Ignite Creation Date:
2024-05-06 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03671538
Status:
UNKNOWN
Last Update Posted:
2018-09-17
First Post:
2018-09-13
Brief Title:
Non Squamous NSCLC Patients With Anlotinib Combined With Pemetrexed and Cisplatin
Sponsor:
Lingyu Luo
Organization:
The First Affiliated Hospital of Nanchang University
Study Overview
Official Title:
A Randomized Phase II Study of Anlotinib Combined With Pemetrexed and Cisplatin in First Treatment for Advanced Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Negative Mutations
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
NOT_YET_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:
None
Brief Summary:
Chemotherapy is still the standard first-line treatment option for EGFR unmutated patients After a randomized phase Ⅲ trial BEYOND was presented the synergistic effect of progression-free survivalPFS could be expected when chemotherapy is combined with Antiangiogenesis agent bevacizumab in ChinaThereforein this study The investigators will investigate the efficacy and safety of Anlotinb combined With Pemetrexed and Cisplatin as first-line therapy in patients with chemotherapy-naive stage IIIB or IV non-squamous NSCLC without targetable EGFR or ALK genetic aberrations
Detailed Description:
This is a randomized single -center study conducted in China to compare the efficacy and safety of Anlotinb combined With Pemetrexed and Cisplatin as first-line therapy in patients of Advanced Gene Negative Non-squamous Non-small Cell Lung Cancer
Eligible patients will be randomized to arm A
Patients were instructed to take 500mgm2 pemetrexed as a 10-minute intravenous infusion and Cisplatin 75mgm2 on day 1 of a 21-day cycle and12mg Anlotinib orally daily on day 1 to 14 of a 21-day cycleIf there was no evidence of disease progression following a maximum of 4-6 cycles of anlotinib plus chemotherapy patients continued to receive single-agent anlotinib until disease progression or unacceptable toxicity Approximately 62 patients will be enrolled to ensure complete treatments for primary endpoint analysis
Eligible patients will be randomized to arm A
Patients were instructed to take 500mgm2 pemetrexed as a 10-minute intravenous infusion and Cisplatin 75mgm2 on day 1 of a 21-day cycle and12mg Anlotinib orally daily on day 1 to 14 of a 21-day cycleIf there was no evidence of disease progression following a maximum of 4-6 cycles of anlotinib plus chemotherapy patients continued to receive single-agent anlotinib until disease progression or unacceptable toxicity Approximately 62 patients will be enrolled to ensure complete treatments for primary endpoint analysis
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