• Effect of Osimertinib in Ethnic Chinese With EGFR and T790M Mutated NSCLC

  NCT03133234

  CompletedObservationalUpdated Nov 20, 2018
• Osimertinib With Chemotherapy as First-line Therapy for EGFR Mutation-positive NSCLC

  NCT06376084

  Active, not recruitingObservationalUpdated Aug 18, 2026
• Efficacy of Osimertinib in Patients With Lung Cancer

  NCT06174857

  Unknown statusObservationalUpdated Dec 18, 2023
• Real-world Analysis of Workup at Disease Progression and Implementation of Osimertinib for EGFR+ NSCLC

  NCT04105153

  CompletedObservationalUpdated Nov 22, 2023
• Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutated NSCLC Patients

  NCT06538038

  RecruitingObservationalUpdated Mar 27, 2026
• Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.

  NCT03219970

  CompletedObservationalUpdated Sep 14, 2021

ClinicalTrials.gov ID

NCT05513664

Lead Sponsor

Shanghai JMT-Bio Inc.INDUSTRY

Overall Status

Unknown status

Study Type

Observational

Enrollment

80Estimated

Last Update Posted

Aug 24, 2022Actual

Start Date

Sep 2022Estimated

Primary Completion Date

Jun 2023Estimated

Completion Date

Aug 2023Estimated

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)

Brief 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.

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).

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

• Osimertinib

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Observational Model

Other

Time Perspective

Retrospective

Lead Sponsor

Shanghai JMT-Bio Inc.INDUSTRY

Collaborators

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.INDUSTRY

zhangli@sysucc.org.cn