Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®.
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib; Docetaxel
Intervention description: Erlotinib 150 mg/day p.o. continuously with 21 days cycle.; Docetaxel 75 mg/m2 as an IV infusion every 21 days.
Intervention MeSH terms: Docetaxel; Erlotinib Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: squamous cell; NSCLC; TKI; Erlotinib; Docetaxel; VeriStrat; protein signature

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.
    

Eligibility 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.

          -  Measurable or evaluable disease according to RECIST v1.1 (Appendix 2).

          -  ECOG PS 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 <1.5 x ULN; AP, ALT < 3.0 x ULN; AP, ALT <5 x ULN is acceptable in
             case of liver metastasis.

          -  Renal: calculated creatinine clearance > 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, during the trial and 12 months thereafter. Female patients with
             reproductive potential must have a negative pregnancy test within 7 days prior to
             study registration.

          -  Estimated life expectancy >12 weeks.

          -  Patient compliance and geographical proximity that allow adequate follow-up.

        Exclusion Criteria:

          -  Evidence of other medical condition 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 study registration.

          -  Documented presence of activating EGFR mutations, if the patient was tested for EGFR
             mutations.

          -  Previous malignancy within the past 5 years with the exception of adequately treated
             cervical carcinoma in situ, breast cancer in situ or localized non-melanoma 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 study registration.

          -  Known hypersensitivity to trial drugs or hypersensitivity to any other component of
             the trial drugs or any concomitant drugs contraindicated.