Trial record 1 of 1 for:    GO27820
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A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01519804
Recruitment Status : Completed
First Posted : January 27, 2012
Last Update Posted : September 2, 2016
Information provided by (Responsible Party):
Genentech, Inc.

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.

Condition or disease Intervention/treatment Phase
Non-Squamous Non-Small Cell Lung Cancer Drug: Placebo Drug: cisplatin/carboplatin Drug: onartuzumab Drug: paclitaxel Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : April 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: MetMAb+paclitaxel+platinum Drug: cisplatin/carboplatin
standard dose iv, Day 1 of each 21-day cycle, 4 cycles

Drug: onartuzumab
15 mg/kg iv, Day 1 of each 21-day cycle
Other Name: MetMAb

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

Active Comparator: Placebo+paclitaxel+platinum Drug: Placebo
Matching onartuzumab (MetMAb) placebo iv, Day 1 of each 21-day cycle

Drug: cisplatin/carboplatin
standard dose iv, Day 1 of each 21-day cycle, 4 cycles

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

Primary Outcome Measures :
  1. Progression-free survival (tumor assessments according to RECIST criteria) [ Time Frame: up to approximately 32 months ]
  2. Progression-free survival: Subgroup of patients with Met diagnostic-positive squamous NSCLC [ Time Frame: up to approximately 32 months ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: up to approximately 32 months ]
  2. Overall response rate (tumor assessments according to RECIST criteria) [ Time Frame: up to approximately 32 months ]
  3. Duration of response (time from first documented objective response to disease progression) [ Time Frame: up to approximately 32 months ]
  4. Disease control rate (rate of partial response plus complete response plus stable disease for at least 6 weeks) [ Time Frame: up to approximately 32 months ]
  5. Safety: Incidence of adverse events [ Time Frame: up to approximately 32 months ]
  6. Pharmacokinetics: serum concentration (Cmin/Cmax) [ Time Frame: Pre- and post-dose on Day 1 of Cycles 1, 2 and 4 and up to 2 years ]
  7. Plasma concentrations of paclitaxel/platinum [ Time Frame: Pre- and post-dose on Day 1 of Cycles 1 and 4 ]
  8. Serum levels of anti-therapeutic antibodies (MetMAb ATAs) [ Time Frame: Pre-dose Day 1 of Cycles 1, 2 and 4 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01519804

  Hide Study Locations
United States, Alabama
Huntsville, Alabama, United States, 35805
United States, Arizona
Scottsdale, Arizona, United States, 85259
United States, California
Bakersfield, California, United States, 93309
Fullerton, California, United States, 92835
Los Angeles, California, United States, 90024
Los Angeles, California, United States, 90095-1772
Northridge, California, United States, 91328
Sacramento, California, United States, 95817
San Luis Obispo, California, United States, 93454
Santa Barbara, California, United States, 93105
Stanford, California, United States, 94305
United States, Colorado
Grand Junction, Colorado, United States, 81502-1628
United States, Florida
Boynton Beach, Florida, United States, 33435
Orlando, Florida, United States, 32804
Weston, Florida, United States, 33331
United States, Georgia
Marietta, Georgia, United States, 30060
United States, Illinois
Chicago, Illinois, United States, 60611
Harvey, Illinois, United States, 60426
United States, Indiana
Fort Wayne, Indiana, United States, 46815
Fort Wayne, Indiana, United States, 46845
Indianapolis, Indiana, United States, 46260
Muncie, Indiana, United States, 47303
United States, Louisiana
Metairie, Louisiana, United States, 70006
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02215
United States, Minnesota
Minneapolis, Minnesota, United States, 55454
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, Nevada
Las Vegas, Nevada, United States, 89148
United States, North Carolina
Hickory, North Carolina, United States, 28602
United States, Ohio
Cleveland, Ohio, United States, 44195
Middletown, Ohio, United States, 45042
United States, Oregon
Bend, Oregon, United States, 97701
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15232
United States, Washington
Seattle, Washington, United States, 98195
Buenos Aires, Argentina, C1426ANZ
La Rioja, Argentina, F5300COE
Santa Rosa, Argentina, L6304BOC
Grenoble, France, 38043
Lyon, France, 69373
Paris, France, 75674
Rennes, France, 35033
Berlin, Germany, 12203
Göttingen, Germany, 37075
Halle (Saale), Germany, 06120
Immenhausen, Germany, 34376
München, Germany, 81925
Münster, Germany, 48149
Afula, Israel, 18101
Ashkelon, Israel, 78278
Tel Aviv, Israel, 6423906
Zerifin, Israel, 6093000
Avellino, Campania, Italy, 83100
Napoli, Campania, Italy, 80131
Udine, Friuli-Venezia Giulia, Italy, 33100
Cremona, Lombardia, Italy, 26100
Milano, Lombardia, Italy, 20133
Daugavpils, Latvia, 5417
Liepaja, Latvia, LV 3401
Riga, Latvia, LV 1079
Riga, Latvia, LV-1002
Pamplona, Navarra, Spain, 31008
Barcelona, Spain, 08036
Madrid, Spain, 28007
Madrid, Spain, 28050
Zaragoza, Spain, 50009
United Kingdom
Aberdeen, United Kingdom, AB25 2ZN
Birmingham, United Kingdom, B9 5SS
Bournemouth, United Kingdom, BH7 7DW
Leeds, United Kingdom, LS9 7TF
Sponsors and Collaborators
Genentech, Inc.
Study Director: Clinical Trials Genentech, Inc.

Responsible Party: Genentech, Inc. Identifier: NCT01519804     History of Changes
Other Study ID Numbers: GO27820
First Posted: January 27, 2012    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Albumin-Bound Paclitaxel
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs