GO30081 Atezolizumab in patients with untreated extensive-stage SCLC

• Research type

  Research Study

• Full title

  A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF CARBOPLATIN PLUS ETOPOSIDE WITH OR WITHOUT ATEZOLIZUMAB (ANTI−PD-L1 ANTIBODY) IN PATIENTS WITH UNTREATED EXTENSIVE-STAGE SMALL CELL LUNG CANCER

• IRAS ID

  199630

• Contact name

  Head, EU/ROW Regulatory Affairs Pharmaceutical Division, PDR

• Contact email

  global.eudract@roche.com

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2015-004861-97

• Duration of Study in the UK

  2 years, 10 months, 16 days

• Research summary

  Lung cancer remains the leading cause of cancer deaths worldwide; it is the most common cancer in men and accounted for ~13% of all new cancers in 2008. In 2012, there were an estimated 313,000 new cases of lung cancer and 268,000 lung cancer deaths in Europe. The United States estimated 221,200 new cases of lung cancer and 158,040 lung cancer deaths in 2015.

  Small cell lung cancer (SCLC) accounts for ~13% of all cases, and is distinguished from Non-small cell lung cancer (NSCLC) by its rapid growth time and early development of metastatic disease.

  70% of patients with SCLC are diagnosed with extensive-stage disease (ES-SCLC), which has poor survival prospects (median overall survival ~10 months).

  Chemotherapy alone can palliate symptoms and prolong survival for patients with ES-SCLC, however long-term survival is rare. The current standard first-line treatment for patients with ES-SCLC is platinum-based chemotherapy with etoposide. Despite the impressive initial response rates observed with first-line chemotherapy regimens, most patients with ES-SCLC develop chemotherapy resistant disease and their prognosis is poor. Therefore, there is a significant need for novel treatments for patients with ES-SCLC.

  Atezolizumab is currently being tested in multiple studies, both as monotherapy and in combination with several anti-cancer therapies. Atezolizumab has shown anti-tumour activity, including Response Evaluation Criteria in Solid Tumours (RECIST v1.1) based responses in patients with several different tumour types, including NSCLC and SCLC.
  The aim of this study is to evaluate the efficacy of atezolizumab+carboplatin+etoposide (Arm A) compared with placebo+carboplatin+etoposide (Arm B) as measured by investigator-assessed Progression Free Survival and Overall Survival.

  Patients will be treated in 21 day cycles and randomised (1:1).

  A planned 400 patients will be enrolled globally with 28 patients in the UK across 8 sites.

  Patients may be considered for treatment beyond progression at the discretion of the investigator if certain criteria are met.
  Lay summary of study results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbSgv9uUS1wsd00iFWSZyptH89w1tcscJeKmImtXTgMdp9S4wFPnP4m0ofIUlvagPpW7yIZDMzBu1moCLEs4aK3PruKUKcQvB6xso88nRJ8SE1kjY5qTk2TIGCykRDUUhS6u-2Be9DU9mmbpGVwkXWgaBiCuDr5uhvltjF8-2F-2BEMgEY3wnhk_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIdHxf-2BKajcrzqnSjLpasTYWBc1kWH0dT46QqMpzwn3fR0LgfUudRfJRiFBE6kqG-2FeYwR6K0VNEowG9xxXuXw7QZZqdMMOVYwW9K2sngroaTKYSeB41TvOFTPTpcp0DnxOwf5zPfWDGiDha-2FOU18UO12pB9eSGVnwtyzVOhGhWnRg-3D-3D&data=05%7C01%7Cleicestercentral.rec%40hra.nhs.uk%7C698852211cfd4583213908db7714eb3e%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638234703945291180%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=titO2Ibovn29kMaLzOh40G4Acyh4bjNCGzgZDFGDJNo%3D&reserved=0

  summary results:
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRehJ-2Fi4xyo44sEgJVCl5Bdj8o1FpylFwbn362DUDJ-2FzD8b3wMIgsJGWaj9UBChqviR7roZbFZ4o3a9E6uslexKx7IYHTJsRy1VO6Ubosm33USUgbqturEIt1eTIrZNpYg-3D-3DvTQ2_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIdHxf-2BKajcrzqnSjLpasTY-2BVaTw818R7zht3L8pmfyS8mj4Sh9FSiUL6rzZFBTMB8YngHpjhFdrzRQmp-2BWova7Sp1yBAqf8zH3wvNY0AvXnCmyCKIPj0LrxYSZWbpY-2B5dTtrUufwuhS00PngQByIVSSVcM0HamWfG-2BECwQ7Evk-2FA-3D-3D&data=05%7C01%7Cleicestercentral.rec%40hra.nhs.uk%7C698852211cfd4583213908db7714eb3e%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638234703945291180%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=8uMArYdljTBBsgzyKSbd4bScPUM4RK2ZcyqAKGyXjqo%3D&reserved=0

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  16/EM/0198

• Date of REC Opinion

  27 May 2016

• REC opinion

  Further Information Favourable Opinion