Lung Cancer GO29527
May 09, 2017
Sponsor: Hoffmann-La Roche
Number: GO29527
Eligible patients who enroll in the study will be randomly assigned (by chance) to this Phase III, global, multicenter, open-label, study to compare the efficacy and safety of 16 cycles (1 cycle duration=21 days) of Atezolizumab (MPDL3280A) treatment compared with best supportive care (BSC). This study is for participants with Stage IB-Stage IIIA 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. These patients would be following resection and adjuvant chemotherapy (therapy given after surgery), as measured by disease-free survival (DFS) as assessed by the investigator and overall survival (OS). Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will be randomized in a 1:1 ratio to receive Atezolizumab for 16 cycles or BSC.
Who’s eligible:
- Histological (tissue microscopically examined) or cytological (fluid cells microscopically examined) diagnosis of Stage IB (tumors greater than or equal to [>/=] 4 centimeters [cm])-IIIA (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) (Click here for lung cancer staging definitions) NSCLC (per the Union Internationale Contre le Cancer staging system (UICC)/American Joint Committee on Cancer staging system (AJCC) staging system, 7th edition; Detterbeck et al. 2009).
- Participants must have had complete resection of NSCLC 4-12 weeks (>/=28 days and less than or equal to [
- Women who are not postmenopausal (>/=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days, prior to initiation of Cisplatin-based chemotherapy.
- This study is for patients age 18 and older.
Available at: Backus Hospital- Eastern Connecticut Hematology and Oncology.