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)

Who is this study for? Patients with stage I non-small cell lung cancer
What treatments are being studied? Durvalumab
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Finland
Helsinki
RECRUITING
Helsinki
Dept of Oncology
RECRUITING
Tampere
Turku
RECRUITING
Turku
Dept of Oncology
RECRUITING
Vaasa
Norway
Ålesund
RECRUITING
Ålesund
Dept of Oncology
RECRUITING
Oslo
Dept of pulmonary medicine
RECRUITING
Tromsø
Dept of Oncology
RECRUITING
Trondheim
Sweden
Dept of pulmonary medicine
RECRUITING
Gävle
Dept. of Oncology
RECRUITING
Gothenburg
Dept of pulmonary medicine
RECRUITING
Linköping
Sunderbyn
RECRUITING
Luleå
Dept of pulmonary medicine
RECRUITING
Lund
Dept of Oncology
RECRUITING
Stockholm
Dept. of Oncology
RECRUITING
Umeå
Contact Information
Primary
Andreas Hallqvist, PhD
andreas.hallqvist@vgregion.se
+46-31342
Backup
Annika Baan
annika.baan@vgregion.se
+46-70
Time Frame
Start Date: 2017-12-04
Estimated Completion Date: 2024-07
Participants
Target number of participants: 106
Treatments
No_intervention: Arm A
SBRT and follow-up
Experimental: Arm B
SBRT followed by Durvalumab
Sponsors
Leads: Vastra Gotaland Region
Collaborators: AstraZeneca

This content was sourced from clinicaltrials.gov

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