Ignite Creation Date:
2024-05-06 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05266846
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2022-02-18
Brief Title:
Pembrolizumab Plus Bevacizumab and Chemotherapy for ALK-rearranged NSCLC With Persistent 5ALK
Sponsor:
Hunan Province Tumor Hospital
Organization:
Hunan Province Tumor Hospital
Study Overview
Official Title:
Bevacizumab and Chemotherapy With or Without Pembrolizumab in First Line Alectinib Failed ALK-rearranged Advanced Lung Adenocarcinoma Patients With Persistent 5ALK A Phase II Randmized Control Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEYOND
Brief Summary:
This is an open-label multiple centers two-arms phase II study to evaluate the safety and efficacy PembrolizumabBevacizumab in combination with Chemotherapy could improve PFS in Alectinib Failed ALK-rearranged Advanced Lung Adenocarcinoma with Persistent 5ALK The eligible patients should have Stage IV Adenocarcinoma ALK-rearranged tested by NGS Perisitent with 5ALK Failed from first line Alectinib The patients should meet the physical requirements to receive Pembrolizumab Bevacizumab with Chemotherapy All the patients who meet these requirements will be enrolled in this study The eligible patients will be treated with Pembrolizumab 200 mg intravenously IV plus Bevacizumab 15mgkg Pemetrexed 500mgm2Carboplatin AUC4 for up to 4 cycles followed by Pembrolizumab 200mg Q3W Bevacizumab 15mgkgPemetrexed 500mgm2 for up to 31cycles or until disease progression intolerable toxicity or physician or participant decision
Detailed Description:
This is an open-label multiple centers two-arms phase II study to evaluate the safety and efficacy PembrolizumabBevacizumab in combination with Chemotherapy could improve PFS in Alectinib Failed ALK-rearranged Advanced Lung Adenocarcinoma with Persistent 5ALK The eligible patients should have Stage IV Adenocarcinoma ALK-rearranged tested by NGS Perisitent with 5ALK Failed from first line Alectinib The patients should meet the physical requirements to receive Pembrolizumab Bevacizumab with Chemotherapy All the samples were collected for single-RNA sequencing and DSP to evalutate the TME to predict the efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None