临床试验/NCT04453423

NCT04453423Unknown2 期

A Study of the Effect of Anlotinib, Pemetrexed or the Combination As Maintenance Therapy for Patients With Non-Squamous Non-Small Cell Lung Cancer.

The First Affiliated Hospital with Nanjing Medical University0 个研究点目标入组 90 人开始时间: 2020年7月1日最近更新: 2020年7月1日

适应症

干预措施

试验速览

阶段: 2 期
发起方: The First Affiliated Hospital with Nanjing Medical University
入组人数: 90
主要终点: Progression-Free Survival (PFS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study will compare maintenance therapy with anlotinib plus pemetrexed versus pemetrexed or anlotinib alone, in patients with Non-squamous Non-small cell lung cancer who have not progressed during first-line therapy with anlotinib + pemetrexed + carboplatin. The primary endpoint of the study is progression-free survival (PFS); the secondary endpoints are disease control rate (DCR), objective response rate (ORR) and overall survival (OS).

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age ≥ 18 years and ≤ 75, ECOG PS: 0~1, estimated survival duration more than 3 months;
•Subjects with histologically or cytologically confirmed locally advanced and/or advanced Non-squamous NSCLC;
•Signed and dated informed consent;
•adequate hematological, liver and renal function

排除标准

•prior chemotherapy or treatment with another systemic anti-cancer agent
•malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS
•evidence of tumor invading major blood vessels
•current or recent use of aspirin (>325mg/day) or full-dose anticoagulants or thrombolytic agents for therapeutic purposes
•history of haemoptysis >/=grade 2
•clinically significant cardiovascular disease

研究组 & 干预措施

First-line Treatment

Other

干预措施: Anlotinib + Pemetrexed+Carboplatin (Drug)

Maintenance Treatment A

Experimental

干预措施: Pemetrexed (Drug)

Maintenance Treatment B

Experimental

干预措施: Anlotinib + Pemetrexed (Drug)

Maintenance Treatment C

Experimental

干预措施: Anlotinib (Drug)

结局指标

主要结局

Progression-Free Survival (PFS)

时间窗: 6 months

PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause.

次要结局

Objective Response Rate (ORR)(each 42 days up to intolerance the toxicity or PD (up to 12 months))
Disease control rate (DCR)(each 42 days up to intolerance the toxicity or PD (up to 12 months))
Overall Survival (OS)(12 months)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Until 30 day safety follow-up visit)

研究者

发起方

The First Affiliated Hospital with Nanjing Medical University

申办方类型

Other

责任方

Sponsor

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