PRINCIPAL_INVESTIGATOR
References: