NCT03778138

Study of Anlotinib Combined With Pemetrexed in Patients With Advanced Nonsquamous NSCLC

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Henan Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 patients.However, about 50% of patients still lack a clear driving gene target, which has become the focus of current research.In the field of wild-type NSCLC with negative driver genes, the classic first-line treatment regimen is the two-drug regimen containing platinum.he 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 3.5 months. Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development.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 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. 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 China,the purpose of this study is to evaluate and observe Anlotinib (12mg QD PO d1-14, 21 days per cycle) Combined With Pemetrexed(500mg/m2,IV,d1,21 days per cycle) as the second-line Treatment in Patients With Advanced nonsquamous Non-Small-Cell Lung Cancer.As the report,The median PFS of advanced NSCLC treated by Pemetrexed as second-line was 3-3.5 months.We expect the median PFS of Anlotinib combined with Pemetrexed as the second-line Treatment in Patients With Advanced nonsquamous NSCLC was 6 months.Using PASS15, we calculated the sample size of this study was 46(α=0.025、β=0.1), according to 10% censoring,the expected sample size is 51.

Conditions

• Non-squamous Cell Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Anlotinib plus Pemetrexed	Anlotinib(12mg QD PO d1-14, 21 days per cycle) plus Pemetrexed (500mg/m2 IV d1)

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-12-31
• Completion: 2020-12-31
• First posted: 2018-12-19
• Last updated: 2018-12-19

Locations

1 site across 1 country: China