Erlotinib as 1st Line Treatment in NSCLC Stage IIIB/IV

Study Overview
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Brief Summary
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To evaluate the efficacy and toxicity of erlotinib as first line treatment in patients with locally advanced/metastatic (stages IIIB/IV) NSCLC, with clinical predictors of response to tyrosine kinase inhibitors (erlotinib, gefitinib), such as female gender, never-smoking status and adenocarcinoma histology. Furthermore, erlotinib-sensitivity will be correlated with the presence of EGFR mutations in exons 18, 19 and 21, in this population

Detailed Description
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A randomized, placebo-controlled phase III trial of erlotinib versus placebo, with more than 700 patients demonstrated that therapy with this tyrosine kinase inhibitor (TKI) prolongs survival after first or second line therapy in patients with advanced NSCLC. Statistically significant and clinically relevant differences were observed for overall and progression free survival in favour of erlotinib. Moreover, several clinical factors had been correlated with response to gefitinib or erlotinib, including never smoking status, female gender, Asian ethnicity and adenocarcinoma histology (especially bronchioalveolar carcinoma).

Official Title
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ERLOTINIB, A TYROSINE KINASE INHIBITOR OF EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) AS FIRST LINE TREATMENT, IN PATIENTS WITH LOCALLY ADVANCED/METASTATIC NON SMALL CELL LUNG CANCER (NSCLC). A PHASE II STUDY

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Erlotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC No previous therapy for advanced/metastatic NSCLC is allowed age >18 years bidimensionally measurable disease non-smokers (or ex-smokers with less than 5 pack-years smoking history) adenocarcinoma histology performance status (WHO) 0-3 adequate liver (serum bilirubin <1.5 times the upper normal limit (UNL); AST and ALT <2.5 times the UNL in the absence of demonstrable liver metastases, or <5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine <1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function previous radiotherapy, either in the adjuvant setting or for the treatment of metastatic disease is allowed provided that the measurable lesions are outside the radiation fields patient able to take oral medication tissue sample for tumour mutational analysis is required Exclusion Criteria: serious chronic skin conditions (e.g. psoriasis, eczema) that would preclude study participation active infection history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) malnutrition (loss of ≥ 20% of the original body weight) performance status: 4 psychiatric illness or social situation that would preclude study compliance pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Tarceva | Drug: Erlotinib<br>* Erlotinib at the dose of 150 mg orally once a day continually until progression<br>* Other names: Tarceva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate |  | Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 1-year OS | 
| Time to Tumor Progression |  | 1 year TTP | 
| Quality of life assessment |  | Assessment every two cycles | 
| Toxicity assesment |  | Toxicity assessment on each cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erlotinib, Biological therapy, Tyrosin Kinase Inhibitor therapy