Anlotinib Combined With Pemetrexed And Carboplatin as First-line Treatment in Advanced Nonsquamous NSCLC

Non-squamous Cell Non-Small Cell Lung Cancer Clinical Trial

Official title: Anlotinib Combined With Pemetrexed And Carboplatin Followed by Maintenance Therapy With Anlotinib Plus Pemetrexed as the First-line Treatment in Patients With Advanced Nonsquamous NSCLC

Status Recruiting

Clinical Trial Summary

In recent years, with the progress in the treatment field, Non-Small Cell Lung Cancer(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.The study by Kimura T in the first-line treatment of 54 wild-type advanced NSCLC patients with carboplatin and pemetrexed showed that the ORR, mPFS and mOS of patients with wild-type non-squamous NSCLC treated with carboplatin permetrexine were 35.8%, 5.4 months and 12.7 months respectively.

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 9.46 months, the placebo group PFS and OS were 1.4 months and 6.37 months.

The efficacy and safety of Anlotinib combined with Pemetrexed and Carboplatin followed by maintenance therapy with Anlotinib plus Pemetrexed as the first-line treatment in patients with advanced nonsquamous NSCLC deserve further exploration.

Clinical Trial 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,d15-21,21 days per cycle)and Carboplatin(AUC5,IV,d15-21,21 days per cycle,4 cycles) as the first-line treatment in patients with advanced nonsquamous NSCLC .After four cycles of induction,patients continued to receive Anlotinib and Pemetrexed.As the report,The median PFS of advanced NSCLC treated by Pemetrexed and Carboplatin was 6 months.We expect the median PFS of Anlotinib combined with Pemetrexed and Carboplatin as the first-line treatment in patients with advanced nonsquamous NSCLC was 10 months.Using PASS15, we calculated the sample size of this study was 34(α=0.05、β=0.2), according to 20% censoring,the expected sample size is 43. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-squamous Cell Non-Small Cell Lung Cancer

• NCT number: NCT03790228
• Study type: Interventional
• Source: Henan Cancer Hospital
• Contact: Qiming Wang, Doctor
• Phone: 0086-13783590691
• Email: mysubmission@126.com
• Status: Recruiting
• Phase: Phase 1
• Start date: March 22, 2019
• Completion date: August 31, 2021