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Recruiting Phase 2 NCT06517953

Befotertinib and Icotinib for NSCLC With Uncommon EGFR Mutations

Trial Parameters

Condition Non-small Cell Lung Cancer Metastatic
Sponsor Sun Yat-sen University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 23
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-07-17
Completion 2026-07-30
Interventions
IcotinibBefotertinib

Brief Summary

This research study aims to explore the combination of two targeted drugs as first-line treatment for Non-Small Cell Lung Cancer (NSCLC) with uncommon EGFR mutation.

Eligibility Criteria

Inclusion Criteria: 1. 18 years of age or older. 2. Pathologically confirmed adenocarcinoma of the lung, with locally advanced or metastatic disease and not amenable to curative surgery or radiotherapy (stage IIIB, IIIC or IV disease based on the eighth edition of the American Joint Committee on Cancer (AJCC) TNM classification). Patients with mixed histology are eligible if adenocarcinoma is the predominant histology. 3. Patients must be treatment-naive for locally advanced or metastatic NSCLC systemic antitumor therapy. Prior adjuvant and neo-adjuvant therapy (except for EGFR-TKIs) is permitted if have been completed at least 6 months prior to initiation of disease progression. 4. Tissue or blood samples are confirmed by the central laboratory or research center as rare EGFR mutations, including exon 18 G719X, S768I in exon 20 and at least one of the L861Q mutations in exon 21; 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 6. Predicted survival ≥ 3 months

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