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 Disease) or IV Squamous Non-Small Cell Lung Cancer (NSCLC)
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.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : onartuzumab
- drug : cisplatin/carboplatin
- drug : paclitaxel
- drug : Placebo
Phase: Phase 2
Ages Eligible For Study:
- 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