A Study of Onartuzumab (MetMAb) in Combination With Tarceva (Erlotinib) in Participants With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Chemotherapy For Advanced or Metastatic Disease (MetLung)

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Onartuzumab (Metmab) in Combination With Tarceva (Erlotinib) in Patients With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Standard Chemotherapy for Advanced/Metastatic Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01456325
• Other study ID #: OAM4971g
• Secondary ID: GO277612011-0022
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2011
• Last updated: November 1, 2016
• Start date: January 2012
• Est. completion date: January 2016

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in participants with incurable non-small cell lung cancer identified to be Met diagnostic-positive. Participants will be randomized to receive either onartuzumab (MetMAb) or placebo in combination with erlotinib. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult participants, greater than or equal to (>/=) 18 years of age

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1

• Histologically or cytologically confirmed incurable Stage IIIb/IV NSCLC tumor

• Met diagnostic-positive status tested by immunohistochemistry (IHC)

• Results of endothelial growth factor receptor (EGFR)-activating mutation testing

• Radiographic evidence of disease

• Prior treatment with at least one platinum-based line of treatment (for stage IIIb/IV) and no more than one additional line of chemotherapy treatment; the last dose of chemotherapy must have been administered >/= 21 days prior to Day 1

• availability of tissue sample for diagnostic testing is required

Exclusion Criteria:

• More than 30 days of exposure to an investigational or marketed agent that can act by EGFR inhibition, or a known EGFR-related toxicity resulting in dose modifications (EGFR inhibitors including but not limited to gefitinib, erlotinib and cetuximab)

• Brain metastases or spinal cord compression not definitively treated with surgery and/or radiation, or previously treated central nervous system (CNS) metastases or spinal cord compression without evidence of stable disease for >/= 14 days

• History of another malignancy in the previous 3 years, unless cured by surgery alone and continuously disease free for at least 3 years; participants with prior history of non-invasive cancers are eligible

• Inadequate hematological, biochemical or organ function

• Significant history of cardiac disease

• Serious active infection at time of randomization or other serious underlying medical conditions that would impair the ability of the participant to receive protocol treatment

• Any inflammatory changes of the surface of the eye

• Clinically significant gastro-intestinal disease, including uncontrolled inflammatory gastro-intestinal diseases

• Pregnant or lactating women

• Positive for human immunodefinciency (HIV) infection

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Neoplasm Metastasis
• Non-Squamous Non-Small Cell Lung Cancer

Intervention

Drug:
• Erlotinib
Participants will receive erlotinib 150 mg tablet orally once daily from Day 1, Cycle 1.
• Onartuzumab (MetMab)
Participants will receive onartuzumab 15 mg/kg IV infusion on Day 1 of every 3-week cycle.
• Placebo
Participants will receive onartuzumab matching placebo on Day 1 of every 3-week cycle.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Genentech, Inc.	Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Chile,  Croatia,  France,  Germany,  Hong Kong,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Peru,  Poland,  Russian Federation,  Serbia,  South Africa,  Spain,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		Randomization until death (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)	No
Secondary	European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) Scores		Screening, Day 1 of Cycles 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 (cycle length = 21 days), study drug discontinuation visit (up to approximately 18 months)	No
Secondary	Onartuzumab Serum Concentrations		1 hour pre-onartuzumab (Pr-O) infusion on Day 1 of Cycles 1, 2, and 4, 1 hour post-onartuzumab (Po-O) infusion on Day 1 of Cycle 1 (cycle length = 21 days and duration of infusion = 60 minutes), End of treatment (up to approximately 18 months)	No
Secondary	Percentage of Participants With Disease Progression or Death		Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)	No
Secondary	Progression Free Survival (PFS)		Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)	No
Secondary	Percentage of Participants with an Objective Response Assessed Using RECIST V 1.1		Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)	No