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

Phase 2

• Conditions: Non-squamous Non-small-cell Lung Cancer
• Interventions: Drug: Anlotinib + Pemetrexed+Carboplatin; Drug: Anlotinib + Pemetrexed; Drug: Pemetrexed; Drug: Anlotinib

• Registration Number: NCT04453423
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-27
• Study First Submitted QC: 2020-06-27
• Last Update Submitted: 2020-06-27
• Study Start: 2020-07-01
• Study First Posted: 2020-07-01
• Last Update Posted: 2020-07-01
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
First-line Treatment	Anlotinib + Pemetrexed+Carboplatin	-
Maintenance Treatment B	Anlotinib + Pemetrexed	-
Maintenance Treatment A	Pemetrexed	-
Maintenance Treatment C	Anlotinib	-

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	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.

Secondary Outcome Measures

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