An Open-Label Randomized Phase III Trial of BMS-936558 (nivolumab) versus Docetaxel in Previously Treated Metastatic Non-squamous Non-small cell Lung Cancer (NSCLC).
To compare overall response and survival of BMS936558 (anti PD 1 study drug) to Docetaxel in subjects with previously treated advanced or metastatic non-squamous cell non-small cell lung cancer.
Subjects with histologically or cytologically documented non-squamous cell NSCLC with stage IIIB/or stage IV disease that have experienced recurrence or progression during or after one prior platinum doublet chemotherapy regimen for advanced or metastatic disease. Subjects must have good performance status (ECOG PS less than 1), measureable disease by CT or MRI, tissue block or unstained slides sent to central lab prior to randomization. Patients may have treated, stable CNS greater than 2 weeks prior to enrollment. Excluded are patients with autoimmune diseases, prior Docetaxel treatment, and active malignancy requiring intervention within last 2 years. Toxicities from prior treatment anti-cancer treatment less than grade 1.
This is a phase III, open label, randomized study. Eligible patients will be randomized to receive BMS936558 q 2 weeks or Docetaxel q 3 weeks until disease progression. Patients receiving BMS936558 with a clinical benefit may continue on therapy following PD with stable performance status and continues to meet eligibility. In both arms, patient receives Infusion on Day 1, first CT at 9 weeks, then q 6 weeks thereafter until disease progression. There are biomarker, PK & immunogenicity sample collection that vary depending on Arm assignment. Patient reported outcome surveys (LUNG Cancer Symptom Scale & EuroPRO ) will be completed after eligibility & then every other cycle for first 6 months of study.
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