Trial intelligence / Profile preview

Vorinostat + Paclitaxel/Carboplatin in Advanced NSCLC

NCT00473889Phase 3

Key facts

Status: Terminated
Start: May 2007
Primary completion: Dec 2008
Sponsor: Merck & Co.
Modality: Covalent Small Molecules, Classical Binding Small Molecules

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

Overview

Phase 3, randomised, double-blind trial in non-small cell lung cancer (NSCLC) comparing Vorinostat Arm with Placebo Arm (2 arms). Primary endpoint: Overall Survival. Started May 2007; status: terminated.

Design

2 arms

Study design: RandomizedDouble-blind

Vorinostat Arm
Vorinostat 400 mg daily + Paclitaxel 200 mg/m2 + Carboplatin AUC 6
Placebo Arm
Placebo + Paclitaxel 200 mg/m2 + Carboplatin AUC 6

Who it enrols

Patients with Stage IIIB (with pleural effusion) or Stage IV NSCLC, no prior systemic treatment, and not eligible for bevacizumab.

Endpoints

Primary

Overall SurvivalStart of treatment to death

Secondary

Progression Free SurvivalStart of treatment to disease progression or death
Objective Response RateEvery 42 days

Results

Not all primary endpoints met

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