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
Goals of the study:
1. Explore the predictive ability of the VeriStrat signature, by testing for interaction
between treatment arms (Arm A: erlotinib vs Arm B: docetaxel) and VeriStrat status (VSG
vs VSP) using as outcome progression free survival.
2. Explore whether treatment with erlotinib provides progression free survival benefit as
compared to docetaxel in the VSG group.
3. Compare progression free survival in the two treatment arms (Arm A: erlotinib vs Arm B:
docetaxel) in the VSP group.
4. Explore the prognostic ability of the VeriStrat signature by testing for an overall
difference in progression free survival between the two VeriStrat groups (in case of no
5. Explore the predictive ability of the VeriStrat signature using the secondary measures
of clinical efficacy including overall survival, objective response rate, and disease
6. Compare overall survival, objective response rate and disease control rate between
treatment groups separately in the VSG and VSP groups.
7. Explore the prognostic ability of the VeriStrat signature by testing for an overall
difference in overall survival, objective response rate and disease control rate
between the two VeriStrat groups (in case of no significant interaction).
8. Assess the safety and the tolerability of the two treatments separately in each
VeriStrat group and overall.
Recruitment period: 18 months Sample Size: 500
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time from the date of randomization until documented progression or death without documented progression.
The combined run in period, treatment and follow-up for PFS is expected to extend the study duration to a total of 24 months.
Solange Peters, MD-PhD
Centre Pluridisciplinaire d'Oncologie, Centre Hospitalier Universitaire Vaudois, 1011 Lausanne, Switzerland