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

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-Squamous Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT01519804

Run by

Genentech, Inc.

People needed

108

Starts

2012-04-01

Expected to finish

2015-09-01

Last updated by the study team

2016-09-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — Bakersfield, California, United States
• Study site — Fullerton, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Northridge, California, United States
• Study site — Sacramento, California, United States
• Study site — San Luis Obispo, California, United States
• Study site — Santa Barbara, California, United States
• Study site — Stanford, California, United States
• Study site — Grand Junction, Colorado, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Weston, Florida, United States
• Study site — Marietta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Harvey, Illinois, United States
• Study site — Fort Wayne, Indiana, United States
• Study site — Fort Wayne, Indiana, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Muncie, Indiana, United States
• Study site — Metairie, Louisiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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