A Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Metastatic or Recurrent Non-Small Cell Cancer Who Present Epidermal Growth Factor Receptor Mutations

Study Overview
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Brief Summary
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This open-label study will assess the efficacy and safety of Tarceva (Erlotinib) in patients with locally advanced, metastatic or recurrent non-small cell lung cancer who have not received previous chemotherapy for their disease and who present epidermal growth factor receptor mutations. Patients will receive Tarceva 150 mg orally daily until disease progression or unacceptable toxicity occurs.

Official Title
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Phase II, Open-label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced, Metastatic or Recurrent Non-small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor

Conditions
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Non-Squamous Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: erlotinib [Tarceva]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, >/= 18 years of age Locally advanced (Stage IIIB), metastatic (Stage IV) or recurrent non-small cell lung cancer with mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR) At least one measurable lesion according to RECIST criteria European Cooperative Oncology Group (ECOG) performance status 0-2 Adequate hematological, liver and renal function Patients with stable cerebral metastases who have received surgical or radiotherapy will be eligible Exclusion Criteria: Previous chemotherapy or therapy against EGFR for metastatic disease (neoadjuvant or adjuvant therapy after radical surgery is allowed if finalized >/= 6 months before entering the study) History of another neoplasm except for carcinoma in situ of the cervix, adequately treated basal cell skin carcinoma, radically treated prostate carcinoma with good prognosis (Gleason </= 6), or another curatively treated neoplasm without evidence of disease in the last 5 years Symptomatic cerebral metastases Any significant ophthalmologic abnormality Use of coumarins Pregnant or breast-feeding women Pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis and carcinomatosis (if this is the only presence of the 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Drug: erlotinib [Tarceva]<br>* 150 mg orally daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (Tumour Assessments According to RECIST Criteria) | Progression free survival is (PFS) defined as the time from the first dose of Erlotinib to the date of first occurrence of disease progression or death. | Until participants had disease progression, unacceptable toxicity or died; approximately 24 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (Investigator Assessed) | Objective response rate (ORR) was defined by RECIST criteria: Partial response (PR) was defined as ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) was defined as disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression of disease (PD) = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions. Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on the study. | Visit 4, Visit 6, Visit 10 and Visit 22; (up to approximately 24 months) | 
| Safety: Incidence of Adverse Events | An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An SAE is any experience that suggests a significant hazard, contraindication, side effect, or precaution. | Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months. | 
| Overall Survival | The overall survival (OS) is defined as the time from the first dose of Erlotinib to the date of death due to any cause. | Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months. |