Real-World Effectiveness of Osimertinib for Patients With Non-Small Cell Lung Cancer
To Evaluate Real-World Effectiveness of Osimertinib for Patients With Advanced or Metastatic Epidermal Growth Factor Receptor 20exon Insertion Mutation (20ins) Non-Small Cell Lung Cancer (NSCLC)
1 other identifier
observational
80
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2022
Shorter than P25 for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2022
CompletedFirst Posted
Study publicly available on registry
August 24, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedAugust 24, 2022
July 1, 2022
9 months
August 23, 2022
August 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
1.Real world Objective Response Rate (rwORR)
March 2017 to May 2022
Secondary Outcomes (3)
Real world Duration of Response（rwDOR）
From March 2017 to May 2022
Real world Disease Control Rate（rwDCR）
From March 2017 to May 2022
Real world Progression Free Survival（rwPFS）
From March 2017 to May 2022
Interventions
80 or 160 mg/qd
Eligibility Criteria
Patients who have received osimertinib with advanced or metastatic EGFR 20exon insertion mutation (20ins) Non-Small Cell Lung Cancer.
You may qualify if:
- 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.).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Affiliated Hospital of Hebei University
Baoding, China
Beijing Cancer Hospital
Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Chinese People's Liberation Army General Hospital
Beijing, China
Chongqing Cancer Hospital
Chongqing, China
Southwest Hospital of Army Medical University
Chongqing, China
Fujian Cancer Hospital
Fuzhou, China
Sun Yat-sen University Cancer Center
Guangzhou, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, China
Anhui Cancer Hospital
Hefei, China
Shandong Cancer Hospital
Jinan, China
Nanjing Chest Hospital
Nanjing, China
Fudan University Cancer Hospital
Shanghai, China
Shanghai Chest Hospital
Shanghai, China
Shanxi Provincial People's Hospital
Shanxi, China
The Fourth Hospital of Hebei Medical University
Shijia Zhuang, China
West China Hospital of Sichuan University
Sichuan, China
Shanxi Cancer Hospital
Taiyuan, China
Huazhong University of Science Tongji Hospital, Tongji Medical College
Wuhan, 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
First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Henan Cancer Hospital
Zhengzhou, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2022
First Posted
August 24, 2022
Study Start
September 1, 2022
Primary Completion
June 1, 2023
Study Completion
August 1, 2023
Last Updated
August 24, 2022
Record last verified: 2022-07