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

CompletadoFase 3ClinicalTrials.gov

ID: NCT01456325Tipo: INTERVENTIONALInicio: 1 de ene de 2012Fin estimado: 1 de ene de 2016

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Erlotinib

Participants will receive erlotinib 150 mg tablet orally once daily from Day 1, Cycle 1.

drug

Onartuzumab (MetMab)

Participants will receive onartuzumab 15 mg/kg IV infusion on Day 1 of every 3-week cycle.

drug

Placebo

Participants will receive onartuzumab matching placebo on Day 1 of every 3-week cycle.

Ubicaciones

La Plata, Argentina

Quilmes, Argentina

Santa Fe, Argentina

Patrocinadores

PrincipalGenentech, Inc.

ColaboradorHoffmann-La Roche

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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