A randomized phase III trial of erlotinib versus docetaxel in patients withadvanced lungcancer of the type non-small cell lung cancerwho failed first linecombination chemotherapy treatment, stratified into forecast group good or bad by the test VeriStrat

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

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 <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, 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

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method