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

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

• Registration Number: NCT05513664
• Lead Sponsor: Shanghai JMT-Bio Inc.

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).

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-23
• Last Update Submitted: 2022-08-23
• Study First Posted: 2022-08-24
• Last Update Posted: 2022-08-24
• Study Start: 2022-09
• Primary Completion: 2023-06
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Real world Objective Response Rate (rwORR)	March 2017 to May 2022

Secondary Outcome Measures

Name	Time	Method
Real world Duration of Response（rwDOR）	From March 2017 to May 2022
Real world Progression Free Survival（rwPFS）	From March 2017 to May 2022
Real world Disease Control Rate（rwDCR）	From March 2017 to May 2022

Trial Locations

Locations (24)

Affiliated Hospital of Hebei University; 🇨🇳 Baoding, China

Beijing Cancer Hospital; 🇨🇳 Beijing, China

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China

Chinese People's Liberation Army General Hospital; 🇨🇳 Beijing, China

Chongqing Cancer Hospital; 🇨🇳 Chongqing, China

Southwest Hospital of Army Medical University; 🇨🇳 Chongqing, China

Fujian Cancer Hospital; 🇨🇳 Fuzhou, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, China

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, China

The First Affiliated Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, China

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