Trial Search Results

A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer

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 currently not accepting patients for this trial.

Lead Sponsor:

Genentech, Inc.


  • Drug: Placebo
  • Drug: cisplatin/carboplatin
  • Drug: onartuzumab
  • Drug: paclitaxel


Phase 2


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
Not Recruiting