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

This study is currently recruiting participants.
Verified April 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01519804
First received: December 19, 2011
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Non-Small Cell Lung Cancer
Drug: onartuzumab
Drug: Placebo
Drug: paclitaxel
Drug: cisplatin/carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Progression-free survival (tumor assessments according to RECIST criteria) [ Time Frame: up to approximately 32 months ] [ Designated as safety issue: No ]
  • Progression-free survival: Subgroup of patients with Met diagnostic-positive squamous NSCLC [ Time Frame: up to approximately 32 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: up to approximately 32 months ] [ Designated as safety issue: No ]
  • Overall response rate (tumor assessments according to RECIST criteria) [ Time Frame: up to approximately 32 months ] [ Designated as safety issue: No ]
  • Duration of response (time from first documented objective response to disease progression) [ Time Frame: up to approximately 32 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to approximately 32 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Plasma concentrations of paclitaxel/platinum [ Time Frame: Pre- and post-dose on Day 1 of Cycles 1 and 4 ] [ Designated as safety issue: No ]
  • Serum levels of anti-therapeutic antibodies (MetMAb ATAs) [ Time Frame: Pre-dose Day 1 of Cycles 1, 2 and 4 ] [ Designated as safety issue: No ]

Estimated Enrollment: 109
Study Start Date: April 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MetMAb+paclitaxel+platinum Drug: onartuzumab
15 mg/kg iv, Day 1 of each 21-day cycle
Drug: paclitaxel
200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles
Drug: cisplatin/carboplatin
standard dose 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: paclitaxel
200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles
Drug: cisplatin/carboplatin
standard dose iv, Day 1 of each 21-day cycle, 4 cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519804

Contacts
Contact: Reference Study ID Number: GO27820 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
United States, Alabama
Active, not recruiting
Huntsville, Alabama, United States, 35805
United States, Arizona
Completed
Scottsdale, Arizona, United States, 85259
United States, California
Active, not recruiting
Bakersfield, California, United States, 93309
Completed
Fullerton, California, United States, 92835
Active, not recruiting
Los Angeles, California, United States, 90095-1772
Completed
Los Angeles, California, United States, 90024
Completed
Northridge, California, United States, 91325
Completed
Sacramento, California, United States, 95817
Completed
San Luis Obispo, California, United States, 93454
Terminated
Santa Barbara, California, United States, 93105
Active, not recruiting
Stanford, California, United States, 94305
United States, Colorado
Completed
Grand Junction, Colorado, United States, 81502-1628
United States, Florida
Completed
Boynton Beach, Florida, United States, 33435
Completed
Orlando, Florida, United States, 32804
Terminated
Weston, Florida, United States, 33331
United States, Georgia
Active, not recruiting
Marietta, Georgia, United States, 30060
United States, Illinois
Active, not recruiting
Chicago, Illinois, United States, 60611
Terminated
Harvey, Illinois, United States, 60426
United States, Indiana
Terminated
Fort Wayne, Indiana, United States, 46845
Terminated
Fort Wayne, Indiana, United States, 46815
Active, not recruiting
Indianapolis, Indiana, United States, 46260
Terminated
Muncie, Indiana, United States, 47303
United States, Louisiana
Active, not recruiting
Metairie, Louisiana, United States, 70006
United States, Massachusetts
Completed
Boston, Massachusetts, United States, 02114
Active, not recruiting
Boston, Massachusetts, United States, 02215
United States, Minnesota
Active, not recruiting
Minneapolis, Minnesota, United States, 55454
United States, Missouri
Active, not recruiting
St. Louis, Missouri, United States, 63110
United States, Nevada
Completed
Las Vegas, Nevada, United States, 89148
United States, North Carolina
Completed
Hickory, North Carolina, United States, 28602
United States, Ohio
Active, not recruiting
Cleveland, Ohio, United States, 44195
Terminated
Middletown, Ohio, United States, 45042
United States, Oregon
Completed
Bend, Oregon, United States, 97701
United States, Pennsylvania
Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Washington
Terminated
Seattle, Washington, United States, 98195
Argentina
Completed
Buenos Aires, Argentina, C1426ANZ
Recruiting
La Rioja, Argentina, F5300COE
Completed
Santa Rosa, Argentina, L6304BOC
France
Active, not recruiting
Grenoble, France, 38043
Terminated
Lyon, France, 69373
Terminated
Paris, France, 75674
Terminated
Rennes, France, 35033
Germany
Recruiting
Berlin, Germany, 12203
Terminated
Göttingen, Germany, 37075
Active, not recruiting
Halle (Saale), Germany, 06120
Active, not recruiting
Immenhausen, Germany, 34376
Active, not recruiting
München, Germany, 81925
Completed
Münster, Germany, 48149
Israel
Active, not recruiting
Afula, Israel, 18101
Completed
Ashkelon, Israel, 78278
Active, not recruiting
Tel Aviv, Israel, 6423906
Terminated
Zerifin, Israel, 70300
Italy
Terminated
Avellino, Campania, Italy, 83100
Completed
Napoli, Campania, Italy, 80131
Completed
Udine, Friuli-Venezia Giulia, Italy, 33100
Active, not recruiting
Cremona, Lombardia, Italy, 26100
Completed
Milano, Lombardia, Italy, 20133
Latvia
Completed
Daugavpils, Latvia, 5417
Completed
Liepaja, Latvia, LV 3401
Terminated
Riga, Latvia, LV-1002
Active, not recruiting
Riga, Latvia, LV 1079
Spain
Terminated
Pamplona, Navarra, Spain, 31008
Terminated
Barcelona, Spain, 08036
Active, not recruiting
Madrid, Spain, 28050
Completed
Madrid, Spain, 28041
Active, not recruiting
Zaragoza, Spain, 50009
United Kingdom
Completed
Aberdeen, United Kingdom, AB9 2ZB
Active, not recruiting
Birmingham, United Kingdom, B9 5SS
Terminated
Bournemouth, United Kingdom, BH7 7DW
Terminated
Leeds, United Kingdom, LS9 7TF
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01519804     History of Changes
Other Study ID Numbers: GO27820
Study First Received: December 19, 2011
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Cisplatin
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 16, 2014