This is a Phase 2 study being conducted at multiple centers in the United States. Patients having non-small cell lung cancer that has spread to other parts of the body (i.e., metastatic) or is locally advanced (i.e., Stage IIIB with malignant pleural effusion) are eligible to participate. Patients must have disease that has been treated with no more than 1 prior treatment for metastatic disease (prior adjuvant treatment for localized disease does not count as prior treatment for metastatic disease). The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective treatment for advanced non-small cell lung cancer as shown by the number of patients in the study who experience significant and durable tumor shrinkage.

Condition	Treatment or Intervention	Phase
Non-Small-Cell Lung Carcinoma Metastases	Drug: AG-013736	Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Major entry criteria include the following:

• Histologically documented non-small cell cancer with metastases (Stage IV or recurrent) or locally advanced (Stage IIIB) with malignant pleural effusion
• No more than 1 prior systemic therapy for metastatic disease (prior adjuvant therapy for localized disease does not count as prior therapy for metastatic disease)
• At least 1 site of measurable disease that can be followed for response (i.e., at least 1 target lesion by Response Evaluation Criteria in Solid Tumors)
• At least 1 lesion that can be evaulated by dynamic contrast enhanced magnetic resonance imaging (DCE MRI)
• Adequate bone marrow, liver, and kidney function
• Must be able to swallow tablets
• No evidence of pre-existing, uncontrolled hypertension
• No lung lesions located centrally in the chest that involve major blood vessels
• No history of hemoptysis (coughing up of blood) that required medical intervention
• No brain metastases
• No prior treatment with anti-angiogenesis agents, including thalidomide or inhibitors or epidermal growth factor (EGF), platelet-derived growth factor (PDGF), or fibroblast growth factor (FGF) receptors

Call:      734-622-7600    ClinicalTrials.gov@Pfizer.com

Study ID Numbers:  A4061011
Record last reviewed:  October 2004
Record first received:  October 11, 2004
ClinicalTrials.gov Identifier:  NCT00094094
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-20