Combination Chemotherapy With or Without Anlotinib in the Maintenance Treatment of Non-Squamous Non-Small Cell Lung Cancer.

The First Affiliated Hospital with Nanjing Medical University90 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-squamous Non-small-cell Lung Cancer

Interventions

Anlotinib + Pemetrexed+Carboplatin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 18 years and ≤ 75, ECOG PS: 0\~1, estimated survival duration more than 3 months; 2. Subjects with histologically or cytologically confirmed locally advanced and/or advanced Non-squamous NSCLC; 3. Signed and dated informed consent; 4. adequate hematological, liver and renal function Exclusion Criteria: 1. prior chemotherapy or treatment with another systemic anti-cancer agent 2. 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 3. evidence of tumor invading major blood vessels 4. current or recent use of aspirin (\>325mg/day) or full-dose anticoagulants or thrombolytic agents for therapeutic purposes 5. history of haemoptysis \>/=grade 2 6. clinically significant cardiovascular disease

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

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

Time frame: 6 months

Secondary Outcomes

Objective Response Rate (ORR)

Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1). The percentage of patients who achieved CR and PR was defined as objective response rate (ORR).

Time frame: each 42 days up to intolerance the toxicity or PD (up to 12 months)

Disease control rate (DCR)

Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1) and the percentage of patients who achieved CR, PR and SD was defined as disease control rate (DCR).

Time frame: each 42 days up to intolerance the toxicity or PD (up to 12 months)

Overall Survival (OS)

OS is calculated from diagnosis to death or last follow-up time.

Time frame: 12 months

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time frame: Until 30 day safety follow-up visit