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

NCT ID: NCT04453423

Last Updated: 2020-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-07-01

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).

Conditions

Non-squamous Non-small-cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

First-line Treatment

Group Type: OTHER

Anlotinib + Pemetrexed+Carboplatin

Intervention Type: DRUG

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

Maintenance Treatment A

Group Type: EXPERIMENTAL

Pemetrexed

Intervention Type: DRUG

500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase)

Maintenance Treatment B

Group Type: EXPERIMENTAL

Anlotinib + Pemetrexed

Intervention Type: DRUG

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)

Maintenance Treatment C

Group Type: EXPERIMENTAL

Anlotinib

Intervention Type: DRUG

12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase)

Interventions

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

Intervention Type: DRUG

Pemetrexed

500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase)

Intervention Type: DRUG

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)

Intervention Type: DRUG

Anlotinib

12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Renhua Guo, MD

Role: CONTACT

rhguo@njmu.edu.cn

025-68136360

Other Identifiers

AN001

Identifier Type: -

Identifier Source: org_study_id