A prospective, open-label, multi-center, single-arm study of Almonertinib combined With Bevacizumab for EGFR-mutant NSCLC patients with leptomeningeal metastasis.
This is a prospective, open-label, multi-center, single-arm study to evaluate the efficacy and safety of Almonertinib combined with Bevacizumab for EGFR-mutant NSCLC patients with leptomeningeal metastasis. ALL patients were treated with Almonertinib 110mg oral daily and Bevacizumab 15mg/kg intravenous every 3 weeks. Study therapy continued until disease progression, unacceptable adverse event, or withdrawal of consent.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
69
110 mg oral once daily
15 mg/kg intravenous on Day 1 of 21 day cycles (every 3 weeks)
The Second Afiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Overall Survival (OS)
OS is the time from the date of enrollment until death due to any cause
Time frame: From date of enrollment until the date of death, up to 2 years
Time to Symptom Resolution
Time to symptom resolution is the time from first drug dosage date (C1D1) until the date of symptom resolution
Time frame: From baseline, then every 3 weeks, up to 2 years
Progression Free Survival (PFS)
PFS is the time from date of enrollment until the date of PD (by investigator assessment) or death
Time frame: From baseline, then every 6 weeks, up to 2 years
Objective Response Rate (ORR)
ORR is the proportion of patients with a best overall response of complete response or partial response (CR+PR)
Time frame: From baseline, then every 6 weeks, up to 2 years
Disease Control Rate (DCR)
DCR is the proportion of patients with a best overall response of complete response, partial response or stable disease(CR+PR+SD)
Time frame: From baseline, then every 6 weeks, up to 2 years
Duration of Response (DoR)
DoR is the time from date of first documented response until the date of PD (by investigator assessment) or death
Time frame: From baseline, then every 6 weeks, up to 2 years
Intracranial Progression Free Survival (iPFS)
Intracranial progression-free survival
Time frame: From baseline, then every 6 weeks, up to 2 years
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Intracranial Objective Response Rate (iORR)
Intracranial objective response rate
Time frame: From baseline, then every 6 weeks, up to 2 years
Intracranial Disease Control Rate (iDCR)
Intracranial disease control rate
Time frame: From baseline, then every 6 weeks, up to 2 years
Intracranial Duration of Response (iDoR)
Intracranial duration of response
Time frame: From baseline, then every 6 weeks, up to 2 years
Extracranial Progression Free Survival (ePFS)
Extracranial progression-free survival
Time frame: From baseline, then every 6 weeks, up to 2 years
Extracranial Objective Response Rate (eORR)
Extracranial objective response rate
Time frame: From baseline, then every 6 weeks, up to 2 years
Extracranial Disease Control Rate (eDCR)
Extracranial disease control rate
Time frame: From baseline, then every 6 weeks, up to 2 years
Extracranial Duration of Response (eDoR)
Extracranial duration of response
Time frame: From baseline, then every 6 weeks, up to 2 years
Assess the safety of Almonertinib Combined With Bevacizumab
Number of adverse events (AEs)/serious adverse events (SAEs)
Time frame: From baseline, then every 3 weeks, up to 2 years