NCT03755869

Study of Anlotinib in Non-squamous NSCLC Patients Who Failed First-Line（ALTER-L020）

An Open, Single-arm, Multi-center Study of Anlotinib in Non-squamous NSCLC Patients Who Failed First-Line Chemotherapy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 103 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-squamous NSCLC

Interventions

Type	Name	Description
DRUG	Anlotinib	Anlotinib ( 12mg, QD, PO, d1-14, 21 days per cycle), take once when limosis in the morning. If patients cannot suffer from AEs, they can get declined dosage.

Timeline

• Start date: 2018-11-29
• Primary completion: 2021-11-01
• Completion: 2021-12-01
• First posted: 2018-11-28
• Last updated: 2020-04-03

Locations

1 site across 1 country: China