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)

Trial ID:
IRB-14-6375
Michael Kosty
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.

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) non-small cell lung cancer (NSCLC)
  • Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
  • 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

Exclusion Criteria:

  • 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

Contact Info:

  • Reference Study ID Number: GO28915 www.roche.com/about_roche/roche_worldwide.htm
  • global.rochegenentechtrials@roche.com
  • 888-662-6728