A Phase III, Open-Label, Multicenter, Randomized Study To Investigate The Efficacy And Safety Of MPDL3280a (Anti-Pd-L1 Antibody) Compared With Docetaxel In Patients With Non-Small Cell Lung Cancer After Failure With Platinum-Containing Chemotherapy (Protocol GO28915)
This global, multicenter, open-label, randomized, controlled study will evaluate the
efficacy and safety of MPDL3280A compared with docetaxel in patients with l ocally advanced
or metastatic non-small cell lung cancer (NSCLC) after failure w ith platinum-containing
chemotherapy. Patients will be randomized 1:1 to receive either docetaxel (75 mg/m2
intravenous infusion) or MPDL3280A (1200 mg intraven ous infusion) every three weeks.
Treatment may continue for up to 16 cycles (or 12 months, whichever comes first) in the
absence of unacceptable toxicity or dis ease progression.
Adult patients, >/= 18 years of age
Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) non-small cell lung cancer (NSCLC)
Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen
Measurable disease, as defined by RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Known active or untreated central nervous system (CNS) metastases
Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
History of autoimmune disease
History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
Active hepatitis B or hepatitis C
Prior treatment with docetaxel
Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
Reference Study ID Number: GO28915 www.roche.com/about_roche/roche_worldwide.htm