Ablative STEreotactic RadiOtherapy wIth Durvalumab (MEDI4736). An Open Label Randomized Phase II Trial With Durvalumab Following Stereotactic Body Radiotherapy (SBRT) in Patients With Stage I Non-small Cell Lung Cancer (NSCLC)
This is a randomized multicentre open label phase II study of Durvalumab following Stereotactic Body Radiotherapy (SBRT) in patients with T1-2N0M0 NSCLC. Patients will be randomized 1:1 to follow up or receiving Durvalumab every 4th week for 12 months
• Written informed consent obtained from the subject prior to performing any protocol- related procedures, including screening evaluations
• Histological or cytological diagnosis of NSCLC
• Stage I-IIA tumours ≤ 5 cm
• Peripheral tumours
• Medically inoperable patients or patients refusing surgery
• Received no prior chemotherapy or radiation therapy for NSCLC
• Age \> 18 years at time of study entry, no upper age limit
• WHO performance status 0-2
• Adequate normal organ and marrow function as defined below:
• Haemoglobin ≥ 9.0 g/dL
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (\> 1500 per mm3)
• Platelet count ≥ 100 x 109/L (\>100,000 per mm3)
• Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
• AST/ALT ≤ 2.5 x institutional upper limit of normal
• Serum creatinine CL\>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by chrome-EDTA or Iohexol clearance
• Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal subjects
• Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up