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Brief Title: Thoracic RadiothErapy With Atezolizumab in Small Cell lUng canceR Extensive Disease
Official Title: Thoracic RadiothErapy With Atezolizumab in Small Cell lUng canceR Extensive Disease: a Randomized, Open-label, Multicenter Phase II Study
Study ID: NCT04462276
Brief Summary: This is a multicenter phase 2 clinical trial to investigate the treatment efficacy and feasibility of combining thoracic radiotherapy (TRT) with the IMpower133 regimen in the upfront treatment of ED SCLC patients. Patients with a response after induction therapy with carboplatin/etoposide and atezolizumab will be included into this study to subsequently receive atezolizumab maintenance therapy and will be randomized to receive TRT or not. This trial aims to i.) increase the efficacy of combined atezolizumab- and chemotherapy by adding radiotherapy and ii.) determine the safety and tolerability of the combination of chemotherapeutic, immunological and radiological treatment in the first-line setting of advanced SCLC, and iii.) to collect tumor tissue as well as blood and stool samples for separate biomarker research project.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Kepler Universitätsklinikum, MC III., Pneumologie, Linz, , Austria
Thoraxklinik am Universitätsklinikum Heidelberg, Heidelberg, , Germany
Name: Farastuk Bozorgmehr, Dr. med.
Affiliation: Thoraxklinik at Heidelberg University
Role: PRINCIPAL_INVESTIGATOR