1376TiP - Phase III study of atezolizumab (atezo) vs chemotherapy (chemo) in patients (pts) with treatment-naive advanced, recurrent or metastatic NSCLC unsu...

Date 09 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Anti-Cancer Agents & Biologic Therapy
Cancer in Adolescents
Non-Small-Cell Lung Cancer, Locally Advanced
Non-Small-Cell Lung Cancer, Metastatic
Cancer Immunology and Immunotherapy
Lung and other Thoracic Tumours
Presenter Siow Ming Lee
Citation Annals of Oncology (2017) 28 (suppl_5): v460-v496. 10.1093/annonc/mdx380
Authors S.M. Lee1, C. Schulz2, A. Cardona3, P. Bartakova4, S. Peters5
  • 1Department Of Oncology, UCLH/UCL Cancer Institute/Cancer Research UK Lung Cancer Centre of Excellence, NW1 2PG - London/GB
  • 2Department Of Internal Medicine Ii, University Hospital Regensburg, Regensburg/DE
  • 3Pdma Biometrics, F. Hoffmann-La Roche Ltd., Basel/CH
  • 4Global Product Development Medical Affairs (oncology), F. Hoffmann-La Roche Ltd., Basel/CH
  • 5Oncology, Centre Hospitalier Universitaire Vaudois, 1011 - Lausanne/CH

Abstract

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.