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OPTIMAL: Erlotinib vs Chemotherapy in EGFR-mutant NSCLC

NCT00874419Phase 3

Key facts

Status: Completed
Start: Aug 2008
Primary completion: Jul 2010
Countries: 1
Sponsor: Tongji University
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 Tongji University. Primary endpoint: Progression-Free Survival at 12 months. Started Aug 2008; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Erlotinib
Erlotinib 150 mg oral, once a day until progression
Gemcitabine/Carboplatin
Gemcitabine 1000mg/m2 d1,8 + Carboplatin AUC=5 d1, q3w x 4 cycles

Who it enrols

Chemo-naive patients with Stage IIIB/IV NSCLC and confirmed EGFR exon 19 deletion or exon 21 L858R mutation.

Endpoints

Primary

Progression-Free Survival12 months

Secondary

Overall Survival24 months
Overall Response Rate24 months
Time to Progression24 months
Quality of Life24 months
Biological Markers24 months

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