A Study of Onartuzumab (MetMAb) in Combination With Tarceva (Erlotinib) in Patients With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Chemotherapy For Advanced or Metastatic Disease (MetLung)
Status: | Completed |
---|---|
Conditions: | Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/3/2016 |
Start Date: | July 2011 |
End Date: | January 2016 |
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
This randomized, multicenter, double-blind, placebo-controlled study will evaluate the
efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in
patients with incurable non-small cell lung cancer identified to be Met diagnostic-positive.
Patients will be randomized to receive either onartuzumab (MetMAb) or placebo in combination
with Tarceva. Anticipated time on study treatment is until disease progression or
unacceptable toxicity occurs.
efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in
patients with incurable non-small cell lung cancer identified to be Met diagnostic-positive.
Patients will be randomized to receive either onartuzumab (MetMAb) or placebo in combination
with Tarceva. Anticipated time on study treatment is until disease progression or
unacceptable toxicity occurs.
Inclusion Criteria:
- Adult patients, >/= 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 IHC
- Results of 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; patients 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 patient 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 HIV infection
We found this trial at
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