Non-Squamous Non-Small Cell Lung Cancer
Conditions
Brief 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.
Interventions
DRUGErlotinib
Participants will receive erlotinib 150 mg tablet orally once daily from Day 1, Cycle 1.
Participants will receive onartuzumab 15 mg/kg IV infusion on Day 1 of every 3-week cycle.
DRUGPlacebo
Participants will receive onartuzumab matching placebo on Day 1 of every 3-week cycle.
Sponsors
Hoffmann-La Roche
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | Randomization until death (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice) |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, Croatia, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Peru, Poland, Russia, Serbia, South Africa, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States
Outcome results
None listed