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

NCT ID: NCT05513664

Last Updated: 2022-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-30

Study Completion Date

2023-08-31

Brief Summary

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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

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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).

Conditions

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Locally Advanced or Metastatic Non-Small Cell Lung Cancer EGFR Exon20 Insertion Mutations

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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Osimertinib

80 or 160 mg/qd

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Shanghai JMT-Bio Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Affiliated Hospital of Hebei University

Baoding, , China

Site Status

Beijing Cancer Hospital

Beijing, , China

Site Status

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, , China

Site Status

Chinese People's Liberation Army General Hospital

Beijing, , China

Site Status

Chongqing Cancer Hospital

Chongqing, , China

Site Status

Southwest Hospital of Army Medical University

Chongqing, , China

Site Status

Fujian Cancer Hospital

Fuzhou, , China

Site Status

Sun Yat-sen University Cancer Center

Guangzhou, , China

Site Status

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, , China

Site Status

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, , China

Site Status

Anhui Cancer Hospital

Hefei, , China

Site Status

Shandong Cancer Hospital

Jinan, , China

Site Status

Nanjing Chest Hospital

Nanjing, , China

Site Status

Fudan University Cancer Hospital

Shanghai, , China

Site Status

Shanghai Chest Hospital

Shanghai, , China

Site Status

Shanxi Provincial People's Hospital

Shanxi, , China

Site Status

The Fourth Hospital of Hebei Medical University

Shijia Zhuang, , China

Site Status

West China Hospital of Sichuan University

Sichuan, , China

Site Status

Shanxi Cancer Hospital

Taiyuan, , China

Site Status

Huazhong University of Science Tongji Hospital, Tongji Medical College

Wuhan, , China

Site Status

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, , China

Site Status

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, , China

Site Status

First Affiliated Hospital of Zhengzhou University

Zhengzhou, , China

Site Status

Henan Cancer Hospital

Zhengzhou, , China

Site Status

Countries

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China

Central Contacts

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Lei Li

Role: CONTACT

13711344347

Facility Contacts

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Aimin Zang

Role: primary

Jian Fang

Role: primary

Yan Wang

Role: primary

Yi Hu

Role: primary

Xia Chen

Role: primary

Xiangdong Zhou

Role: primary

Wu Zhuang

Role: primary

Li Zhang

Role: primary

Chengzhi Zhou

Role: primary

Yubiao Guo

Role: primary

Hu Liu

Role: primary

Xiaoyong Tang

Role: primary

Yong Lin

Role: primary

Zhihuang Hu

Role: primary

Wei Zhang

Role: primary

Shuili Wang

Role: primary

Da Jiang

Role: primary

Feng Luo

Role: primary

Wei Guo

Role: primary

Qian Chu

Role: primary

Xiaorong Dong

Role: primary

Yu Yao

Role: primary

Xingya Li

Role: primary

Huijuan Wang

Role: primary

Other Identifiers

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JMT101-010

Identifier Type: -

Identifier Source: org_study_id

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