Real-World Effectiveness of Osimertinib for Patients With Non-Small Cell Lung Cancer
- Conditions
- EGFR Exon20 Insertion MutationsLocally Advanced or Metastatic Non-Small Cell Lung Cancer
- Registration Number
- NCT05513664
- Lead Sponsor
- Shanghai JMT-Bio Inc.
- Brief 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- Locally advanced or metastatic (stage ШB-Ⅳ, 8th AJCC) NSCLC confirmed by histology or cytology;
- The result of EGFR 20ins is positive detected by tissue, blood, pleural fluid or cerebrospinal fluid;
- Have received osimertinib treatment after detection of EGFR 20ins;
- Age of 18 years or above;
- 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.).
- Previously treated with JMT101 (Patients will be included if osimertinib treatment is before JMT101 treatment);
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Real world Objective Response Rate (rwORR) March 2017 to May 2022
- Secondary Outcome Measures
Name Time Method Real world Duration of Response（rwDOR） From March 2017 to May 2022 Real world Progression Free Survival（rwPFS） From March 2017 to May 2022 Real world Disease Control Rate（rwDCR） From March 2017 to May 2022
Trial Locations
- Locations (24)
Shanghai Chest Hospital
🇨🇳Shanghai, China
Chongqing Cancer Hospital
🇨🇳Chongqing, China
Southwest Hospital of Army Medical University
🇨🇳Chongqing, China
Chinese People's Liberation Army General Hospital
🇨🇳Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, China
Shanxi Provincial People's Hospital
🇨🇳Shanxi, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijia Zhuang, China
Affiliated Hospital of Hebei University
🇨🇳Baoding, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, China
Nanjing Chest Hospital
🇨🇳Nanjing, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, China
Anhui Cancer Hospital
🇨🇳Hefei, China
Fudan University Cancer Hospital
🇨🇳Shanghai, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, China
The First Affiliated Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, China
Shandong Cancer Hospital
🇨🇳Jinan, China
Shanxi Cancer Hospital
🇨🇳Taiyuan, China
West China Hospital of Sichuan University
🇨🇳Sichuan, China
Huazhong University of Science Tongji Hospital, Tongji Medical College
🇨🇳Wuhan, China
First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, China
Henan Cancer Hospital
🇨🇳Zhengzhou, China
Fujian Cancer Hospital
🇨🇳Fuzhou, China