A Phase 2 interventional study of Osimertinib and Bevacizumab in Leptomeningeal Metastasis, Non-small Cell Lung Cancer and EGFR Activating Mutation, sponsored by Second Affiliated Hospital of Nanchang University. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-11-04.
Sponsored by Second Affiliated Hospital of Nanchang University · Phase 2, Interventional, and Treatment
Leptomeningeal metastasis (LM) is a devastating and terminal complication of advanced non-small-cell lung cancer (NSCLC), especially in patients harboring epidermal growth factor receptor (EGFR) mutations. Osimertinib is an oral,third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that selectively inhibits both EGFR-TKI-sensitizing and EGFR T790M resistance mutations .AURA I/II study and other preclinical study suggested that Osimertinib exhibited a better blood-brain barrier(BBB) penetration than the other EGFR-TKIs (gefitinib, erlotinib, or afatinib).The BLOOM 、AURA and FLURA study demonstrated that osimertinib showed encouraging activity and manageable tolerability in pretreated EGFR-mutant NSCLC patients with LM. Bevacizumab is a monoclonal antibody against vascular endothelial growth factor (VEGF). Animal study and autopsy specimens showed that VEGF is an essential factor in LM. Recently study showed EGFR-TKIs plus bevacizumab prolonged PFS and OS in patients with EGFR-mutant NSCLC and multiple brain mteastasis when compared with EGFR-TKIs alone. Howerver osimertinib combined with bevacizumab could benefit patients with LM from EGFR- mutant NSCLC remains undetermined. Therefore, the purpose of the study is to evaluate the safety and efficacy of osimertinib combined with bevacizumab for EGFR- mutant non-small cell lung cancer with leptomeningeal metastasis
This is a randomized phase II clinical trial. The objective of the study is to assess the efficacy of osimertinib combined with bevacizumab for LM from EGFR- mutant NSCLC. Patients were randomized with equal allocation to 80 mg of oral Osimertinib daily alone or with 7.5 mg/kg of intravenous bevacizumab every 3 weeks. Study therapy continued until disease progression, unacceptable adverse event, or withdrawal of consent
126 studies on the registry are indexed under Meningeal Carcinomatosis; 43 are open to participants now.
This study's planned enrollment of 80 is above the median of 30 across 111 interventional studies indexed under Meningeal Carcinomatosis.
Browse Meningeal Carcinomatosis studies →Second Affiliated Hospital of Nanchang University is the lead sponsor of 81 studies on the registry; 49 are open to participants now.
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Exclusion Criteria:
Osimertinib 80 mg oral daily
Drug: Osimertinib
Osimertinib 80 mg oral daily; .bevacizumab 7.5 mg/kg intravenous every 3 weeks
Drug: Osimertinib · Drug: Bevacizumab
Treatment of LM With osimertinb
Also known as: AZD9291
Treatment of LM With osimertinb combined with bevacizumab
Also known as: Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb
Intracranial progression-free
iPFS (Time from LM diagnosis to the first documentation of intracranial lesion progression or death with documented intracranial pro- gression,)
Time frame: Every 6 weeks, up to 2 years,
Objective Response Rate
ORR, proportion of patients with a best overall response of complete response or partial response (CR+PR)
Time frame: Every 6 weeks, up to 2 years
LM Overall survival
LM-OS defined as time from LM diagnosis to death due to any cause or last follow-up
Time frame: Every 3 weeks, up to 5 years,
progression-free survival
Proportion of patients progression-free by investigator assessment per RECIST v1.1
Time frame: Every 6 weeks, up to 2 years,
adverse events
Number of patients with adverse events (AEs) as a measure of safety and tolerability
Time frame: Every 3 weeks, up to 2 years,
No study locations are listed for this record.
Plan to share: No
Start is estimated for Nov 2019; primary completion for Mar 2021, 16 months later.
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This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bevacizumab
Second Affiliated Hospital of Nanchang University