| TITRE |
(EN) 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 |
| PROTOCOLE ID |
OAM4971g (McG 1213) |
| CLINICAL TRIAL.gov ID |
NCT01456325 |
| TYPE(S) DE CANCER |
Poumon non à petites cellules |
| PHASE |
Phase III |
| TYPE D'ÉTUDE |
|
| INSTITUTION |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Vera Hirsh
|
| COORDONATEUR(RICE) |
|
| STATUT |
Fermé
|
| DATE D'ACTIVATION |
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- 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
|
| CRITÈRES D'EXCLUSION |
(EN)
- 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
|
