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

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:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Paclitaxel Carboplatin

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 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:	110
Study Start Date:	April 2012
Estimated Study Completion Date:	October 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 Other Name: MetMAb 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: Please reference Study ID Number: GO27820 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

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Locations

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
	Recruiting
Bakersfield, California, United States, 93309
	Recruiting
Fullerton, California, United States, 92835
	Recruiting
Los Angeles, California, United States, 90024
	Recruiting
Northridge, California, United States, 91325
	Recruiting
Redondo Beach, California, United States, 90277
	Recruiting
Sacramento, California, United States, 95817
	Terminated
Santa Barbara, California, United States, 93105
	Recruiting
Santa Barbara, California, United States, 93105
	Recruiting
Santa Maria, California, United States, 93454
	Recruiting
Stanford, California, United States, 94305
United States, Colorado
	Recruiting
Grand Junction, Colorado, United States, 81502-1628
United States, Florida
	Recruiting
Boynton Beach, Florida, United States, 33435
	Recruiting
Orlando, Florida, United States, 32804
	Recruiting
Weston, Florida, United States, 33331
United States, Georgia
	Recruiting
Marietta, Georgia, United States, 30060
United States, Illinois
	Not yet recruiting
Chicago, Illinois, United States, 60611
	Recruiting
Harvey, Illinois, United States, 60426
United States, Indiana
	Recruiting
Fort Wayne, Indiana, United States, 46815
	Recruiting
Fort Wayne, Indiana, United States, 46845
	Recruiting
Indianapolis, Indiana, United States, 46260
	Not yet recruiting
Muncie, Indiana, United States, 47303
United States, Louisiana
	Recruiting
Metairie, Louisiana, United States, 70006
United States, Massachusetts
	Recruiting
Boston, Massachusetts, United States, 02114
	Recruiting
Boston, Massachusetts, United States, 02215
United States, Minnesota
	Not yet recruiting
Minneapolis, Minnesota, United States, 55454
United States, Missouri
	Recruiting
St. Louis, Missouri, United States, 63110
United States, Nevada
	Recruiting
Las Vegas, Nevada, United States, 89148
United States, North Carolina
	Recruiting
Hickory, North Carolina, United States, 28602
United States, Ohio
	Not yet recruiting
Cleveland, Ohio, United States, 44195
	Recruiting
Middletown, Ohio, United States, 45042
United States, Oregon
	Recruiting
Bend, Oregon, United States, 97701
United States, Pennsylvania
	Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Washington
	Recruiting
Seattle, Washington, United States, 98195
Argentina
	Recruiting
Buenos Aires, Argentina, C1426ANZ
	Not yet recruiting
Buenos Aires, Argentina, B1878DVB
	Recruiting
La Rioja, Argentina, F5300COE
	Not yet recruiting
San Miguel de Tucuman, Argentina, T4000IAK
	Recruiting
Santa Rosa, Argentina, L6304BOC
Brazil
	Not yet recruiting
Belo Horizonte, Brazil, 30150-281
	Not yet recruiting
Curitiba, Brazil, 81520-060
	Not yet recruiting
Fortaleza, Brazil, 60336-550
	Not yet recruiting
Porto Alegre, Brazil, 90610-000
	Not yet recruiting
Porto Alegre - Rs, Brazil, CEP 90840-
	Not yet recruiting
Rio de Janeiro, Brazil, 22260-020
	Not yet recruiting
Santo Andre, Brazil, 09060-870
	Not yet recruiting
Sao Paulo, Brazil, 01236-030
	Not yet recruiting
São Paulo, Brazil, 01224-010
France
	Recruiting
Grenoble, France, 38043
	Recruiting
Lyon, France, 69373
	Recruiting
Paris, France, 75674
	Recruiting
Rennes, France, 35033
Germany
	Recruiting
Berlin, Germany, 12203
	Recruiting
Göttingen, Germany, 37075
	Recruiting
Halle, Germany, 06120
	Recruiting
Immenhausen, Germany, 34376
	Recruiting
München, Germany, 81925
	Recruiting
Münster, Germany, 48149
Israel
	Recruiting
Afula, Israel, 18101
	Recruiting
Ashkelon, Israel, 78278
	Recruiting
Tel Aviv, Israel, 64239
	Recruiting
Zerifin, Israel, 70300
Italy
	Recruiting
Avellino, Italy, 83100
	Recruiting
Cremona, Italy, 26100
	Recruiting
Milano, Italy, 20133
	Recruiting
Napoli, Italy, 80131
	Not yet recruiting
Roma, Italy, 00152
	Recruiting
Udine, Italy, 33100
Latvia
	Recruiting
Daugavpils, Latvia, 5417
	Recruiting
Liepaja, Latvia, 3401
	Recruiting
Riga, Latvia, LV-1002
	Recruiting
Riga, Latvia, 1079
Spain
	Recruiting
Barcelona, Spain, 08036
	Recruiting
Madrid, Spain, 28050
	Recruiting
Madrid, Spain, 28007
	Recruiting
Pamplona, Spain, 31008
	Recruiting
Zaragoza, Spain, 50009
United Kingdom
	Recruiting
Aberdeen, United Kingdom, AB9 2ZB
	Recruiting
Birmingham, United Kingdom, B9 5SS
	Recruiting
Bournemouth, United Kingdom, BH7 7DW
	Recruiting
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:	February 5, 2013
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 May 22, 2013