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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
81
Krankenhaus Hietzing
Vienna, Austria
Institut Jules Bordet
Brussels, Belgium
Aarhus University Hospital
Aarhus, Denmark
University Hospital of Heraklion
Heraklion, Greece
National Institute of Oncology
Budapest, Hungary
St James's Hospital
Dublin, Ireland
Institution Rabin MC
Petah Tikwa, Israel
Tel-Aviv Medical Center
Tel Aviv, Israel
Medical Oncology, Second University Naples
Naples, Italy
Vercelli Teaching Hospital
Vercelli, Italy
...and 22 more locations
Progression-free Survival
Time from the date of randomization until documented progression or death without documented progression. Assessment of Progressive Disease (PD) based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) Target lesions:At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.(Note: the appearance of one or more new lesions is also considered progression). Non-target lesions:Unequivocal progression of existing non-target lesions. (Note:the appearance of one or more new lesions is also considered progression). To achieve 'unequivocal progression', there must be an overall level of substantial worsening in non-target disease such that,even in presence of SD or PR in target disease, the overall tumour burden has increased sufficiently
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.
Overall Survival
Defined as time from the date of randomization until death from any cause.
Time frame: All patients will be followed for survival status every 12 weeks up to 24 months after the last patient is randomized
Objective Response
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.
Time frame: Same as primary outcome: 24 months
Disease Control
Disease control is defined as achieving objective response or stable disease for at least 6 weeks.
Time frame: Same as primary outcome: 24 months
Number of Participants With Adverse Events
Adverse events classified according to NCI CTCAE version 4
Time frame: Same as primary outcome: 24 months
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