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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01519804
First received: December 19, 2011
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

This multicenter, randomized, double-blind, placebo-controlled study will evalua te the efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxe l plus platinum in patients with incurable Stage IIIB or Stage IV squamous non-s mall cell lung cancer (NSCLC). Patients will be randomized to receive either ona rtuzumab (MetMAb) 15 mg/kg iv or placebo on Day 1 of each 21-day cycle in combin ation with 4 cycles of paclitaxel 200 mg/m2 iv and platinum (carboplatin/cisplat in) iv on Day 1 of each 21-day cycle. Patients who have not progressed after 4 c ycles will continue with either onartuzumab (MetMAb) or placebo as maintenance t herapy until disease progression or unacceptable toxicity occurs.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Placebo
Drug: cisplatin/carboplatin
Drug: onartuzumab
Drug: paclitaxel
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, Inc.:

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 ]

Enrollment: 108
Study Start Date: April 2012
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
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, 90095-1772
Los Angeles, California, United States, 90024
Northridge, California, United States, 91325
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, 46845
Fort Wayne, Indiana, United States, 46815
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, 02215
Boston, Massachusetts, United States, 02114
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
Argentina
Buenos Aires, Argentina, C1426ANZ
La Rioja, Argentina, F5300COE
Santa Rosa, Argentina, L6304BOC
France
Grenoble, France, 38043
Lyon, France, 69373
Paris, France, 75674
Rennes, France, 35033
Germany
Berlin, Germany, 12203
Göttingen, Germany, 37075
Halle (Saale), Germany, 06120
Immenhausen, Germany, 34376
München, Germany, 81925
Münster, Germany, 48149
Israel
Afula, Israel, 18101
Ashkelon, Israel, 78278
Tel Aviv, Israel, 6423906
Zerifin, Israel, 6093000
Italy
Avellino, Campania, Italy, 83100
Napoli, Campania, Italy, 80131
Udine, Friuli-Venezia Giulia, Italy, 33100
Cremona, Lombardia, Italy, 26100
Milano, Lombardia, Italy, 20133
Latvia
Daugavpils, Latvia, 5417
Liepaja, Latvia, LV 3401
Riga, Latvia, LV-1002
Riga, Latvia, LV 1079
Spain
Pamplona, Navarra, Spain, 31008
Barcelona, Spain, 08036
Madrid, Spain, 28050
Madrid, Spain, 28007
Zaragoza, Spain, 50009
United Kingdom
Aberdeen, United Kingdom, AB9 2ZB
Birmingham, United Kingdom, B9 5SS
Bournemouth, United Kingdom, BH7 7DW
Leeds, United Kingdom, LS9 7TF
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

No publications provided

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

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

ClinicalTrials.gov processed this record on October 21, 2014