A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab (Avastin) Plus Platinum And Paclitaxel or With Pemetrexed Plus Platinum in Patients With Non-Squamous Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified December 2012 by Genentech
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01496742
First received: December 19, 2011
Last updated: December 5, 2012
Last verified: December 2012
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Purpose
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RO5490258 (MetMab) in combination with either of two backbone chemotherapy regimens in the first-line setting in patients with incurable Stage IIIB or IV non-squamous non-small cell lung cancer. In Cohort 1, patients will be randomized to receive 4 cycles of bevacizumab (Avastin) 15 mg/kg iv, paclitaxel 200 mg/m2 iv, platinum (cisplatin/carboplatin) iv plus either MetMab 15 mg/kg iv or placebo on Day 1 of each 21-day cycle. In Cohort 2, patients will be randomized to receive pemetrexed 500 mg/m2 iv, platinum (cisplatin/carboplatin) iv plus either MetMAb 15 mg/m2 iv or placebo on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will be offered maintenance therapy with their assigned treatment of bevacizumab plus either MetMAb or placebo (Cohort 1) or pemetrexed plus either MetMAb or placebo (Cohort 2). Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Drug: RO5490258 Drug: bevacizumab [Avastin] Drug: pemetrexed Drug: Placebo Drug: cisplatin/carboplatin 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 Metmab Vs. Placebo in Combination With Either Bevacizumab + Platinum + Paclitaxel or Pemetrexed + Platinum in Patients With Untreated Stage IIIb or IV Non-Squamous NSCLC |
Resource links provided by NLM:
Drug Information available for:
Cisplatin
Paclitaxel
Carboplatin
Pemetrexed
Pemetrexed disodium
Bevacizumab
U.S. FDA Resources
Further study details as provided by Genentech:
Primary Outcome Measures:
- Progression-free survival (tumor assessments according to RECIST criteria) [ Time Frame: up to approximately 23 months ] [ Designated as safety issue: No ]
- Progression-free survival: Subgroup of patients with Met diagnostic positive tumors [ Time Frame: up to approximately 23 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Time Frame: up to approximately 23 months ] [ Designated as safety issue: No ]
- Overall response rate (tumor assessments according to RECIST criteria) [ Time Frame: up to approximately 23 months ] [ Designated as safety issue: No ]
- Duration of response (time from first documented objective response to disease progression) [ Time Frame: up to approximately 23 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 23 months ] [ Designated as safety issue: No ]
- Safety: Incidence of adverse events [ Time Frame: up to approximately 23 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 at study termination ] [ Designated as safety issue: No ]
- Serum concentrations of bevacizumab/paclitaxel/pemetrexed/platinum in combination with MetMAb [ 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: | 260 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Bevacizumab+MetMAb |
Drug: RO5490258
15 mg/kg iv, Day 1 of each 21-day cycle
Other Name: MetMAb
Drug: bevacizumab [Avastin]
15 mg/kg 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
|
| Active Comparator: Bevacizumab+Placebo |
Drug: bevacizumab [Avastin]
15 mg/kg iv, Day 1 of each 21-day cycle
Drug: Placebo
Matching RO5490258 (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
|
| Experimental: Pemetrexed+MetMAb |
Drug: RO5490258
15 mg/kg iv, Day 1 of each 21-day cycle
Other Name: MetMAb
Drug: pemetrexed
500 mg/m2, Day 1 of each 21-day cycle
Drug: cisplatin/carboplatin
standard dose iv, Day 1 of each 21-day cycle, 4 cycles
|
| Active Comparator: Pemetrexed+Placebo |
Drug: pemetrexed
500 mg/m2, Day 1 of each 21-day cycle
Drug: Placebo
Matching RO5490258 (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
|
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 IIIB or Stage IV non-squamous non-small cell lung cancer (NSCLC)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- For patients who received prior adjuvant chemotherapy: a treatment-free interval of at least 12 months since last chemotherapy cycle
- 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 non-squamous NSCLC
- Evidence of mixed NSCLC with a predominance of the squamous cell type
- 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
- Known central nervous system (CNS) disease, other than stable, treated brain metastases
- History of another malignancy in the previous 3 years, except for history of in situ cancer or basal or squamous cell skin cancer
- Uncontrolled diabetes
- Pregnant or lactating women
- 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: NCT01496742
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Contacts
| Contact: Please reference Study ID Number: GO27821 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Hide Study LocationsLocations
| United States, Alabama | |
| Recruiting | |
| Huntsville, Alabama, United States, 35805 | |
| United States, Arizona | |
| Recruiting | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, California | |
| Not yet recruiting | |
| Alhambra, California, United States, 91801 | |
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| Bakersfield, California, United States, 93309 | |
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| Fullerton, California, United States, 92835 | |
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| Los Angeles, California, United States, 90024 | |
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| Northridge, California, United States, 91325 | |
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| Redondo Beach, California, United States, 90277 | |
| Terminated | |
| Santa Barbara, California, United States, 93105 | |
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| Santa Barbara, California, United States, 93105 | |
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| Santa Maria, California, United States, 93454 | |
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| Stanford, California, United States, 94305-5820 | |
| United States, Colorado | |
| Not yet recruiting | |
| Aurora, Colorado, United States, 80045 | |
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| Grand Junction, Colorado, United States, 81502-1628 | |
| United States, Florida | |
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| Boynton Beach, Florida, United States, 33435 | |
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| Hollywood, Florida, United States, 33021 | |
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| Orlando, Florida, United States, 32804 | |
| United States, Georgia | |
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| Lawrenceville, Georgia, United States, 30046 | |
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| Marietta, Georgia, United States, 30060 | |
| United States, Illinois | |
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| Harvey, Illinois, United States, 60426 | |
| United States, Indiana | |
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| Fort Wayne, Indiana, United States, 46815 | |
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| Fort Wayne, Indiana, United States, 46845 | |
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| Indianapolis, Indiana, United States, 46254 | |
| United States, Louisiana | |
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| Metairie, Louisiana, United States, 70006 | |
| United States, Nevada | |
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| Las Vegas, Nevada, United States, 89148 | |
| United States, New York | |
| Not yet recruiting | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
