Trial intelligence / Profile preview

Optimization of Erlotinib in Advanced NSCLC (TAILOR)

NCT00637910Phase 3

Key facts

Status: Unknown
Start: Nov 2007
Primary completion: Feb 2012
Countries: 1
Sponsor: ASST Fatebenefratelli Sacco
Modality: Small Molecules

Drugs: erlotinib
Conditions: non-small cell lung cancer (NSCLC)

Overview

Phase 3, randomised, open-label trial of erlotinib in non-small cell lung cancer (NSCLC) (2 arms), sponsored by ASST Fatebenefratelli Sacco. Primary endpoint: Overall Survival. Status: unknown.

Design

2 arms

Study design: RandomizedOpen-label

Erlotinib Arm
Erlotinib 150 mg/day
Docetaxel Arm
Docetaxel 75 mg/m2 q3w or 35 mg/m2 weekly

Endpoints

Primary

Overall Survival12 months after last patient randomized

Secondary

Progression Free Survival4 years
Objective Response Rate4 years
Quality of Life4 years
Toxicity and Serious Adverse Reactions4 years

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