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Brief Title: Durvalumab(MEDI4736) After chemoRadioTherapy(DART) for NSCLC-a Translational and Biomarker Study
Official Title: Durvalumab (MEDI4736) After chemoRadioTherapy (DART) for NSCLC Patients - a Phase II Translational and Biomarker Study Investigating PDL1 Positive and Negative Patients
Study ID: NCT04392505
Brief Summary: The main aim is to identify and describe biomarkers in different sample types related to chemoradiation followed by durvalumab treatment for stage III PD-L1 negative and positive non-small cell lung cancer (NSCLC) patients' eligible for curatively intended chemoradiation. The hypothesis is that clinical differences in course of disease reflect underlying biological characteristics.
Detailed Description: This is an open, multinational, phase 2 trial to investigate the Properties of cancer cells before, during and after treatment with the investigational study drug durvalumab in patients with locally advanced non-small celled lung cancer (NSCLC). Both patients with high and low PD-L1 expression are allowed to participate. Durvalumab (PD-L1 inhibitor) will be administered after a period with standardtreatment with chemotherapy and radiationtherapy (chemoradiotherapy) for around 7 weeks. After maximum 5 weeks break after chemoradiotherapy, durvalumab will be given in the same dose to all patients for up to 12 months. The follow-up include a safety follow-up for up to five years, followed by a survival follow-up for up to a total of ten years. The main aim is to identify and describe biomarkers in different sample types related to chemoradiation followed by durvalumab treatment for stage III PD-L1 negative and positive non-small cell lung cancer (NSCLC) patients' eligible for curatively intended chemoradiation. The hypothesis is that clinical differences in course of disease reflect underlying biological characteristics.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
North Estonia Medical Centre, Tallinn, , Estonia
Oulu University Hospital, Oulu, , Finland
Tampere University Hospital, Tampere, , Finland
Turku University Hospital, Turku, , Finland
National Cancer Institute, Vilnius, , Lithuania
Haukeland universitetssykehus, Bergen, , Norway
Oslo University Hospital, Oslo, , Norway
Stavanger University Hospital, Stavanger, , Norway
Universitetssykehuset i Nord-Norge, Tromsø, , Norway
St. Olavs Hospital, Trondheim, , Norway
Name: Åslaug Helland, Prof, MD
Affiliation: Oslo University Hospital
Role: PRINCIPAL_INVESTIGATOR