Non-small cell lung cancer (NSCLC), locally advanced (stage IIIB), metastatic (stage IV) or recurrent. MedDRA version: 9.1 Level: PT Classification code 10029521 MedDRA version: 9.1 Level: PT Classification code 10029522
Conditions
Interventions
Trade Name: Tarceva
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Erlotinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: Tarceva
Sponsors
ROCHE
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Written informed consent (the informed consent form must be approved by the independent Ethics Committee of the institute and approval must be obtained before any procedure related to the trial); 2. Males aged = 18 years; 3. Former smokers, that is individuals who have smoked at least 100 cigarettes in the course of their lives and given up more than 10 months before being enrolled in the trial; 4. Ability to comply with the procedures required by the protocol and follow up, as well as to take drugs orally; 5. Squamous locally advanced NSCLC (stage IIIB), metastatic (stage IV) or recurrent; 6. The measurable disease must be classified according to RECIST 1.1. criteria; 7. Subjects must have previously undergone platinum-based chemotherapy for advanced NSCLC, exhibit a progressive disease (PD) and all treatment-related toxicities must have been resolved; 8. Performance status between 0-1 on the ECOG (Eastern Cooperative Oncology Group) scale; 9. Life expectancy = 12 weeks; 10. Adequate haematologic function: - Absolute neutrophil count (ANC) = 1.5 x 10^9/l - Platelet count = 100 x 10^9/l - Haemoglobin = 9 g/dl (transfusions are permitted to maintain or exceed this level); 11. Adequate hepatic function: - Total bilirubin = 1.5 times the upper limit of normal (ULN) - Aspartate aminotransferase (AST), alanine aminotransferase (ALT) = 2.5 x ULN in subjects with no liver metastases; = 5 x ULN in patients with liver metastases - Alkaline phosphatase = 5 x ULN, with the exception of cases with osseous and liver metastases 12. Adequate renal function: - Serum creatinine = 1.25 x ULN. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Symptomatic metastases of the central nervous system (CNS) 2. Prior therapy aimed at the epidermal growth factor receptor (EGFR), with antibody or small molecule (e.g. tyrosine kinase inhibitor) 3. More than one line of chemotherapy for locally advanced/metastatic NSCLC. 4. Treatment with any other experimental drug or participation in another clinical trial within the 28 days preceding enrolment 5. History of melanoma at any time or history of another malignant neoplasia in the last 5 years, with the following exceptions: - Other malignant neoplasias cured with surgery alone and with a disease-free interval > 5 years - Basal cell cutaneous carcinoma which has been cured 6. Any unstable systemic disease (including an active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction in the previous year, serious cardiac arrhythmia requiring pharmacological treatment, hepatic, renal or metabolic disease) 7. HIV seropositivity. It is not necessary to carry out the test in the absence of clinical signs and symptoms indicating an HIV infection 8. Known hypersensitivity to erlotinib, docetaxel or any of its excipients; 9. An eye inflammation or infection which has not been fully treated or predisposing pathologies; 10. Evidence of any other disease, neurologic or metabolic dysfunction, physical examination or laboratory results that give rise to a reasonable suspicion of a disease or condition that represents a contraindication to the administration of an experimental drug or that puts the subject at great risk of complications related to treatment with HER1/EGFR inhibitors (such as therapy with monoclonal antibodies or small cells) or docetaxel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of erlotinib and erlotinib in combination with docetaxel in former smokers suffering from squamous NSCLC using as endpoint the percentage of Progression-Free Survival patients after 6 months.;Secondary Objective: 1. To evaluate PFS in both treatment arms 2. To evaluate overall survival (OS) in both treatment arms 3. To evaluate the objective response rate (ORR) and the duration of the response (DR) in both treatment arms 4. To map the expression of the principal cell proteins that regulate the biological processes activated by the EGFR (EGFR and K-ras mutation analysis ) in initial/pre-treatment tumour biopsy material (not mandatory for all patients) 5. To evaluate the tolerability and safety of each treatment arm of the trial 6. To evaluate the compliance to each treatment arm of the trial.;Primary end point(s): Percentage of Progression-Free Survival patients after 6 months. | — |
Countries
Italy
Outcome results
None listed