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

Nanjing Medical University

Status and phase: Unknown; Phase 2

Conditions: Non-squamous Non-small-cell Lung Cancer

Treatments: Drug: Anlotinib; Drug: Pemetrexed; Drug: Anlotinib + Pemetrexed+Carboplatin; Drug: Anlotinib + Pemetrexed

Study type: Interventional

Funder types: Other

Identifiers

NCT04453423

AN001

Details and patient eligibility

About

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).

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 4 patient groups

First-line Treatment

Other group

Treatment:

Drug: Anlotinib + Pemetrexed+Carboplatin

Maintenance Treatment A

Experimental group

Treatment:

Drug: Pemetrexed

Maintenance Treatment B

Experimental group

Treatment:

Drug: Anlotinib + Pemetrexed

Maintenance Treatment C

Experimental group

Treatment:

Drug: Anlotinib