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

• Status: Not yet recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Treatments: Carboplatin; Pemetrexed

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