A protocol of a single arm, prospective, open-label, multicenter, phase II study of ramucirumab and erlotinib in treatment-naïve non-small cell lung cancer patients with EGFR mutation and brain metastases (SPIRAL-BRAIN study)
2023 Translational Lung Cancer Research. All rights reserved..
Background: The combination of erlotinib, a first-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), and ramucirumab, an anti-vascular endothelial growth factor receptor (VEGFR) antibody, is one of the most effective treatments for patients with non-small cell lung cancer (NSCLC) and EGFR mutation. However, little is known about the safety and efficacy of this combination treatment for patients with brain metastases.
Methods: This single arm, prospective, open-label, multicenter, phase II study will recruit 32 NSCLC patients with EGFR mutation (except for T790M mutation) and brain metastases (asymptomatic or mild symptoms). Patients will be treated with erlotinib at a dose of 150 mg/body once daily and ramucirumab at a dose of 10 mg/kg once every 2 weeks. The primary endpoint is intracranial overall response rate (iORR) and the secondary endpoints are intracranial disease control rate, intracranial progression-free survival (iPFS), extracranial ORR, extracranial PFS, ORR, overall PFS, overall survival (OS), and safety. The planned number of enrollments was calculated based on a one-sample binomial test (normal approximation) with a two-sided α level of 5% and 80% power, assuming that the expected iORR is 65% and the iORR threshold is 40%.
Discussion: A prospective study to confirm the safety and efficacy of the combined erlotinib plus ramucirumab treatment for NSCLC patients with EGFR mutation and brain metastases is ongoing.
Trial Registration: Japan Registry of Clinical Trials, jRCTs051220059.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:12 |
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| Enthalten in: |
Translational lung cancer research - 12(2023), 8 vom: 30. Aug., Seite 1802-1806 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Sawada, Ryo [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Revised 13.09.2023 published: Print-Electronic Citation Status PubMed-not-MEDLINE |
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| doi: |
10.21037/tlcr-23-109 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 245 | 1 | 2 | |a A protocol of a single arm, prospective, open-label, multicenter, phase II study of ramucirumab and erlotinib in treatment-naïve non-small cell lung cancer patients with EGFR mutation and brain metastases (SPIRAL-BRAIN study) |
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| 500 | |a Date Revised 13.09.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a 2023 Translational Lung Cancer Research. All rights reserved. | ||
| 520 | |a Background: The combination of erlotinib, a first-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), and ramucirumab, an anti-vascular endothelial growth factor receptor (VEGFR) antibody, is one of the most effective treatments for patients with non-small cell lung cancer (NSCLC) and EGFR mutation. However, little is known about the safety and efficacy of this combination treatment for patients with brain metastases | ||
| 520 | |a Methods: This single arm, prospective, open-label, multicenter, phase II study will recruit 32 NSCLC patients with EGFR mutation (except for T790M mutation) and brain metastases (asymptomatic or mild symptoms). Patients will be treated with erlotinib at a dose of 150 mg/body once daily and ramucirumab at a dose of 10 mg/kg once every 2 weeks. The primary endpoint is intracranial overall response rate (iORR) and the secondary endpoints are intracranial disease control rate, intracranial progression-free survival (iPFS), extracranial ORR, extracranial PFS, ORR, overall PFS, overall survival (OS), and safety. The planned number of enrollments was calculated based on a one-sample binomial test (normal approximation) with a two-sided α level of 5% and 80% power, assuming that the expected iORR is 65% and the iORR threshold is 40% | ||
| 520 | |a Discussion: A prospective study to confirm the safety and efficacy of the combined erlotinib plus ramucirumab treatment for NSCLC patients with EGFR mutation and brain metastases is ongoing | ||
| 520 | |a Trial Registration: Japan Registry of Clinical Trials, jRCTs051220059 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Non-small cell lung cancer (NSCLC) | |
| 650 | 4 | |a brain metastasis | |
| 650 | 4 | |a epidermal growth factor receptor mutation (EGFR mutation) | |
| 650 | 4 | |a epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) | |
| 650 | 4 | |a vascular endothelial growth factor or vascular endothelial growth factor receptor inhibitor (VEGF or VEGFR inhibitor) | |
| 700 | 1 | |a Nishioka, Naoya |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Young Hak |e verfasserin |4 aut | |
| 700 | 1 | |a Kiyomi, Fumiaki |e verfasserin |4 aut | |
| 700 | 1 | |a Uchino, Junji |e verfasserin |4 aut | |
| 700 | 1 | |a Takayama, Koichi |e verfasserin |4 aut | |
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