1431TiP - A Phase III study of atezolizumab with carboplatin plus etoposide in patients with extensive-stage small cell lung cancer (IMpower133)

Date 08 October 2016
Event ESMO 2016 Congress
Session Poster Display
Topics Small Cell Lung Cancer
Presenter Leora Horn
Citation Annals of Oncology (2016) 27 (6): 493-496. 10.1093/annonc/mdw389
Authors L. Horn1, M. Reck2, T.S.K. Mok3, M. Johnson4, D. Waterkamp5, S. Lam5, X. Tang6, A. Sandler5, A. Lopez-Chavez5, G. Giaccone7, S.V. Liu7
  • 1Department Of Medicine, Vanderbilt Ingram Cancer Center, 37212 - Nashville/US
  • 2Thoracic Oncology, Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), member of the German Center for Lung Research (DZL), 22927 - Grosshansdorf/DE
  • 3Oncology, Chinese University of Hong Kong, Hong Kong/HK
  • 4Oncology, Sarah Cannon Research Institute/Tennessee Oncology, Nashville/US
  • 5Product Development Oncology, Genentech, Inc., South San Francisco/US
  • 6Pdbb, F. Hoffmann-La Roche Ltd, Shanghai/CN
  • 7Oncology, Lombardi Comprehensive Cancer Center, Georgetown University, Washington, D.C./US

Abstract

Background

The current standard first-line treatment for the majority of patients (pts) with extensive-stage small cell lung cancer (ES-SCLC) is platinum-based chemotherapy with etoposide. Despite initial response rates ranging from 50% to 70%, median survival remains 

Trial design

IMpower133 is a randomized, Phase III, multicenter, double-blinded, placebo-controlled study evaluating the efficacy and safety of atezo + CE vs placebo + CE in treatment-naive pts with ES-SCLC. Pts will be enrolled regardless of PD-L1 expression status. Pts with untreated CNS metastases, autoimmune disease or prior anti-cancer therapy for ES-SCLC will be excluded. Eligible pts will be stratified by sex, ECOG PS and presence of brain metastases, and randomized 1:1 to treatment arms. The induction phase of the study will consist of four 21-day cycles of atezo (1200 mg IV) or placebo with CE (C AUC 5, day 1 + E 100 mg/m2, days 1-3) followed by maintenance atezo or placebo until PD per RECIST v1.1. Treatment can be continued until persistent radiographic PD or symptomatic deterioration. Investigator-assessed PFS per RECIST v1.1 and OS are the co-primary endpoints. Secondary endpoints include ORR, DOR, quality of life, safety/tolerability and pharmacokinetics. Approximately 400 pts will be enrolled globally.

Clinical trial identification

NCT: available on poster

Legal entity responsible for the study

F. Hoffmann-La Roche Ltd

Funding

F. Hoffmann-La Roche Ltd

Disclosure

L. Horn: Research: AZ Consulting: Bayer, BI, BMS, Genentech, Lilly, Merck and Xcovery. M. Reck: Consulting/Advisory role and Speaker Bureau for Roche, lIlly, BMS, MSD, AshaZ Zeneca, Pfizer, Boehringer Ingeleim, Celgene. T.S.K. Mok: Leadership/Stocks: Sanomics Ltd Honoraria/Consulting/Research includes: AZ, Roche, Lily, Merck, MSD, BMS, BI, Novartis, Clovis Onc, Amgen, Janssen, AVEO, Biodesix, Prime Oncology, ACEA Biosciences, Vertex, SFJ, GSK, Biomarin, Pfizer. D. Waterkamp: Roche/Genentech employee and stock. S. Lam, A. Sandler: Genentech employee, Roche stock. X. Tang: Roche employee. A. Lopez-Chavez: Genentech employee. G. Giaccone: Consulting or Advisory Role: Clovis, Boehringer- Ingelheim, Celgene Research grants: Karyopharm, Astra-Zeneca; Eli-Lilly. S.V. Liu: Consulting or Advisory Role: Genentech, Boehringer Ingelheim, Ariad, Biodesix, Perthera. All other authors have declared no conflicts of interest.