Real-World Effectiveness of Osimertinib for Patients With Non-Small Cell Lung Cancer

Locally Advanced or Metastatic Non-Small Cell Lung Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05513664
• Other study ID #: JMT101-010
• Status: Not yet recruiting
• Start date: September 2022
• Est. completion date: August 2023

Study information

• Verified date: July 2022
• Source: Shanghai JMT-Bio Inc.
• Contact: Lei Li
• Phone: 13711344347
• Email: lclilei[@]mail.ecspc.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Locally advanced or metastatic (stage ?B-?, 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Locally Advanced or Metastatic Non-Small Cell Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Osimertinib
80 or 160 mg/qd

Locations

Country	Name	City	State
China	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

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai JMT-Bio Inc.	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1.Real world Objective Response Rate (rwORR)		March 2017 to May 2022
Secondary	Real world Duration of Response(rwDOR)		From March 2017 to May 2022
Secondary	Real world Disease Control Rate(rwDCR)		From March 2017 to May 2022
Secondary	Real world Progression Free Survival(rwPFS)		From March 2017 to May 2022