NCT01652469

Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®.

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: ETOP IBCSG Partners Foundation · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 significant interaction). 5. 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. 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

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Erlotinib	Erlotinib 150 mg/day p.o. continuously with 21 days cycle.
DRUG	Docetaxel	Docetaxel 75 mg/m2 as an IV infusion every 21 days.

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2012-07-30
• Last updated: 2022-08-24
• Results posted: 2019-08-08

Locations

32 sites across 12 countries: Austria, Belgium, Denmark, Greece, Hungary, Ireland, Israel, Italy, Netherlands, Spain, Switzerland, United Kingdom