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Famitinib plus Docetaxel in Advanced Non-Squamous NSCLC

NCT02766140Phase 3

Key facts

Status: Terminated
Start: Jun 2016
Primary completion: Nov 2016
Countries: 1
Sponsor: Hengrui
Modality: Small Molecules

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

Overview

Phase 3, randomised, double-blind trial in Nonsquamous Non-Small Cell Lung Cancer (nsNSCLC) comparing Famitinib + Docetaxel with Placebo + Docetaxel (2 arms). Primary endpoint: Overall Survival. Started Jun 2016; status: terminated.

Design

2 arms

Study design: RandomizedDouble-blind

Famitinib + Docetaxel
Famitinib (SHR1020) 20mg qd days 2-21 + Docetaxel 60 mg/m^2 IV Day 1 every 3 weeks.
Placebo + Docetaxel
Placebo qd days 2-21 + Docetaxel 60 mg/m^2 IV Day 1 every 3 weeks.

Endpoints

Primary

Overall Survivalapproximately 30 months

Secondary

Progression Free Survivalapproximately 30 months
Incidence and Intensity of Adverse Events
Objective Tumour Responseapproximately 30 months
Disease Controlapproximately 30 months
Quality of Lifeapproximately 30 months

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