Clinical trial NCT01887886: A Study of Onartuzumab in Combination With Erlotinib in Patients With MET-Positive Stage IIIB or IV Non-Small Cell Lung Cancer Carrying an Activating Epidermal Growth Factor Receptor (EGFR) Mutation
Official title: A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab in Combination With Erlotinib as First-Line Treatment for Patients With MET-Positive Unresectable Stage IIIb or IV Non-Small Cell Lung Cancer (NSCLC) Carrying an Activating EGFR Mutation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-06-27
Enrollment: 10
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 safety and efficacy of onartuzumab in combination with erlotinib in patients with previously untreated, unresectable stage IIIB or IV non-small cell lung cancer identified to carry and activating EGFR mutation and MET-positive. Patients will be randomized to receive either onartuzumab 15 mg/kg intravenously every 3 weeks in combination with erlotinib 150 mg orally daily or placebo in combination with erlotinib. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility criteria: Inclusion Criteria:

* Adult patient, \>/= 18 years of age
* Histologically confirmed, unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC)
* No prior treatment for unresectable Stage IIIB or IV NSCLC
* Measurable radiographic evidence of disease according to RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Prior exposure to agents targeting either the Hepatocyte Growth Factor (HGF) or MET pathway
* Exposure to an investigational or marketed agent that can act by EGFR inhibition
* Pleural effusion, pericardial fluid, or ascites requiring drainage every other week or more frequently
* Brain metastasis or spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated central nervous system (CNS) metastases or spinal cord compression without evidence of clinically stable disease for \>/=4 days. Note: Patients with treated CNS metastases who are asymptomatic and on a stable dose of corticosteroids for \>/= 14 days prior to randomization are eligible.
* History of another malignancy in the previous 5 years, unless cured by surgery alone and continuously disease-free
* Radiographically evident interstitial lung disease , concurrent infection, or a history of any of these conditions
* Inadequate hematologic, biochemical, and organ function
* Pregnant or lactating women
* Life expectancy of \< 12 weeks
* Receipt of an investigational drug within 28 days prior to initiation of study treatment

Primary outcomes:
measure: Progression-free survival (investigator-assessed according to RECIST v1.1)
timeFrame: approximately 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: approximately 3 years
measure: Overall response rate
timeFrame: approximately 3 years
measure: Time to deterioration (>/= 10 points [transformed score] from baseline) in patient-reported lung cancer symptoms
timeFrame: approximately 3 years
measure: Patient reported outcomes: HRQoL/EORTC QLC-C30/EORTC QLQ-LC31 questionnaires
timeFrame: approximately 3 years
measure: Safety: Incidence of adverse events
timeFrame: approximately 3 years
measure: Pharmacokinetics: Area under the concentration-time curve (AUC)
timeFrame: Day 1 Cycles 1, 2 and 4
Other outcomes:
Locations:
city: Bakersfield
country: United States
state: California
city: Fullerton
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Luis Obispo
country: United States
state: California
city: Fort Myers
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Marrero
country: United States
state: Louisiana
city: Metairie
country: United States
state: Louisiana
city: St. Louis
country: United States
state: Missouri
city: Canton
country: United States
state: Ohio
city: Nashville
country: United States
state: Tennessee
city: Caen
country: France
city: Lyon
country: France
city: Nantes
country: France
city: Grosshansdorf
country: Germany
city: Oldenburg
country: Germany
city: Villingen-Schwenningen
country: Germany
city: Ehime
country: Japan
city: Okayama
country: Japan
city: Yamaguchi
country: Japan
city: Gwangju
country: Korea, Republic of
city: Suwon-si,
country: Korea, Republic of
city: Tanjung Bungah
country: Malaysia
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: