Trial intelligence / Profile preview

Gefitinib vs Platinum-Based Chemotherapy in EGFR FISH Positive NSCLC

NCT00807066Phase 3

Key facts

Status: Completed
Start: Nov 2008
Primary completion: Nov 2009
Countries: 1
Sponsor: Humanitas per la Ricerca
Modality: Small Molecules

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

Overview

Phase 3, randomised, open-label trial of gefitinib in non-small cell lung cancer (NSCLC) (2 arms), sponsored by Humanitas per la Ricerca. Primary endpoint: Quality of Life (FACT-L Total Score). Started Nov 2008; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Gefitinib
Gefitinib 250 mg/day
Platinum Chemotherapy
Platinum based chemotherapy with cycles every 21 days

Who it enrols

Patients with locally advanced or metastatic non-squamous NSCLC, EGFR FISH positive, candidate for first-line platinum-based chemotherapy, ECOG 0-2, and no prior chemotherapy or EGFR targeting agents.

Endpoints

Primary

Quality of Life (FACT-L Total Score)Every 3 weeks

Secondary

Time to Disease ProgressionEvery 2 months
Objective Response RateEvery 2 months
Overall SurvivalEvery 2 months
TolerabilityEvery 2 months

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