NCT04453423

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
DRUG	Pemetrexed	500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase)
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)
DRUG	Anlotinib	12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase)

Timeline

• Start date: 2020-07-01
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2020-07-01
• Last updated: 2020-07-01