Lung Cancer GO29537

May 09, 2017

Sponsor: Hoffmann-La Roche

Number: GO29537

Eligible patients who enroll in the study will be randomly assigned (by chance) to this Phase III, multicenter, open-label study which is designed to evaluate the safety and efficacy of Atezolizumab (MPDL3280A) in combination with Carboplatin + Nab-Paclitaxel compared with treatment with Carboplatin + Nab-Paclitaxel in chemotherapy-naive patients with Stage IV non-squamous non-small cell lung cancer (NSCLC). Phase III trials: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. Stage IV is non-small cell lung cancer which has spread from the site of the primary (original) tumor only to surrounding tissue.

Who’s eligible:

• The Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1. ECOG status is used by your doctor in order to assess how your disease is progressing, assess how the disease effects of your daily living abilities, and determine appropriate treatment and prognosis.
• The patient must have a histologically (tissue microscopically examined) or cytologically confirmed (fluid cells microscopically examined), treatment-naive Stage IV non-squamous NSCLC. Stage IV cancer is the development of secondary malignant growths at a distance from a primary site of cancer.
• There must be measurable disease, as defined by RECIST v1.1 (a set of published rules that define when tumors in cancer patients improve (respond), stay the same (stabilize), or worsen ("progress") during treatment).
• There must be previously obtained archival tumor or tissue obtained from a biopsy at screening. The patient must have adequate hematologic and end organ function.
• This study is for patients age 18 and older.

Available at: Backus Hospital- Eastern Connecticut Hematology and Oncology.