Erlotinib (Tarceva) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With EGFR Positive NSCLC

Study Overview
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Brief Summary
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This will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR overexpression and/or EGFR amplification.

Official Title
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A Phase 2 Randomized Study of Tarceva (Erlotinib) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With Newly Diagnosed Advanced Non-small Cell Lung Cancer Who Have Tumors With EGFR Protein Overexpression and/or Increased EGFR Gene Copy Numbers

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: Tarceva
* Drug: carboplatin
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >= 18 Histologically or cytologically documented non-small cell lung cancer (NSCLC) Eastern Cooperative Oncology Group (ECOG)performance status (PS)0, 1, 2 Radiologically measurable or evaluable disease No prior chemotherapy 1 or 2 epithelial growth factor receptor (EGFR) pathway markers positive at screening Tumor tissue block or fine needle aspirate Exclusion Criteria: Any concurrent anticancer therapy or radiation Other active malignancy Uncontrolled brain metastases GI abnormalities Severe abnormalities of the cornea Significant cardiac disease Active infection

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erlotinib<br>150 mg erlotinib daily | Drug: Tarceva<br>* oral tablet<br>* Other names: OSI-774;|
| Experimental: Erlotinib + chemotherapy (intercalated)<br>carboplatin AUC 6 on Day 1 to 21 days, paclitaxel 200 mg/m2 on Day 1 to 21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity | Drug: Tarceva<br>* oral tablet<br>* Other names: OSI-774;Drug: carboplatin<br>* IV<br>Drug: paclitaxel<br>* IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month Progression-free Survival | Percentage of patients who's disease had not progressed at 6 months. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression. | 6 months after first dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression. | Until time of disease progression, as assessed every 21 days (maximum 28.8 months) | 
| Overall Survival at 12 Months | Percentage of patients alive after 12 months of study treatment | 12 months from 1st dose | 
| Overall Survival | Median number of months from first study treatment until time of death | From first study treatment until time of death (maximum 29.0 months) | 
| Best Tumor Response | Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline | While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months) | 
| Duration of Tumor Response | Median length of time that tumor showed any type of response, ie, CR, PR, or SD | While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, Erlotinib, Tarceva, Lung Cancer