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

Launched by SHANGHAI JMT-BIO INC. · Aug 23, 2022

Keywords

ClinConnect Summary

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).

Gender

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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.