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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai JMT-Bio Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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