Ignite Creation Date:
2024-05-06 @ 12:30 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03778138
Status:
UNKNOWN
Last Update Posted:
2018-12-19
First Post:
2018-12-14
Brief Title:
Study of Anlotinib Combined With Pemetrexed in Patients With Advanced Nonsquamous NSCLC
Sponsor:
Henan Provincial Peoples Hospital
Organization:
Henan Provincial Peoples Hospital
Study Overview
Official Title:
Study of Anlotinib Combined With Pemetrexed as the Second-line Treatment in Patients With Advanced Nonsquamous Non-Small-Cell Lung Cancer ALTER-L025
Status:
UNKNOWN
Status Verified Date:
2018-12
Last Known Status:
RECRUITING
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:
ALTER-L025
Brief Summary:
In recent years with the progress in the treatment field NSCLC has become the most successful cancer species in precision medicine Patients with positive driving genes such as EGFR ALK ROS1 BRAF and so on have clearly targeted drugs which bring survival benefits to patientsHowever about 50 of patients still lack a clear driving gene target which has become the focus of current researchIn the field of wild-type NSCLC with negative driver genes the classic first-line treatment regimen is the two-drug regimen containing platinumhe phase II clinical study of pemetrexed in the second-line treatment of advanced non-small cell lung cancer patients with pemetrexed versus carboplatin pemetrexed showed that the median PFS time in the pemetrexed group was 35 months
Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and developmentIn the phase Ⅲ study patients who failed at least two kinds of systemic chemotherapy third line or beyond or drug intolerance were treated with anlotinib or placebo the anlotinib group PFS and OS were 537 months and 963 months the placebo group PFS and OS were 14 months and 63 months
The efficacy and safety of anrotinib combined with pemetrexed in the second-line treatment of advanced non-squamous and non-small cell patients deserve further exploration
Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and developmentIn the phase Ⅲ study patients who failed at least two kinds of systemic chemotherapy third line or beyond or drug intolerance were treated with anlotinib or placebo the anlotinib group PFS and OS were 537 months and 963 months the placebo group PFS and OS were 14 months and 63 months
The efficacy and safety of anrotinib combined with pemetrexed in the second-line treatment of advanced non-squamous and non-small cell patients deserve further exploration
Detailed Description:
This is a multicentre single arm clinical trial conducted in Chinathe purpose of this study is to evaluate and observe Anlotinib 12mg QD PO d1-14 21 days per cycle Combined With Pemetrexed500mgm2IVd121 days per cycle as the second-line Treatment in Patients With Advanced nonsquamous Non-Small-Cell Lung CancerAs the reportThe median PFS of advanced NSCLC treated by Pemetrexed as second-line was 3-35 monthsWe expect the median PFS of Anlotinib combined with Pemetrexed as the second-line Treatment in Patients With Advanced nonsquamous NSCLC was 6 monthsUsing PASS15 we calculated the sample size of this study was 46α0025β01 according to 10 censoringthe expected sample size is 51
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