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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
Not Recruiting
Trial ID: NCT01496742
Purpose
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.
Official Title
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
Stanford Investigator(s)
Kavitha Ramchandran
Clinical Professor, Medicine - Oncology
Heather Wakelee
Professor of Medicine (Oncology)
Joel Neal, MD, PhD
Associate Professor of Medicine (Oncology)
Eligibility
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
Intervention(s):
drug: RO5490258
drug: bevacizumab [Avastin]
drug: pemetrexed
drug: Placebo
drug: cisplatin/carboplatin
drug: paclitaxel
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061