Clinical trial NCT01519804: A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2012-01-27
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Progression-free survival (tumor assessments according to RECIST criteria)
timeFrame: up to approximately 32 months
measure: Progression-free survival: Subgroup of patients with Met diagnostic-positive squamous NSCLC
timeFrame: up to approximately 32 months
Secondary outcomes:
measure: Overall survival
timeFrame: up to approximately 32 months
measure: Overall response rate (tumor assessments according to RECIST criteria)
timeFrame: up to approximately 32 months
measure: Duration of response (time from first documented objective response to disease progression)
timeFrame: up to approximately 32 months
measure: Disease control rate (rate of partial response plus complete response plus stable disease for at least 6 weeks)
timeFrame: up to approximately 32 months
measure: Safety: Incidence of adverse events
timeFrame: up to approximately 32 months
measure: Pharmacokinetics: serum concentration (Cmin/Cmax)
timeFrame: Pre- and post-dose on Day 1 of Cycles 1, 2 and 4 and up to 2 years
measure: Plasma concentrations of paclitaxel/platinum
timeFrame: Pre- and post-dose on Day 1 of Cycles 1 and 4
measure: Serum levels of anti-therapeutic antibodies (MetMAb ATAs)
timeFrame: Pre-dose Day 1 of Cycles 1, 2 and 4
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Scottsdale
country: United States
state: Arizona
city: Bakersfield
country: United States
state: California
city: Fullerton
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Northridge
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Luis Obispo
country: United States
state: California
city: Santa Barbara
country: United States
state: California
city: Stanford
country: United States
state: California
city: Grand Junction
country: United States
state: Colorado
city: Boynton Beach
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Weston
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Harvey
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Fort Wayne
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Muncie
country: United States
state: Indiana
city: Metairie
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Minneapolis
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Hickory
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Middletown
country: United States
state: Ohio
city: Bend
country: United States
state: Oregon
city: Pittsburgh
country: United States
state: Pennsylvania
city: Seattle
country: United States
state: Washington
city: Buenos Aires
country: Argentina
city: La Rioja
country: Argentina
city: Santa Rosa
country: Argentina
city: Grenoble
country: France
city: Lyon
country: France
city: Paris
country: France
city: Rennes
country: France
city: Berlin
country: Germany
city: Göttingen
country: Germany
city: Halle (Saale)
country: Germany
city: Immenhausen
country: Germany
city: München
country: Germany
city: Münster
country: Germany
city: Afula
country: Israel
city: Ashkelon
country: Israel
city: Tel Aviv
country: Israel
city: Zerifin
country: Israel
city: Avellino
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Udine
country: Italy
state: Friuli-Venezia Giulia
city: Cremona
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Daugavpils
country: Latvia
city: Liepaja
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Pamplona
country: Spain
state: Navarra
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Zaragoza
country: Spain
city: Aberdeen
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Bournemouth
country: United Kingdom
city: Leeds
country: United Kingdom
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: