A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab (Avastin) Plus Platinum And Paclitaxel or With Pemetrexed Plus Platinum in Patients With Non-Squamous Non-Small Cell Lung Cancer

Status:	Completed
Conditions:	Lung Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	8/10/2016
Start Date:	April 2012
End Date:	November 2015

A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Metmab Vs. Placebo in Combination With Either Bevacizumab + Platinum + Paclitaxel or Pemetrexed + Platinum in Patients With Untreated Stage IIIb or IV Non-Squamous NSCLC

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the
efficacy and safety of RO5490258 (MetMab) in combination with either of two backbone
chemotherapy regimens in the first-line setting in patients with incurable Stage IIIB or IV
non-squamous non-small cell lung cancer. In Cohort 1, patients will be randomized to receive
4 cycles of bevacizumab (Avastin) 15 mg/kg iv, paclitaxel 200 mg/m2 iv, platinum
(cisplatin/carboplatin) iv plus either MetMab 15 mg/kg iv or placebo on Day 1 of each 21-day
cycle. In Cohort 2, patients will be randomized to receive pemetrexed 500 mg/m2 iv, platinum
(cisplatin/carboplatin) iv plus either MetMAb 15 mg/m2 iv or placebo on Day 1 of each 21-day
cycle. Patients who have not progressed after 4 cycles will be offered maintenance therapy
with their assigned treatment of bevacizumab plus either MetMAb or placebo (Cohort 1) or
pemetrexed plus either MetMAb or placebo (Cohort 2). Anticipated time on study treatment is
until disease progression or unacceptable toxicity occurs.

Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Histologically or cytologically confirmed Stage IIIB or Stage IV non-squamous
non-small cell lung cancer (NSCLC)

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- For patients who received prior adjuvant chemotherapy or chemoradiotherapy: a
treatment-free interval of at least 12 months since last chemotherapy or
chemoradiotherapy cycle

- Adequate tissue for central immunohistochemical (IHC) assay of Met receptor, and
epidermal growth factor receptor (EGFR) testing if EGFR status is unknown

- Radiographic evidence of disease

Exclusion Criteria:

- Prior systemic treatment for Stage IIIB or IV non-squamous NSCLC

- Evidence of mixed NSCLC with a predominance of the squamous cell type

- Prior exposure to experimental treatment targeting either the hepatocyte growth
factor (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,
unless that treatment is unavailable or refused by the patient

- Known central nervous system (CNS) disease, other than stable, treated brain
metastases

- History of another malignancy in the previous 3 years, except for history of in situ
cancer that was treated surgically with curative intent, localized prostate cancer
that has been treated surgically with curative intent, or basal or squamous cell skin
cancer

- Uncontrolled diabetes

- Pregnant or lactating women

- 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 Indianapolis Indiana

Indianapolis, Indiana 46202

from

Indianapolis, IN