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Complete title: A Randomized, Phase II, Multicenter, Double Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of MetMAb in Combination with either Bevacizumab + Platinum + Paclitaxel or Pemetrexed + Platinum as First-Line Treatment in Patients with Stage IIIB or IV Non Squamous Non-Small Cell Lung Cancer (NSCLC)
|Research Study Number||20111997|
|Principal Investigator||Keith Eaton, MD, PhD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
- Genders Eligible for Study: Both
- Adult patients, >/= 18 years of age
- Histologically or cytologically confirmed Stage IIIB or Stage IV non-squamous non-small cell lung cancer (NSCLC)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- For patients who received prior adjuvant chemotherapy: a treatment-free interval of at least 12 months since last chemotherapy cycle
- Adequate tissue for central IHC assay of Met receptor, and EGFR testing if EGFR status is unknown
- Radiographic evidence of disease
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Evidence of mixed NSCLC with a predominance of the squamous cell type
- Prior exposure to experimental treatment targeting either the HGF or Met pathway
- Patients with tumors confirmed to have EGFR-activating mutations who are suitable for anti-EGFR therapy (e.g. gefitinib or erlotinib), as determined by the investigator
- Known central nervous system (CNS) disease, other than stable, treated brain metastases
- History of another malignancy in the previous 3 years, except for history of in situ cancer or basal or squamous cell skin cancer
- Uncontrolled diabetes
- Pregnant or lactating women
- Impaired bone marrow, liver or renal function (as defined by protocol)
- Significant history of cardiovascular disease
- Positive for HIV infection
Other exclusion criteria may apply.
Lung Cancer; Solid Tumors
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