Squamous cell non-small cell lung cancer in patients who have failed first-line platinum-based doublet chemotherapy. MedDRA version: 14.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ERLOTINIB HYDROCHLORIDE
CAS Number: 183319-69-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
P
Sponsors
ETOP (European Thoracic Oncology Platform)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically or cytologically confirmed locally advanced stage IIIB, not amenable to radical radiotherapy, or metastatic stage IV non-small cell lung cancer (NSCLC) of predominant squamous subtype, according to the 7th edition of the TNM classification, including M1a (separate tumor nodule in a contralateral lobe, tumor with pleural nodules or malignant pleural or pericardial effusion) and/or M1b (distant metastasis). - Progressive disease upon or after previous chemotherapy including at least one line of platinum-based chemotherapy. - Adjuvant platinum-based chemotherapy can be considered as platinum-based chemotherapy line if administration ended in the 6 months before registration. - Platinum-based chemotherapy combined with definitive radiotherapy can be considered as platinum-based chemotherapy line if administration ended in the 6 months before registration. Measurable or evaluable disease according to RECIST v1.1 . ECOG performance status 0-2. - Age = 18 years. - Adequate organ function, including: - Adequate bone marrow reserve: ANC > 1.5 x 109/L, platelets > 100 x 109/L. - Hepatic: bilirubin 40 ml/min based on the Cockroft and Gault formula. - Signed and dated informed consent form. - Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with reproductive potential must have a negative serum or urin pregnancy test within 7 days prior to study registration. Non-reproductive potential for females is defined as surgically sterile or post-menopausal defined as =24 months since last menses. Male patients are considered to have reproductive potential unless they are surgically sterile. - Estimated life expectancy >12 weeks. - Patient compliance and geographical proximity that allow adequate follow-up. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: - Evidence of other medical conditions which would impair the ability of the patient to participate in the trial or might preclude therapy with trial drugs (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease, active infection, uncontrolled diabetes mellitus). - Previous treatment with any EGFR-TKI or docetaxel. - Documented brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least 14 days prior to registration. - Documented presence of activating EGFR mutations, if patient was tested for EGFR mutations. - Previous malignancy within 5 years with the exception of adequately treated cervical carcinoma in situ, breast cancer in situ or localized nonmelanoma skin cancer. - Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, or interfering with compliance for oral drug intake. - Concurrent treatment with experimental drugs or other anti-cancer therapy treatment in a clinical trial within 21 days prior to registration. - Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs or any concomitant drugs contraindicated. - Pregnant women - Nursing women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Explore the predictive ability of VeriStrat signature, by testing for interaction between treatment arms (Arm A: erlotinib vs Arm B: docetaxel) and VeriStrat status (Good vs Poor) using progression free survival as outcome.;Secondary Objective: - Explore whether treatment with erlotinib provides progression free survival (PFS) benefit compared to docetaxel in the VSG (VeriStrat Good) group. - Compare PFS in the two treatment arms (erlotinib vs docetaxel) in the VSP (VeriStrat Poor) group. - Explore the prognostic ability of VeriStrat signature by testing for an overall difference in PFS between the 2 VeriStrat groups. - Explore the predictive ability of the VeriStrat signature using the secondary measures of clinical efficacy including overall survival (OS), objective response rate, and disease control rate. - Compare OS, objective response rate and disease control rate between treatment groups separately in the VSG / VSP groups. - Explore the prognostic ability of the VeriStrat signature by testing for an overall difference in OS, objective response rate and disease control rate between the 2 VeriStrat groups. - Assess the safety and tolerability of the 2 treatments separately in each VeriStrat group and overall.;Primary end point(s): Progression free survival. Defined as the time from the date of randomization until documented progression or death without documented progression.;Timepoint(s) of evaluation of this end point: The final evaluation will be done within 6 months after the two-month visit of the last entered patient, approximately 26 months after the inclusion of the first patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Overall survival. Defined as time from the date of randomization until death from any cause. - Objective response. 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. Defined as achieving objective response or stable disease for at least 6 weeks. - Toxicities of treatment. Adverse events classified according to NCI CTCAE version 4.;Timepoint(s) of evaluation of this end point: The final evaluation will be done within 6 months after the two-month visit of the last entered patient, approximately 26 months after the inclusion of the first patient. | — |
Countries
Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Netherlands, Portugal, Spain, Switzerland, United Kingdom
Contacts
Public ContactETOP Coordinating Office
ETOP
Outcome results
None listed