Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung

Study Overview
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Brief Summary
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The purpose of this trial is to figure out what effects (good or bad) the investigational drug agent called Tarceva (erlotinib; OSI-774) has on women with previously untreated adenocarcinoma.

Detailed Description
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Patients will start taking Tarceva daily by mouth on Day 1 and will continue taking this medication daily at home, until participation in the study ends.

Official Title
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A Phase II Study of Erlotinib (OSI-774); Tarceva in Women With Previously Untreated Advance Adenocarcinoma of the Lung

Conditions
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Adenocarcinoma, 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: Female Diagnosis of adenocarcinoma of the lung Patient has had at least one core biopsy of her tumor Must be willing to undergo epidermal growth factor receptor (EGFR) mutation testing of her tumor Stage four (IV) or three (III) B non-small cell lung cancer Non-smoker or former smoker. Non-smoker is defined as a person who smoked 100 or less cigarettes in her lifetime while a former smoker is defined as a person who has quit smoking one or more years ago. Three or more weeks since last radiation therapy Three or more weeks since last major surgery Must at least be able to walk and capable of taking care of herself although unable to carry out work activities Life expectancy of 8 weeks or more Blood tests that show kidneys, liver and bone marrow to be working adequately Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the entire time enrolled in study Exclusion Criteria: Prior exposure to Tarceva (OSI-774, erlotinib) Uncontrolled central nervous system problems Prior chemotherapy regimen Difficulty swallowing A disease or disorder that interferes with ability to digest and absorb food Incomplete healing of previous oncologic or other major surgery Significant medical history or unstable medical condition such as heart failure, active infection, uncontrolled high blood pressure Pregnant or breast feeding A medical condition that could make it unsafe for patient to participate in this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erlotinib<br>Erlotinib: 150 mg orally once daily without interruption Cycle duration considered 4 weeks and treatment duration indefinite until disease progression, unacceptable toxicity or withdrawal for other reasons. | Drug: Erlotinib<br> <br> * Other names: OSI-774;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | ORR is defined as the percentage of participants who achieve partial response (PR) or better on treatment based on RECIST 1.0 criteria: For target lesions, complete response (CR) is disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD (both require a minimum of 4 weeks). Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or appearance of one or more new target lesions. Stable disease (SD) is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions. | In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) by EGFR Mutation Status | ORR is defined as the percentage of participants who achieve partial response (PR) or better on treatment based on RECIST 1.0 criteria: For target lesions, complete response (CR) is disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD (both require a minimum of 4 weeks). Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or appearance of one or more new target lesions. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions. | In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. | 
| Overall Survival (OS) | OS is defined as the time from study entry to death or date last known alive. | In this study cohort, participants were followed for survival up to 155 months. | 
| Overall Survival by EGFR Mutation Status | OS is defined as the time from study entry to death or date last known alive. | In this study cohort, participants were followed for survival up to 155 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tarceva, Erlotinib, OSI-774, Adenocarcinoma, Advanced Lung Cancer