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Thoracic Radiotherapy Plus Durvalumab in Elderly and/or Frail NSCLC Stage III Patients Unfit for Chemotherapy — TRADE-hypo  

NSCLC, Stage III Clinical Trial

Official title:
Thoracic Radiotherapy Plus Durvalumab in Elderly and/or Frail NSCLC Stage III Patients Unfit for Chemotherapy - Employing Optimized (Hypofractionated) Radiotherapy to Foster Durvalumab Efficacy

Clinical Trial Summary

This is a randomized, open-label, multicenter, phase II trial investigating the combination of thoracic radiotherapy plus Durvalumab in patients with locally advanced, unresectable NSCLC (stage III) that are unfit for chemotherapy (e.g. due to age and/or frailty).

Clinical Trial Description

This trial investigates the feasibility and treatment efficacy when combining durvalumab treatment with either conventionally fractionated (CON-group) or hypofractionated thoracic radiotherapy (HYPO-group) in previously untreated NSCLC stage III patients prone to radiotherapy only. A safety lead-in phase with stop-and-go design will precede full enrollment into the HYPO-group. Tumor tissue as well as blood and stool samples will be collected for future biomarker analysis. It is hypothesized that TRT combined with concurrent durvalumab administration in patients with unresectable stage III NSCLC, who are not amenable to sequential radio-/chemotherapy 1. is safe and feasible, 2. will improve treatment efficacy by a synergistic effect of checkpoint inhibition and the photon-induction of immunostimulatory pathways. 3. will have an effect on the immunological characteristics of the tumor, the microenvironment, and the systemic immune response, such as upregulation of PD-L1 or secretion of stimulatory cytokines and recruitment and priming of immunocompetent cells, which might then mediate the "abscopal effect" beyond the irradiated targets. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04351256
Study type Interventional
Source Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Contact Farastuk Bozorgmehr, Dr. med.
Phone +49 6221-396 8077
Email farastuk.bozorgmehr@med.uni-heidelberg.de
Status Recruiting
Phase Phase 2
Start date May 20, 2020
Completion date June 30, 2026
View Details
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