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

Non-squamous Non-small-cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04453423
• Other study ID #: AN001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: June 2020
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Renhua Guo, MD
• Phone: 025-68136360
• Email: rhguo[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-squamous Non-small-cell Lung Cancer

Intervention

Drug:
• Anlotinib + Pemetrexed+Carboplatin
Anlotinib: 12mg, QD, PO, d1-14, 21 days per cycle Carboplatin: AUC 5 on day 1 of 21 days per cycle Pemetrexed: 500mg/m2 iv on day 1 of 21 days per cycle
• Pemetrexed
500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase)
• Anlotinib + Pemetrexed
Anlotinib:12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase) Pemetrexed:500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase)
• Anlotinib
12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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).	each 42 days up to intolerance the toxicity or PD (up to 12 months)
Secondary	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).	each 42 days up to intolerance the toxicity or PD (up to 12 months)
Secondary	Overall Survival (OS)	OS is calculated from diagnosis to death or last follow-up time.	12 months
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Until 30 day safety follow-up visit