Trial Title:
Real-World Effectiveness of Osimertinib for Patients With Non-Small Cell Lung Cancer
NCT ID:
NCT05513664
Condition:
Locally Advanced or Metastatic Non-Small Cell Lung Cancer
EGFR Exon20 Insertion Mutations
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Osimertinib
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Drug
Intervention name:
Osimertinib
Description:
80 or 160 mg/qd
Summary:
This study is a retrospective real-world study to evaluate the efficacy of Osimertinib
for patients with advanced or metastatic EGFR 20exon insertion mutation (20ins) Non-Small
Cell Lung Cancer.
Detailed description:
This is a multicenter, retrospective observational real-world study, which evaluates the
efficacy of Osimertinib, between 2017 and 2022, in patients with advanced or metastatic
EGFR 20exon insertion mutation (20ins) Non-Small Cell Lung Cancer. This study serves as
the external control for a single arm phase II trial on JMT101 combined with Osimertinib
in patients with Non-Small Cell Lung Cancer. The primary outcome measure is objective
response rate (ORR).
Criteria for eligibility:
Study pop:
Patients who have received osimertinib with advanced or metastatic EGFR 20exon insertion
mutation (20ins) Non-Small Cell Lung Cancer.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Locally advanced or metastatic (stage ШB-Ⅳ, 8th AJCC) NSCLC confirmed by histology
or cytology;
2. The result of EGFR 20ins is positive detected by tissue, blood, pleural fluid or
cerebrospinal fluid;
3. Have received osimertinib treatment after detection of EGFR 20ins;
4. Age of 18 years or above;
5. Information about tumor outcome evaluation is required at least once after
osimertinib treatment (such as tumor imaging data, description of efficacy
evaluation in medical records, etc.).
Exclusion Criteria:
1. Previously treated with JMT101 (Patients will be included if osimertinib treatment
is before JMT101 treatment);
2. Patients harboring EGFR exon20 insertion mutation and also have other EGFR
TKI-sensitizing EGFR mutations, such as G719X mutation in exon 18, exon 19 deletion
mutation (19 del), exon 20 T790M or S768I mutation, exon 21 L858R mutation, or L861Q
mutation.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Affiliated Hospital of Hebei University
Address:
City:
Baoding
Country:
China
Contact:
Last name:
Aimin Zang
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Contact:
Last name:
Jian Fang
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Country:
China
Contact:
Last name:
Yan Wang
Facility:
Name:
Chinese People's Liberation Army General Hospital
Address:
City:
Beijing
Country:
China
Contact:
Last name:
Yi Hu
Facility:
Name:
Chongqing Cancer Hospital
Address:
City:
Chongqing
Country:
China
Contact:
Last name:
Xia Chen
Facility:
Name:
Southwest Hospital of Army Medical University
Address:
City:
Chongqing
Country:
China
Contact:
Last name:
Xiangdong Zhou
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Contact:
Last name:
Wu Zhuang
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Contact:
Last name:
Li Zhang
Email:
zhangli@sysucc.org.cn
Facility:
Name:
The First Affiliated Hospital of Guangzhou Medical University
Address:
City:
Guangzhou
Country:
China
Contact:
Last name:
Chengzhi Zhou
Facility:
Name:
The First Affiliated Hospital of Sun Yat-Sen University
Address:
City:
Guangzhou
Country:
China
Contact:
Last name:
Yubiao Guo
Facility:
Name:
Anhui Cancer Hospital
Address:
City:
Hefei
Country:
China
Contact:
Last name:
Hu Liu
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Country:
China
Contact:
Last name:
Xiaoyong Tang
Facility:
Name:
Nanjing Chest Hospital
Address:
City:
Nanjing
Country:
China
Contact:
Last name:
Yong Lin
Facility:
Name:
Fudan University Cancer Hospital
Address:
City:
Shanghai
Country:
China
Contact:
Last name:
Zhihuang Hu
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Country:
China
Contact:
Last name:
Wei Zhang
Facility:
Name:
Shanxi Provincial People's Hospital
Address:
City:
Shanxi
Country:
China
Contact:
Last name:
Shuili Wang
Facility:
Name:
The Fourth Hospital of Hebei Medical University
Address:
City:
Shijia Zhuang
Country:
China
Contact:
Last name:
Da Jiang
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Sichuan
Country:
China
Contact:
Last name:
Feng Luo
Facility:
Name:
Shanxi Cancer Hospital
Address:
City:
Taiyuan
Country:
China
Contact:
Last name:
Wei Guo
Facility:
Name:
Huazhong University of Science Tongji Hospital, Tongji Medical College
Address:
City:
Wuhan
Country:
China
Contact:
Last name:
Qian Chu
Facility:
Name:
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Contact:
Last name:
Xiaorong Dong
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Country:
China
Contact:
Last name:
Yu Yao
Facility:
Name:
First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Country:
China
Contact:
Last name:
Xingya Li
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Contact:
Last name:
Huijuan Wang
Start date:
September 2022
Completion date:
August 2023
Lead sponsor:
Agency:
Shanghai JMT-Bio Inc.
Agency class:
Industry
Collaborator:
Agency:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Agency class:
Industry
Source:
Shanghai JMT-Bio Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05513664
