A Study of Onartuzumab in Combination With Erlotinib in P... | NCT01887886

Studies
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

NCT01887886

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

10Actual

Phase

Phase 3

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Interventions

erlotinib
onartuzumab
placebo

Countries

United States
France
Germany
Japan
Malaysia
South Korea
Spain
Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2013-000868-29	EudraCT Number

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Jun 25, 2013

First Submission Date that Met QC Criteria

Jun 25, 2013

First Posted Date

Jun 27, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jul 20, 2016

Certification/Extension First Submitted that Passed QC Review

Jul 20, 2016

Certification/Extension First Posted Date

Jul 22, 2016Estimated

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Label	Type	Description	Intervention Names
Onartuzumab + Erlotinib	Experimental		Drug: erlotinib Drug: onartuzumab
Placebo + Erlotinib	Active Comparator		Drug: erlotinib Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
erlotinib	Drug	150 mg orally daily	Onartuzumab + Erlotinib Placebo + Erlotinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free survival (investigator-assessed according to RECIST v1.1)		approximately 3 years

Secondary Outcomes

Measure	Description	Time Frame
Overall survival		approximately 3 years
Overall response rate		approximately 3 years
Time to deterioration (>/= 10 points [transformed score] from baseline) in patient-reported lung cancer symptoms

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Bakersfield	California	93309	United States

ID	Term
D000069347	Erlotinib Hydrochloride
C584058	onartuzumab

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds