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

Status:	Completed
Conditions:	Lung Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	6/3/2016
Start Date:	April 2012
End Date:	September 2015

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.

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

We found this trial at

sites

Clinical Trial Facility in Huntsville Alabama

Huntsville, Alabama 35801

660

from

Huntsville, AL