NCT05513664

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

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)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Shanghai JMT-Bio Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

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

Interventions

Type	Name	Description
DRUG	Osimertinib	80 or 160 mg/qd

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-06-01
• Completion: 2023-08-01
• First posted: 2022-08-24
• Last updated: 2022-08-24

Locations

24 sites across 1 country: China