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| Hickory, North Carolina, United States, 28602 | |
| United States, Ohio | |
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| Cleveland, Ohio, United States, 44195 | |
| Terminated | |
| Columbus, Ohio, United States, 43215 | |
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| Middletown, Ohio, United States, 45042 | |
| United States, Oregon | |
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| Bend, Oregon, United States, 97701 | |
| United States, Pennsylvania | |
| Not yet recruiting | |
| Duncansville, Pennsylvania, United States, 16635 | |
| United States, Washington | |
| Recruiting | |
| Seattle, Washington, United States, 98195 | |
| Argentina | |
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| Bahia Blanca, Argentina, B8000ILD | |
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| Buenos Aires, Argentina, C1426ANZ | |
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| Buenos Aires, Argentina, B1878DVB | |
| Recruiting | |
| La Rioja, Argentina, F5300COE | |
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| San Miguel de Tucuman, Argentina, T4000IAK | |
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| Santa Rosa, Argentina, L6304BOC | |
| Brazil | |
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| Belo Horizonte, Brazil, 30150-281 | |
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| Botucatu, Brazil, 18618-970 | |
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| Curitiba - Pr, Brazil, 80520-030 | |
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| Fortaleza, Brazil, 60336-550 | |
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| Lajeado, Brazil, 95900-000 | |
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| Movo Hamburgo, Brazil, 93510-250 | |
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| Passo Fundo, Brazil, 99010-260 | |
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| Porto Alegre, Brazil, 90610-000 | |
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| Porto Alegre, Brazil, 90110-270 | |
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| Rio de Janeiro, Brazil, 22260-020 | |
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| Santo Andre, Brazil, 09060-870 | |
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| Santo André - Sp, Brazil, 09080-110 | |
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| Sao Paulo, Brazil, 04024-002 | |
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| São Paulo, Brazil, 01236-030 | |
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| São Paulo, Brazil, 01224-010 | |
| France | |
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| Grenoble, France, 38043 | |
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| Lyon, France, 69373 | |
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| Paris, France, 75230 | |
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| Paris, France, 75674 | |
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| Rennes, France, 35033 | |
| Germany | |
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| Göttingen, Germany, 37075 | |
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| Halle, Germany, 06120 | |
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| Immenhausen, Germany, 34376 | |
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| München, Germany, 81925 | |
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| Münster, Germany, 48149 | |
| Israel | |
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| Afula, Israel, 18101 | |
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| Ashkelon, Israel, 78278 | |
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| Holon, Israel, 58100 | |
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| Tel Aviv, Israel, 64239 | |
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| Zerifin, Israel, 70300 | |
| Italy | |
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| Cremona, Italy, 26100 | |
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| Milano, Italy, 20133 | |
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| Orbassano, Italy, 10043 | |
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| Roma, Italy, 00149 | |
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| Udine, Italy, 33100 | |
| Latvia | |
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| Daugavpils, Latvia, 5417 | |
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| Liepaja, Latvia, 3401 | |
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| Riga, Latvia, 1079 | |
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| Riga, Latvia, LV-1002 | |
| Malaysia | |
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| Kuala Lumpur, Malaysia, 56000 | |
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| Negeri Sembilan, Malaysia, 71800 | |
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| Penang, Malaysia, 10050 | |
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| Pulau Pinang, Malaysia, 11600 | |
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| Tanjung Bungah, Malaysia, 11200 | |
| Mexico | |
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| Aguascalientes, Mexico, 20234 | |
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| Chihuahua, Mexico, 31000 | |
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| Leon, Mexico, 37150 | |
| Philippines | |
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| Davao, Philippines, 8006 | |
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| Davao City, Philippines, 8000 | |
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| Quezon City, Philippines, 1102 | |
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| Quezon City, Philippines, 1104 | |
| Spain | |
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| Barcelona, Spain, 08036 | |
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| Lerida, Spain, 25198 | |
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| Madrid, Spain, 28007 | |
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| Madrid, Spain, 28050 | |
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| Pamplona, Spain, 31008 | |
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| Valencia, Spain, 46009 | |
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| Zaragoza, Spain, 50009 | |
| Taiwan | |
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| Kaohsiung, Taiwan, 807 | |
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| Taichung, Taiwan, 407 | |
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| Tainan, Taiwan, 704 | |
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| Taipei, Taiwan, 11217 | |
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| Taipei, Taiwan, 100 | |
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| Taoyuan, Taiwan, 333 | |
| United Kingdom | |
| Recruiting | |
| Aberdeen, United Kingdom, AB25 2ZN | |
| Recruiting | |
| Birmingham, United Kingdom, B9 5SS | |
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| Bournemouth, United Kingdom, BH7 7DW | |
| Not yet recruiting | |
| Leeds, United Kingdom, LS9 7TF | |
| Recruiting | |
| Manchester, United Kingdom, M23 9QZ | |
Sponsors and Collaborators
Genentech
Investigators
| Study Director: | Clinical Trials | Genentech |
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01496742 History of Changes |
| Other Study ID Numbers: | GO27821, 2011-003719-42 |
| Study First Received: | December 19, 2011 |
| Last Updated: | December 5, 2012 |
| 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 Pemetrexed Bevacizumab 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 Enzyme Inhibitors Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites Angiogenesis Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013