A randomized, phase III, multicenter, double-blind, placebo-contolled study of evaluating the efficacy and safety of Onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in patients with MET diagnostic-positive non-small cell lung cancer (NSCLC) who have received standard chemotherapy for advanced or metastatic disease.
This is a randomized, Phase III, multicenter, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of Onartuzumab (MetMAb) in combination with erlotinib as compared with treatment with erlotinib alone in patients with incurable NSCLC identified to be Met diagnostic positive.
Patients must meet the following criteria for study entry:
• Signed, written informed consent prior to any study-specific screening procedure
• Male or female, 18 years of age or older.
• Patients with ECOG performance status of 0–1 (see Appendix C)
• Histologically or cytologically confirmed incurable Stage IIIb/IV NSCLC tumor
• Met diagnostic-positive status (≥ 50% of tumor cells with membrane and/or cytoplasmic staining at moderate to high intensity) and results of EGFR-activating mutation testing, as determined by the central laboratory
- Tumor tissue sample requirements are described in Section 4.5.1.g.
- An informed consent form is available under which a patient's archival tumor block or slides may be sent for central Met and EGFR testing while the patient is undergoing initial or first-line therapy.
• Radiographic evidence of disease (measurable disease not mandatory)
- The lesions must be outside a previous radiotherapy field if they are the sole site of disease, unless disease progression has been documented at that site since radiation.
• Prior treatment with at least one platinum-based line of treatment for locally advanced, resectable/inoperable disease or metastatic disease, and no more than one additional line of chemotherapy treatment
-Adjuvant/neoadjuvant chemotherapy or chemiradiation counts as a line of therapy if <12 months have elapsed between the last dose and the date of recurrence
-Maintenance therapy with a cytotoxic regimen that differs from first-line therapy is considered an additional line of therapy. However, a change of systemic regimen for reasons of intolerance or excessive toxicity does not constitute an additional regimen.
- The last dose of prior chemotherapy must have been administered ≥ 21 days prior to Day 1 (≥ 14 days for vinorelbine or other vinca alkaloids or gemcitabine)
(Anti-cancer agents used for pheurodesis are not counted as a line of therapy.
- Prior radiation therapy is allowed provided the patient has recovered from any toxic effects thereof and ≥ 7 days have elapsed between the last fraction and randomization (see separate criteria regarding brain or spinal cord metastases).