Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2

Study Overview
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Brief Summary
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The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. The study will also evaluate the safety of single-agent erlotinib in this patient population.

Official Title
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A Randomized Phase II Study of Single Agent Erlotinib [Tarceva (TM), OSI-774] Versus Standard Chemotherapy in Patients With Previously Untreated Advanced NSCLC and a Poor Performance Status

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)
* Drug: Combination carboplatin and paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage IIIB or IV Nonsmall cell lung cancer (NSCLC) No prior chemotherapy Eastern Cooperative Oncology Group (ECOG) Performance Status 2 Clinically or radiologically measurable disease per RECIST criteria Exclusion Criteria: Gastro-intestinal abnormalities Any concurrent anticancer therapy Prior treatment with epidermal growth factor receptor (EGFR) inhibitors of any kind Other active malignancies Uncontrolled brain metastases Severe abnormalities of the cornea Significant cardiac disease

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>Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy | Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)<br>* Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy<br>|
| Active Comparator: Standard Chemotherapy<br>Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles | Drug: Combination carboplatin and paclitaxel<br>* Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles<br>|

What is the study measuring?
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Primary 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 (maximum 5 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Median number of months from first study treatment until time of death | From first study treatment until time of death (maximum 26.8 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 20% larger than at baseline. | While receiving study treatment (maximum 60 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tarceva, NSCLC, EGFR, ECOG Performance Status 2, erlotinib, Non-Small Cell Lung Cancer, OSI-774