Abstract 2136
Background
Most pts with newly diagnosed NSCLC have locally advanced or metastatic disease, with 30%-40% having poor performance status (ECOG PS ≥ 2) due to disease burden and comorbidities. These pts have poor prognosis vs pts with PS
Trial design
Eligible pts have Stage IIIB/IV NSCLC; are considered unsuitable for plat-based chemo due to poor PS (ECOG PS 2-3); have substantial comorbidities or contraindications for plat-based doublet chemo; have measurable disease; have no EGFR/ALK mutations and have received no prior systemic therapy. Pts will be randomized 2:1 to receive atezo 1200 mg IV q3w or single-agent chemo (vin [PO/IV], gem [IV]) per local practice until PD. Pts on atezo may continue therapy until loss of clinical benefit. Stratification factors include histology subtype (squamous vs nonsquamous), PD-L1 status (by VENTANA SP142 IHC assay) and presence of brain metastases. Primary endpoint is OS. Secondary endpoints include OS at 6, 12, 18 and 24 mo; ORR; PFS; DOR and safety. Tumor biopsies and blood samples (pre-treatment all mandatory; at PD only blood mandatory) will be assessed for biomarkers associated with atezo responses and immune escape. Planned enrollment is ≈ 441 pts.
Clinical trial identification
NCT pending (available on poster)
Legal entity responsible for the study
F. Hoffmann-La Roche Ltd.
Funding
F. Hoffmann-La Roche Ltd.
Disclosure
S.M. Lee: Advisory Board for Roche, Merck, Bristol‐Myers, Astra Zeneca. C. Schulz: Scientific Advisor or Membership: AstraZeneca, BMS, Boehringer, Lilly, Novartis, Roche Honoraria: AstraZeneca, Celgene, BMS, Boehringer, Lilly, Novartis, Roche. A. Cardona: Roche employee. P. Bartakova: F. Hoffmann-La Roche employee and company stock ownership. S. Peters: Edu grants, consultation, AB, lectures: Amgen, AZ, BI, BMS, Clovis, Eli Lilly, F. Hoffmann-La Roche, Guardant health, Janssen, Merck Sharp and Dohme, and Merck Serono, Merrimack, Morphotek, Pfizer, Regeneron, Takeda.