Cancer types
  • Lung
Title of study
A randomised open-label phase II trial of consolidation with nivolumab and ipilimumab in limited-stage SCLC after chemo-radiotherapy
Version Number
Approval Date 
2.0, 03 August 2015
Short Title
Stimuli
Study site
Principle Investigator
S. Peters, MD-PhD
Investigator Maastro
D. DeRuysscher, MD, PhD
Sponsor
European Thoracic Oncology Platform
WHO Trial Registry
DUCG
ClinicalTrials.gov
Objectives 

• To evaluate whether patients treated with chemo-radiotherapy and prophylactic cranial irradiation followed by nivolumab plus ipilimumab consolidation treatment have a better out-come in terms of progression-free survival (PFS) and overall survival (OS) compared to patients treated with chemo-radiotherapy and prophylactic cranial irradiation without consolidation treatment
• To evaluate secondary measures of clinical efficacy including objective response rate (ORR), and time to treatment failure
• To assess the safety and the tolerability of the treatment in both arms

Primary Endpoint 

• Progression-free survival (PFS) according to RECIST 1.1 5.3.2.
• Overall survival (OS)

Secondary Endpoints 

• Objective response determined by RECIST 1.1 5.4.2.
• Time to treatment failure 5.4.3.
• Adverse events graded according to CTCAE V4.0