Trial intelligence / Profile preview

EUCROSS: Crizotinib in ROS1-positive Lung Adenocarcinoma

NCT02183870Phase 2

Key facts

Status: Completed
Start: May 2014
Primary completion: Jul 2018
Countries: 3
Sponsor: University of Cologne
Modality: Small Molecules

Drugs: crizotinib
Conditions: lung adenocarcinoma

Overview

Phase 2, open-label, single-arm trial of crizotinib in lung adenocarcinoma, sponsored by University of Cologne. Primary endpoint: Objective Response Rate at 12 months. Started May 2014; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Crizotinib
Single arm receiving Crizotinib 250 mg b.i.d.

Who it enrols

Patients with locally advanced or metastatic adenocarcinoma of the lung harbouring ROS1 translocations, ECOG 0-2, and adequate organ function. Prior ALK/ROS1 inhibitors are excluded.

Endpoints

Primary

Objective Response Rate12 months

Secondary

Progression Free Survival12 months
Overall Survival24 months
Duration of Response12 months
Time to Tumor Response3 months
Disease Control Rate24 weeks
Safety/Adverse Events and tolerability12 months
Patient Reported Outcomesmonthly

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