Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®. (EMPHASIS)
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Progression-free survival [ Time Frame: The combined run in period, treatment and follow-up for PFS is expected to extend the study duration to a total of 24 months. ] [ Designated as safety issue: No ]Time from the date of randomization until documented progression or death without documented progression.
- Overall survival [ Time Frame: All patients will be followed for survival status every 12 weeks up to 24 months after the last patient is randomized ] [ Designated as safety issue: No ]Defined as time from the date of randomization until death from any cause.
- Objective response [ Time Frame: Same as primary outcome: 24 months ] [ Designated as safety issue: No ]Objective response is defined as best overall response (CR or PR) across all assessment time-points according to RECIST Criteria 1.1 during the period from randomization to termination of trial treatment.
- Disease control [ Time Frame: Same as primary outcome: 24 months ] [ Designated as safety issue: No ]Disease control is defined as achieving objective response or stable disease for at least 6 weeks.
- Toxicities of treatment [ Time Frame: Same as primary outcome: 24 months ] [ Designated as safety issue: Yes ]Adverse events classified according to NCI CTCAE version 4
|Study Start Date:||August 2012|
|Study Completion Date:||December 2015|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: A: Erlotinib
Erlotinib in standard dose. Until progression (clinical or radiological) or unacceptable toxicity.
Erlotinib 150 mg/day p.o. continuously with 21 days cycle.
Other Name: Tarceva (Roche)
Experimental: B: Docetaxel
Docetaxel in standard dose. Until progression (clinical or radiological) or unacceptable toxicity.
Docetaxel 75 mg/m2 as an IV infusion every 21 days.
Other Name: Taxotere (Sanofi-Aventis)
Goals of the study:
- 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.
- Explore whether treatment with erlotinib provides progression free survival benefit as compared to docetaxel in the VSG group.
- Compare progression free survival in the two treatment arms (Arm A: erlotinib vs Arm B: docetaxel) in the VSP group.
- 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 significant interaction).
- Explore the predictive ability of the VeriStrat signature using the secondary measures of clinical efficacy including overall survival, objective response rate, and disease control rate.
- Compare overall survival, objective response rate and disease control rate between treatment groups separately in the VSG and VSP groups.
- 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).
- Assess the safety and the tolerability of the two treatments separately in each VeriStrat group and overall.
Recruitment period: 18 months Sample Size: 500
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652469
Show 32 Study Locations
|Study Chair:||Solange Peters, MD-PhD||Centre Pluridisciplinaire d'Oncologie, Centre Hospitalier Universitaire Vaudois, 1011 Lausanne, Switzerland|
|Study Chair:||Egbert Smit, MD-PhD||Vrije Universiteit VU, Medical Centre, 1007MB Amsterdam, The Netherlands|
|Study Chair:||Rolf Stahel, MD||Laboratory of Molecular Oncology, Clinic of Oncology, University Hospital Zürich, 8044 Zürich, Switzerland|