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Chemo-immunotherapy, Hypo-fractionated RT and Maintenance Immunotherapy for Stage III NSCLC. — DEDALUS  

NSCLC, Stage III Clinical Trial

Official title:
An Open-label, Multi-center, Phase 2 Study of Chemo-immunotherapy Followed by Reduced-dose Hypo-fractionated RT and Maintenance Immunotherapy for Stage III Unresectable Non -Small-cell Lung Carcinoma (NSCLC).

Clinical Trial Summary

Aim of this phase 2 study is to evaluate the safety and the efficacy of the combination of induction chemotherapy plus durvalumab followed by reduced-dose hypo-fractionated thoracic RT (concurrent with durvalumab) and durvalumab maintenance for stage 3 unresectable NSCLC patients candidate to sequential chemo-RT.

Clinical Trial Description

The study hypothesis is that the new regimen tested in this study will be safe and effective by: 1. anticipating the use of durvalumab, together with chemotherapy (higher efficacy) 2. harnessing response to induction chemo-durvalumab (which is expected to be significant) to be able to reduce radiotherapy dose without reducing tumor control probability 3. reducing radiation-induced immunosuppression 4. reducing radiation-induced late morbidity, this aspect is important when considering that this regimen is expected to be able to cure a proportion of patients (long-term survivors) In this phase II study, the investigators will evaluate the combination of induction chemotherapy plus durvalumab followed by reduced-dose hypo-fractionated thoracic RT (concurrent with durvalumab) and durvalumab maintenance for stage 3 unresectable NSCLC patients candidate to sequential chemo-RT. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05128630
Study type Interventional
Source IRCCS Policlinico S. Matteo
Contact Alessandra Ferrari, dr.
Phone +390382503689
Email alessandra.ferrari@smatteo.pv.it
Status Recruiting
Phase Phase 2
Start date October 28, 2021
Completion date November 28, 2025
View Details
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