Trial intelligence / Profile preview

Anlotinib and Pemetrexed Maintenance in Non-Squamous NSCLC

NCT04453423Phase 2

Key facts

Status: Unknown
Start: Jul 2020
Primary completion: Jul 2022
Sponsor: Jiangsu Provincial People's Hospital
Modality: Small Molecules

Drugs: anlotinib
Conditions: Nonsquamous Non-Small Cell Lung Cancer (nsNSCLC)

Overview

Phase 2, randomised, open-label trial of anlotinib in Nonsquamous Non-Small Cell Lung Cancer (nsNSCLC) (4 arms), sponsored by Jiangsu Provincial People's Hospital. Primary endpoint: Progression-Free Survival at 6 months. Status: unknown.

Design

4 arms

Study design: RandomizedOpen-label

First-line Treatment
Anlotinib + Pemetrexed + Carboplatin
Maintenance Treatment A
Pemetrexed
Maintenance Treatment B
Anlotinib + Pemetrexed
Maintenance Treatment C
Anlotinib

Who it enrols

Adult patients (18-75) with locally advanced or advanced non-squamous NSCLC, ECOG 0-1, and no prior systemic anti-cancer therapy. Patients must not have tumor invading major blood vessels, significant hemoptysis, or recent use of full-dose anticoagulants.

Endpoints

Primary

Progression-Free Survival6 months

Secondary

Objective Response Rateup to 12 months
Disease Control Rateup to 12 months
Overall Survival12 months
Number of Participants with Adverse EventsUntil 30 day safety follow-up visit

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