View Clinical Trial (Medical Research Study)

A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (Metmab) in Combination With Paclitaxel + Cisplatin or Carboplatin as First-Line Treatment for Patients With Stage IIIb (T4 Disea

---

Conditions:		Non-Small Cell Lung Cancer
Purpose:		This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC). Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as maintenance therapy until disease progression or unacceptable toxicity occurs.
Study Summary:
Criteria:		Inclusion Criteria: - 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 Exclusion Criteria: - Prior systemic treatment for Stage IIIB or IV squamous NSCLC - 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
NCT ID:		NCT01519804
Primary Contact:		Study Director Clinical Trials Genentech Please reference Study ID Number: GO27820 www.roche.com/about_roche/roche_worldwide.htm Phone: 888-662-6728 (U.S. Only) Email: genentechclinicaltrials@druginfo.com
Backup Contact:		N/A
Location Contact:		Huntsville, Alabama 35805 United States There is no listed contact information for this specific location. Site Status: Not yet recruiting

---

---