Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557096
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
CSF CTC-Capture-Guided EGFR-TKI and Bevacizumab Combination Therapy in EGFR-Mutant Advanced NSCLC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Open-label Single-Arm Multicenter Clinical Study of EGFR-TKIs Sequentially Combined With Bevacizumab for the Treatment of EGFR-Mutant Advanced Non-Small Cell Lung Cancer Based on Early Warning by CSF CTC Capture Technology
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
clinical trial The goal of this clinical trial is to learn whether the treatment of advanced non-small cell lung cancer with EGFR-TKIs when combined with bevacizumab in the presence of positive circulating tumor cells in the cerebrospinal fluid has better therapeutic efficacy The main questions it aims to answer are1When EGFR-TKIs are sequentially combined with bevacizumab along with EGFR-TKIs for first-line treatment of advanced non-small cell lung cancer how long can the participants survive 2What medical problems do participants have when using EGFR-TKIs sequentially combined with bevacizumab in conjunction with EGFR-TKIs
Participants will
Receive EGFR-TKIs treatment for a duration of 3 months and upon a positive cerebrospinal fluid tumor cell status subsequently receive bevacizumab combined with EGFR-TKIs treatment until disease progression
Visit the clinic for check-ups and tests every two weeks and have follow-up visits every six weeks after the treatment ends
Keep a record of their symptoms and disease progression
Participants will
Receive EGFR-TKIs treatment for a duration of 3 months and upon a positive cerebrospinal fluid tumor cell status subsequently receive bevacizumab combined with EGFR-TKIs treatment until disease progression
Visit the clinic for check-ups and tests every two weeks and have follow-up visits every six weeks after the treatment ends
Keep a record of their symptoms and disease progression
Detailed Description:
This study is an open-label single-arm multicenter exploratory clinical trial designed to evaluate and observe the first-line treatment of locally advancedadvanced non-small cell lung cancer that is positive for EGFR mutations based on the early warning of a novel cerebrospinal fluid CTC capture technology Subjects who meet all inclusion criteria and none of the exclusion criteria will first receive EGFR-TKIs osimertinib amivantamab or futibatinib treatment as per the instruction manual After a positive cerebrospinal fluid tumor cell status they will then sequentially receive bevacizumab 75mgkg intravenous injection once every 3 weeks combined with EGFR-TKIs treatment
Participants Aged 18 years or older including 18 years old and up to 75 years of age including 75 years old confirmed non-small cell lung cancer through histology or cytology confirmed EGFR sensitive mutation exon 19 deletion or L858R prior to treatment planned to receive first-line monotherapy with EGFR-TKIs osimertinib amivantamab or futibatinib
This study is an open-label single-arm multicenter exploratory clinical trial The primary research objective is to evaluate the overall survival time OS of patients with locally advancedadvanced EGFR-mutant non-small cell lung cancer NSCLC treated with EGFR tyrosine kinase inhibitors EGFR-TKIs sequentially combined with bevacizumab as a first-line treatment based on the early warning of a novel cerebrospinal fluid circulating tumor cell CSF CTC capture technology The study endpoint is the overall survival time OS of the patients Referring to the results of our teams prospective study data and historical literature review study data it is anticipated that the hazard ratio HR for overall survival OS of EGFR-TKIs sequentially combined with bevacizumab compared to EGFR-TKIs as a first-line treatment for high-risk patients with EGFR-mutant locally advancedadvanced NSCLC and leptomeningeal metastasis will be 078 median OS improved from 18 months to 21 months After the first subject is enrolled with the longest observation period being 24 months α set at two-sided 005 and a power of 80 calculating with a 25 CSF tumor cell positivity rate and a 10 loss to follow-up rate using the NCSSPASS 150 software and the single-sample Logrank test method after sample correction this study plans to enroll approximately 100 subjects
Based on the investigator-assessed Overall Survival OS as the primary efficacy endpoint the median survival time will be estimated using the Kaplan-Meier method and the median event time along with its two-sided 95 confidence interval will be presented Additionally the hazard ratio and its 95 confidence interval will be estimated as the main analysis
Participants Aged 18 years or older including 18 years old and up to 75 years of age including 75 years old confirmed non-small cell lung cancer through histology or cytology confirmed EGFR sensitive mutation exon 19 deletion or L858R prior to treatment planned to receive first-line monotherapy with EGFR-TKIs osimertinib amivantamab or futibatinib
This study is an open-label single-arm multicenter exploratory clinical trial The primary research objective is to evaluate the overall survival time OS of patients with locally advancedadvanced EGFR-mutant non-small cell lung cancer NSCLC treated with EGFR tyrosine kinase inhibitors EGFR-TKIs sequentially combined with bevacizumab as a first-line treatment based on the early warning of a novel cerebrospinal fluid circulating tumor cell CSF CTC capture technology The study endpoint is the overall survival time OS of the patients Referring to the results of our teams prospective study data and historical literature review study data it is anticipated that the hazard ratio HR for overall survival OS of EGFR-TKIs sequentially combined with bevacizumab compared to EGFR-TKIs as a first-line treatment for high-risk patients with EGFR-mutant locally advancedadvanced NSCLC and leptomeningeal metastasis will be 078 median OS improved from 18 months to 21 months After the first subject is enrolled with the longest observation period being 24 months α set at two-sided 005 and a power of 80 calculating with a 25 CSF tumor cell positivity rate and a 10 loss to follow-up rate using the NCSSPASS 150 software and the single-sample Logrank test method after sample correction this study plans to enroll approximately 100 subjects
Based on the investigator-assessed Overall Survival OS as the primary efficacy endpoint the median survival time will be estimated using the Kaplan-Meier method and the median event time along with its two-sided 95 confidence interval will be presented Additionally the hazard ratio and its 95 confidence interval will be estimated as the main analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None