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

NCT01519804 | Completed Phase 2

• 1 other identifier: GO27820
• Study Type: interventional
• Target: 108
• Locations: 9 countries
• Sites: 69

Brief Summary

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.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Progression-free survival (tumor assessments according to RECIST criteria)

  up to approximately 32 months

• Progression-free survival: Subgroup of patients with Met diagnostic-positive squamous NSCLC

  up to approximately 32 months

Secondary Outcomes (8)

• Overall survival

  up to approximately 32 months

• Overall response rate (tumor assessments according to RECIST criteria)

  up to approximately 32 months

• Duration of response (time from first documented objective response to disease progression)

  up to approximately 32 months

• Disease control rate (rate of partial response plus complete response plus stable disease for at least 6 weeks)

  up to approximately 32 months

• Safety: Incidence of adverse events

  up to approximately 32 months

Study Arms (2)

MetMAb+paclitaxel+platinum

EXPERIMENTAL

Drug: cisplatin/carboplatin; Drug: onartuzumab; Drug: paclitaxel

Placebo+paclitaxel+platinum

ACTIVE COMPARATOR

Drug: Placebo; Drug: cisplatin/carboplatin; Drug: paclitaxel

Interventions

Placebo DRUG

Matching onartuzumab (MetMAb) placebo iv, Day 1 of each 21-day cycle

Placebo+paclitaxel+platinum

cisplatin/carboplatin DRUG

standard dose iv, Day 1 of each 21-day cycle, 4 cycles

MetMAb+paclitaxel+platinum; Placebo+paclitaxel+platinum

onartuzumab DRUG

15 mg/kg iv, Day 1 of each 21-day cycle

Also known as: MetMAb

MetMAb+paclitaxel+platinum

paclitaxel DRUG

200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles

MetMAb+paclitaxel+platinum; Placebo+paclitaxel+platinum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (69)

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Huntsville, Alabama, 35805, United States

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Scottsdale, Arizona, 85259, United States

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Bakersfield, California, 93309, United States

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Fullerton, California, 92835, United States

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Los Angeles, California, 90024, United States

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Los Angeles, California, 90095-1772, United States

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Northridge, California, 91328, United States

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Sacramento, California, 95817, United States

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San Luis Obispo, California, 93454, United States

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Santa Barbara, California, 93105, United States

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Stanford, California, 94305, United States

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Grand Junction, Colorado, 81502-1628, United States

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Boynton Beach, Florida, 33435, United States

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Orlando, Florida, 32804, United States

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Weston, Florida, 33331, United States

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Marietta, Georgia, 30060, United States

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Chicago, Illinois, 60611, United States

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Harvey, Illinois, 60426, United States

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Fort Wayne, Indiana, 46815, United States

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Fort Wayne, Indiana, 46845, United States

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Indianapolis, Indiana, 46260, United States

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Muncie, Indiana, 47303, United States

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Metairie, Louisiana, 70006, United States

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Boston, Massachusetts, 02114, United States

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Boston, Massachusetts, 02215, United States

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Minneapolis, Minnesota, 55454, United States

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St Louis, Missouri, 63110, United States

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Las Vegas, Nevada, 89148, United States

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Hickory, North Carolina, 28602, United States

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Cleveland, Ohio, 44195, United States

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Middletown, Ohio, 45042, United States

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Bend, Oregon, 97701, United States

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Pittsburgh, Pennsylvania, 15232, United States

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Seattle, Washington, 98195, United States

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Buenos Aires, C1426ANZ, Argentina

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La Rioja, F5300COE, Argentina

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Santa Rosa, L6304BOC, Argentina

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Grenoble, 38043, France

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Lyon, 69373, France

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Paris, 75674, France

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Rennes, 35033, France

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Berlin, 12203, Germany

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Göttingen, 37075, Germany

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Halle, 06120, Germany

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Immenhausen, 34376, Germany

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München, 81925, Germany

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Münster, 48149, Germany

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Afula, 18101, Israel

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Ashkelon, 78278, Israel

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Tel Aviv, 6423906, Israel

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Ẕerifin, 6093000, Israel

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Avellino, Campania, 83100, Italy

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Napoli, Campania, 80131, Italy

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Udine, Friuli Venezia Giulia, 33100, Italy

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Cremona, Lombardy, 26100, Italy

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Milan, Lombardy, 20133, Italy

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Daugavpils, 5417, Latvia

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Liepāja, LV 3401, Latvia

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Riga, LV 1079, Latvia

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Riga, LV-1002, Latvia

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Barcelona, Barcelona, 08036, Spain

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Madrid, Madrid, 28007, Spain

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Madrid, Madrid, 28050, Spain

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Pamplona, Navarre, 31008, Spain

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Zaragoza, Zaragoza, 50009, Spain

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Aberdeen, AB25 2ZN, United Kingdom

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Birmingham, B9 5SS, United Kingdom

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Bournemouth, BH7 7DW, United Kingdom

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Leeds, LS9 7TF, United Kingdom

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MeSH Terms

Interventions

Cisplatin; Carboplatin; onartuzumab; Paclitaxel

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2011
• First Posted: January 27, 2012
• Study Start: April 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: September 1, 2015
• Last Updated: September 2, 2016

Record last verified: 2016-09

Locations

US (34); DE (6); GB (4); IL (4); LA (4); ES (5); AR (3); FR (4); IT (5)