A phase 1b open label study of safety and tolerability in patients treated with stereotactic radiotherapy (to the primary tumor) combined with durvalumab (MEDI4736) and tremelimumab in patients with stage 4 non-small cell lung cancer
- Conditions
- on-small cell lung cancer<br />NSCLC<br />Niet-kleincellig longkanker
- Registration Number
- NL-OMON26168
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
Written informed consent
-Histologically confirmed stage IIIB (without curative treatment options) and stage IV NSCLC. Tumor mutation status must be known, analyzed by next generation sequencing for specific mutations.
Exclusion Criteria
-Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
-Participation in another clinical study with an investigational product during the last 3 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Establishing MTD in 3 sequential combination immunotherapy - radiotherapy cohorts. Percentage of grade III/IV toxicities determined between first radiotherapy day and 8 weeks after combination treatment.
- Secondary Outcome Measures
Name Time Method All AEs, PFS, OS, response rate, T cell immune response (intracellular production of IL-2, IFN-¦Ã, TNF-¦Á and IL-4 by CD4+ en CD8+ T cells to 6 different stimuli).