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Complete title: Randomized, Phase II, Multicenter, Double-Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of MetMAb in Combination with Paclitaxel + Cisplatin or Carboplatin as First-Line Treatment for Patients with Stage IIIB (T4 Disease) or IV Squamous NonSmall Cell Lung Cancer (NSCLC)
|Research Study Number||20111995|
|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 III B or Stage IV squamous non-small cell lung cancer (NSCLC)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- No prior chemotherapy for squamous NSCLC
- 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)
- NSCLC with histology classified as adenocarcinoma, large cell, mixed adenosquamous, or NSCLC not otherwise specified (NOS)
- 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
- Uncontrolled brain metastases and treatment by neurosurgical resection or brain biopsy within 4 weeks prior to Day 1 of Cycle 1
- History of another malignancy in the previous 3 years except for prior history of in situ cancer or basal or squamous cell skin cancer
- Pregnant or lactating women
- Uncontrolled diabetes
- 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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