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

March 31, 2021 updated by: Jianxing He, The First Affiliated Hospital of Guangzhou Medical University

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

Recruiting

Conditions

Intervention / Treatment

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 (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: jianxing He, President
  • Phone Number: 13802777270
  • Email: hejx@vip.163.com

Study Contact Backup

  • Name: wenhua Liang, Director
  • Phone Number: 13710249454
  • Email: 550627660@qq.com

Study Locations

  • China
    • Beijing
      • Peking, Beijing, China, 100000
        • Not yet recruiting
        • Beijing Cancer Hospital
        • Contact:
      • Peking, Beijing, China, 100000
        • Not yet recruiting
        • Beijing Chest Hospital,Capital Medical University
        • Contact:
      • Peking, Beijing, China, 100000
        • Not yet recruiting
        • Peking Union Medical College Hospital
        • Contact:
      • Peking, Beijing, China, 100000
        • Not yet recruiting
        • Peking University People's Hospital
        • Contact:
          • Fan Yang
      • Peking, Beijing, China, 100000
        • Not yet recruiting
        • Peking University Third Hospital
        • Contact:
      • Peking, Beijing, China, 100000
        • Not yet recruiting
        • Xuanwu Hospital Capital Medical University
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • Not yet recruiting
        • Chongqing Cancer Hospital
        • Contact:
          • Zhiqiang Wang
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Not yet recruiting
        • Fujian Provincial Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Guangzhou, Guangdong, China, 510000
        • Not yet recruiting
        • Cancer Center of Guangzhou Medical University
        • Contact:
      • Guangzhou, Guangdong, China, 510000
        • Not yet recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
      • Guangzhou, Guangdong, China, 510000
        • Not yet recruiting
        • The First Affiliated Hospital，Sun Yat-sen University
        • Contact:
      • Shenzhen, Guangdong, China, 518000
        • Not yet recruiting
        • ShenZhen People's Hospital
        • Contact:
      • Zhanjiang, Guangdong, China, 524000
        • Not yet recruiting
        • Affiliated Hospital of Guangdong Medical University
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530000
        • Not yet recruiting
        • The Second Affiliated Hospital of Guangxi Medical University
        • Contact:
    • Hebei
      • Cangzhou, Hebei, China, 061000
        • Not yet recruiting
        • Cangzhou Central Hospital
        • Contact:
          • Fanyi Kong
      • Shijiazhuang, Hebei, China, 50000
        • Not yet recruiting
        • The Fourth Hospital of Hebei Medical University
        • Contact:
    • Henan
      • Anyang, Henan, China, 455000
        • Not yet recruiting
        • Anyang Tumour Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450000
        • Not yet recruiting
        • Henan Provincial People's Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Not yet recruiting
        • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
          • Yongde Liao
    • Hunan
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • Xiangya Hospital Central South University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Not yet recruiting
        • Jiangsu Province Hospital
        • Contact:
      • Suzhou, Jiangsu, China, 215000
        • Not yet recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
      • Suzhou, Jiangsu, China, 215000
        • Not yet recruiting
        • Suzhou Municipal Hospital
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • Not yet recruiting
        • The first affiliated Hospital of Nanchang University
        • Contact:
      • Nanchang, Jiangxi, China, 330000
        • Not yet recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130000
        • Not yet recruiting
        • Bethune First Hospital of Jilin University
        • Contact:
      • Changchun, Jilin, China, 130000
        • Not yet recruiting
        • China-Japan Union Hospital of Jilin University
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China, 116000
        • Not yet recruiting
        • The Second Hospital of Dalian Medical University
        • Contact:
          • Changhong Liu
      • Shenyang, Liaoning, China, 110000
        • Not yet recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
      • Shenyang, Liaoning, China, 110000
        • Not yet recruiting
        • The First Hospital of China Medical University
        • Contact:
    • Neimenggu
      • Chifeng, Neimenggu, China, 24000
        • Not yet recruiting
        • Affiliated Hospital of Chifeng University
        • Contact:
      • Hohhot, Neimenggu, China, 010000
        • Not yet recruiting
        • The Affliated of Inner Mongolia Medical University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250000
        • Not yet recruiting
        • Qilu Hospital of Shandong Yniversity
        • Contact:
          • Hui Tian
      • Jinan, Shandong, China, 250000
        • Not yet recruiting
        • Shandong Cancer Hospital
        • Contact:
    • Shangdong
      • Zibo, Shangdong, China, 255000
        • Not yet recruiting
        • PKUCare Luzhong Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Not yet recruiting
        • Shanghai Jiaotong University Medical College Affiliated Ruijin hospital
        • Contact:
      • Shanghai, Shanghai, China, 200000
        • Not yet recruiting
        • Shanghai Jiaotong University School of Medicine
        • Contact:
          • Xiaoqing Zhao
      • Shanghai, Shanghai, China, 200000
        • Not yet recruiting
        • ZhongShan Hospital
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Not yet recruiting
        • Shanxi Provincial Cancer Hospital
        • Contact:
          • Hongguang Zhang
    • Sichuang
      • Chengdu, Sichuang, China, 610000
        • Not yet recruiting
        • West China Hospital of Sichuan University
        • Contact:
      • Luzhou, Sichuang, China, 646000
        • Not yet recruiting
        • The Affliated of Southwest Medical University
        • Contact:
          • Tianyang Dai
    • Tianjin
      • Tianjin, Tianjin, China, 300000
        • Not yet recruiting
        • Tianjin Chest Hospital
        • Contact:
          • Xun Zhang
      • Tianjin, Tianjin, China, 300000
        • Not yet recruiting
        • Tianjin Medical University General Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • Sir Run Shaw Hospital Zhejiang University School of Medicine
        • Contact:
          • Zhengfu He
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • The First Affiliated Hospital Zhejiang University
        • Contact:
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • The Second Affiliated hospital of Zhejiang University Achool of Medical
        • Contact:
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • Zhejiang Cancer Hospital
        • Contact:
      • Ningbo, Zhejiang, China, 315000
        • Not yet recruiting
        • Ningbo medical center lihuili hospital
        • Contact:
      • Shaoxing, Zhejiang, China, 312000
        • Not yet recruiting
        • Shaoxing People's Hospital
        • Contact:
          • Guangmao Yu
      • Taizhou, Zhejiang, China, 318000
        • Not yet recruiting
        • Taizhou Hospita of Zhejiang Province
        • Contact:
          • Baofu Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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);
2 years
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.
2 years
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.
2 years
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The distribution of participants with follow-up treatment pattern after initial adjuvant treatment.
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 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
Time Frame: 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.
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
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
Time Frame: 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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2020

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

July 1, 2024

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)

April 5, 2021

Last Update Submitted That Met QC Criteria

March 31, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D7913C00727

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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