At a glance
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A Randomized Phase III Trial of Erlotinib Versus Docetaxel in Patients With Advanced Squamous Cell Non-small Cell Lung Cancer Who Failed First Line Platinum Based Doublet Chemotherapy Stratified by VeriStrat Good vs VeriStrat Poor
In Brief
A Phase 3 clinical trial evaluating Erlotinib and Docetaxel for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 81 participants across 32 sites in 12 countries.
Detailed Summary
Using a laboratory test (VeriStrat), patients with relapsed squamous cell lung cancer are assigned to two strata, VSG (VeriStrat Good) and VSP (VeriStrat Poor). They are then randomized between an EGFR-TK inhibitor (erlotinib) and chemotherapy (Docetaxel). It is hypothesized that the VeriStrat test results are able to predict the benefit of treatment with erlotinib vs docetaxel. This would suggest a significant improvement in progression-free survival for VSG patients when treated with Erlotinib, and no significant improvement in VSP patients who receive the same treatment.
Study Details
Timeline
Interventions
Erlotinib 150 mg/day p.o. continuously with 21 days cycle.
Docetaxel 75 mg/m2 as an IV infusion every 21 days.