Cancer types
  • Lung
Title of study
Re-induction of a systemic immune response after initial response with immune therapy with radiotherapy in metastatic or locally recurrent lung cancer
Version Number
Approval Date 
3, 8 April 2019
Short Title
Re-Induction
Study site
Principle Investigator
Prof. Dr. D. De Ruysscher
Investigator Maastro
Sponsor
Maastro
Trial registry
Objectives 

Primary:
• To investigate the progression-free survival (PFS) after radiotherapy to a single, progressing lesion in patients with stage IV non-small cell lung cancer (NSCLC) who achieved at least a partial remission with immune therapy and who subsequently show disease progression. The same immune therapy will be continued.
Secundary:
• To investigate whether, based on a pre-treatment blood sample, the overall survival (OS) and the PFS can be predicted.
• To investigate the remission rate (RECIST 1.1) of the irradiated lesion
• To investigate the remission rate (RECIST 1.1) of the non-irradiated lesion(s)
• To investigate the toxicity of this combination.
• Biobanking for later translational research
• To investigate whether the anticancer immune response can be monitored on blood samples

Primary Endpoint 

Progression-free survival (PFS)

Secondary Endpoints 

• To investigate whether, based on a pre-treatment blood sample, the overall survival (OS) and the PFS can be predicted.
• Overall remission rate (RECIST 1.0) of the irradiated lesion at 3 months
• Overall remission rate (RECIST 1.1) of the non-irradiated lesion(s) at 3 months
• Toxicity according to CTCAE 4.0
• Overall survival
• Immune response to combined radio/immunotherapy (blood-based)
• Biobanking for later translational research