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

August 23, 2022 updated by: Shanghai JMT-Bio Inc.

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)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Baoding, China
        • Affiliated Hospital of Hebei University
      • Beijing, China
        • Beijing Cancer Hospital
      • Beijing, China
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
          • Yan Wang
      • Beijing, China
        • Chinese People's Liberation Army General Hospital
      • Chongqing, China
        • Chongqing Cancer Hospital
        • Contact:
          • Xia Chen
      • Chongqing, China
        • Southwest Hospital of Army Medical University
        • Contact:
          • Xiangdong Zhou
      • Fuzhou, China
        • Fujian Cancer Hospital
        • Contact:
          • Wu Zhuang
      • Guangzhou, China
      • Guangzhou, China
        • The First Affiliated Hospital of Sun Yat-sen University
        • Contact:
          • Yubiao Guo
      • Guangzhou, China
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
          • Chengzhi Zhou
      • Hefei, China
        • Anhui Cancer Hospital
        • Contact:
          • Hu Liu
      • Jinan, China
        • Shandong Cancer Hospital
        • Contact:
          • Xiaoyong Tang
      • Nanjing, China
        • Nanjing Chest Hospital
        • Contact:
          • Yong Lin
      • Shanghai, China
        • Shanghai Chest Hospital
      • Shanghai, China
        • Fudan University Cancer Hospital
        • Contact:
          • Zhihuang Hu
      • Shanxi, China
        • Shanxi Provincial People's Hospital
        • Contact:
          • Shuili Wang
      • Shijia Zhuang, China
        • The Fourth Hospital of Hebei Medical University
      • Sichuan, China
        • West China Hospital of Sichuan University
        • Contact:
          • Feng Luo
      • Taiyuan, China
        • Shanxi Cancer Hospital
      • Wuhan, China
        • Huazhong University of Science Tongji Hospital, Tongji Medical College
        • Contact:
          • Qian Chu
      • Wuhan, China
        • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Xiaorong Dong
      • Xi'an, China
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Yu Yao
      • Zhengzhou, China
        • Henan Cancer Hospital
        • Contact:
          • Huijuan Wang
      • Zhengzhou, China
        • First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Xingya Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have received osimertinib with advanced or metastatic EGFR 20exon insertion mutation (20ins) Non-Small Cell Lung Cancer.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
1.Real world Objective Response Rate (rwORR)
Time Frame: March 2017 to May 2022
March 2017 to May 2022

Secondary Outcome Measures

Outcome Measure
Time Frame
Real world Duration of Response（rwDOR）
Time Frame: From March 2017 to May 2022
From March 2017 to May 2022
Real world Disease Control Rate（rwDCR）
Time Frame: From March 2017 to May 2022
From March 2017 to May 2022
Real world Progression Free Survival（rwPFS）
Time Frame: From March 2017 to May 2022
From March 2017 to May 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai JMT-Bio Inc.

Collaborators

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

August 23, 2022

First Submitted That Met QC Criteria

August 23, 2022

First Posted (Actual)

August 24, 2022

Study Record Updates

Last Update Posted (Actual)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JMT101-010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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