Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-03-14 @ 8:38 AM
Study NCT ID:
NCT03755869
Status:
UNKNOWN
Last Update Posted:
2020-04-03
First Post:
2018-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Anlotinib in Non-squamous NSCLC Patients Who Failed First-Line（ALTER-L020）
Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Organization:
Study Overview
Official Title:
An Open, Single-arm, Multi-center Study of Anlotinib in Non-squamous NSCLC Patients Who Failed First-Line Chemotherapy
Status:
UNKNOWN
Status Verified Date:
2019-04
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:
None
Brief Summary:
Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor celltebiz related kinase -c-Kit kinase. In 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 (12mg, po. qd. on day 1to14 of a 21-day cycle) or placebo, the anlotinib group PFS and OS were 5.37 months and 9.63 months, the placebo group PFS and OS were 1.4 months and 6.3 months.
Detailed Description:
It is an open, single-arm, multi-center clinical trial conducted in China, and plan to Recruiting103 patients who were progressed after first line systemic therapy and refused/can't tolerate chemotherapy. Patents receive 12mg anlotinib orally daily on day 1to 14 of a 21-day cycle until progression of disease, assess safety and efficacy of the drug.
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?:
False
Is an FDA AA801 Violation?: