Locally Advanced or Metastatic Non-Small Cell Lung CancerNCT05513664
Real-World Effectiveness of Osimertinib for Patients With Non-Small Cell Lung Cancer
An observational study of Locally Advanced or Metastatic Non-Small Cell Lung Cancer and EGFR Exon20 Insertion Mutations, run by Shanghai JMT-Bio Inc. at 24 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Non-Small Cell Lung Cancer, EGFR Exon20 Insertion Mutations
- What is being tested?
- Osimertinib
- How many people
- 80 participants
- Where
- 24 sitesChina
- Study dates
- Sep 2022to Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have received osimertinib with advanced or metastatic EGFR 20exon insertion mutation (20ins) Non-Small Cell Lung Cancer.
Who may be able to join
- 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.).
Who cannot join
- 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.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
China24 sites
Affiliated Hospital of Hebei University
Baoding
Aimin Zang
Beijing Cancer Hospital
Beijing
Jian Fang
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Yan Wang
Chinese People's Liberation Army General Hospital
Beijing
Yi Hu
Chongqing Cancer Hospital
Chongqing
Xia Chen
Southwest Hospital of Army Medical University
Chongqing
Xiangdong Zhou
Fujian Cancer Hospital
Fuzhou
Wu Zhuang
Sun Yat-sen University Cancer Center
Guangzhou
Li Zhang, zhangli@sysucc.org.cn
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
Chengzhi Zhou
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou
Yubiao Guo
Anhui Cancer Hospital
Hefei
Hu Liu
Shandong Cancer Hospital
Jinan
Xiaoyong Tang
Nanjing Chest Hospital
Nanjing
Yong Lin
Fudan University Cancer Hospital
Shanghai
Zhihuang Hu
Shanghai Chest Hospital
Shanghai
Wei Zhang
Shanxi Provincial People's Hospital
Shanxi
Shuili Wang
The Fourth Hospital of Hebei Medical University
Shijia Zhuang
Da Jiang
West China Hospital of Sichuan University
Sichuan
Feng Luo
Shanxi Cancer Hospital
Taiyuan
Wei Guo
Huazhong University of Science Tongji Hospital, Tongji Medical College
Wuhan
Qian Chu
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Xiaorong Dong
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Yu Yao
First Affiliated Hospital of Zhengzhou University
Zhengzhou
Xingya Li
Henan Cancer Hospital
Zhengzhou
Huijuan Wang
About this study
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)
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.
Read the 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).
- Conditions
- Locally Advanced or Metastatic Non-Small Cell Lung Cancer, EGFR Exon20 Insertion Mutations
- Being tested
- Osimertinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsimertinibDrug
80 or 160 mg/qd
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Real world Objective Response Rate (rwORR)
Measured: March 2017 to May 2022
Secondary outcomes (3)
Real world Duration of Response（rwDOR）
Measured: From March 2017 to May 2022
Real world Disease Control Rate（rwDCR）
Measured: From March 2017 to May 2022
Real world Progression Free Survival（rwPFS）
Measured: From March 2017 to May 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study startSep 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai JMT-Bio Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513664
- Sponsor's protocol ID
- JMT101-010
- Status last verified
- Jul 2022
- First submitted
- 23 Aug 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05513664
- Acronym / sponsor ID
- JMT101-010
- Conditions
- Locally Advanced or Metastatic Non-Small Cell Lung Cancer, EGFR Exon20 Insertion Mutations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
- Collaborators
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Study start
- Sep 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have received osimertinib with advanced or metastatic EGFR 20exon insertion mutation (20ins) Non-Small Cell Lung Cancer.
Key inclusion criteria (5 listed)
- 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.).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osimertinib80 or 160 mg/qd | Drug | – |
Primary outcome
1.Real world Objective Response Rate (rwORR)
Time frame: March 2017 to May 2022
3 secondary outcomes
Real world Duration of Response（rwDOR）
Time frame: From March 2017 to May 2022
Real world Disease Control Rate（rwDCR）
Time frame: From March 2017 to May 2022
Real world Progression Free Survival（rwPFS）
Time frame: From March 2017 to May 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced or Metastatic Non-Small Cell Lung Cancer and EGFR Exon20 Insertion Mutations, run by Shanghai JMT-Bio Inc. at 24 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Li (13711344347, lclilei@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.Real world Objective Response Rate (rwORR) (time frame: March 2017 to May 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.