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

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).

Study Overview

• Status: Completed
• Conditions: NSCLC, Stage III; NSCLC, Stage I; NSCLC, Stage II
• Intervention / Treatment: Procedure: Surgeries

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 Type: Observational
• Enrollment (Actual): 1490

Contacts and Locations

Study Locations

• China
  • Beijing
    • Peking, Beijing, China, 100000
      • Peking University Third Hospital
    • Peking, Beijing, China, 100000
      • Beijing Cancer Hospital
    • Peking, Beijing, China, 100000
      • Beijing Chest Hospital,Capital Medical University
    • Peking, Beijing, China, 100000
      • Peking Union Medical College Hospital
    • Peking, Beijing, China, 100000
      • Peking University People's Hospital
    • Peking, Beijing, China, 100000
      • Xuanwu Hospital Capital Medical University
  • Chongqing
    • Chongqing, Chongqing, China, 400000
      • Chongqing Cancer Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • Fujian Provincial Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • The First Affiliated Hospital,Sun Yat-Sen University
    • Guangzhou, Guangdong, China, 510000
      • The First Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China, 510000
      • Guangdong Provincial People's Hospital
    • Guangzhou, Guangdong, China, 510000
      • Cancer Center of Guangzhou Medical University
    • Shenzhen, Guangdong, China, 518000
      • ShenZhen People's Hospital
    • Zhanjiang, Guangdong, China, 524000
      • Affiliated Hospital of Guangdong Medical University
  • Guangxi
    • Nanning, Guangxi, China, 530000
      • The Second Affiliated Hospital of Guangxi Medical University
  • Hebei
    • Cangzhou, Hebei, China, 061000
      • Cangzhou Central Hospital
    • Shijiazhuang, Hebei, China, 50000
      • The Fourth Hospital of Hebei Medical University
  • Henan
    • Anyang, Henan, China, 455000
      • Anyang Tumour Hospital
    • Zhengzhou, Henan, China, 450000
      • Henan Provincial People's Hospital
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410000
      • Xiangya Hospital Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Jiangsu Province Hospital
    • Suzhou, Jiangsu, China, 215000
      • the First Affiliated Hospital of Soochow University
    • Suzhou, Jiangsu, China, 215000
      • Suzhou Municipal Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • The Second Affiliated Hospital of Nanchang University
    • Nanchang, Jiangxi, China, 330000
      • The First Affiliated Hospital of Nanchang University
  • Jilin
    • Changchun, Jilin, China, 130000
      • China-Japan Union Hospital of Jilin University
    • Changchun, Jilin, China, 130000
      • Bethune First Hospital Of Jilin University
  • Liaoning
    • Dalian, Liaoning, China, 116000
      • The Second Hospital of Dalian Medical University
    • Shenyang, Liaoning, China, 110000
      • Shengjing Hospital of China Medical University
    • Shenyang, Liaoning, China, 110000
      • The First Hospital of China Medical University
  • Neimenggu
    • Chifeng, Neimenggu, China, 24000
      • Affiliated Hospital of Chifeng University
    • Hohhot, Neimenggu, China, 010000
      • The Affliated of Inner Mongolia Medical University
  • Shandong
    • Jinan, Shandong, China, 250000
      • Shandong Cancer Hospital
    • Jinan, Shandong, China, 250000
      • Qilu Hospital of Shandong Yniversity
  • Shangdong
    • Zibo, Shangdong, China, 255000
      • PKUcare Luzhong Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Zhongshan Hospital
    • Shanghai, Shanghai, China, 200000
      • Shanghai Jiaotong University Medical College Affiliated Ruijin hospital
    • Shanghai, Shanghai, China, 200000
      • Shanghai Jiaotong University School of Medicine
  • Shanxi
    • Taiyuan, Shanxi, China, 030000
      • Shanxi Provincial Cancer Hospital
  • Sichuang
    • Chengdu, Sichuang, China, 610000
      • West China Hospital of Sichuan University
    • Luzhou, Sichuang, China, 646000
      • The Affliated of Southwest Medical University
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • Tianjin Chest Hospital
    • Tianjin, Tianjin, China, 300000
      • Tianjin Medical University General Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310000
      • The First Affiliated Hospital Zhejiang University
    • Hangzhou, Zhejiang, China, 310000
      • Sir Run Shaw Hospital Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310000
      • The Second Affiliated hospital of Zhejiang University Achool of Medical
    • Ningbo, Zhejiang, China, 315000
      • Ningbo Medical Center Lihuili Hospital
    • Shaoxing, Zhejiang, China, 312000
      • Shaoxing People's Hospital
    • Taizhou, Zhejiang, China, 318000
      • Taizhou Hospita of Zhejiang Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Investigators: Principal Investigator: jianxing He, President, The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2020
• Primary Completion (Actual): July 8, 2024
• Study Completion (Actual): April 7, 2025

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: NSCLC; Adjuvant Therapy; EGFR Mutation
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: D7913C00727

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No