Overview

A Study Comparing Immunotherapy With Chemotherapy in the Treatment of Elderly Patients With Advanced NSCLC (MILES-5)

Status:
Recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
Summary
This is a randomized phase 2 trial aiming to assess the early efficacy of two experimental treatment sequences. Three arms are planned; (i) standard chemotherapy followed at progression by single agent immunotherapy with durvalumab (CT), (ii) experimental single agent immunotherapy with durvalumab followed at progression by chemotherapy, (iii) experimental combination immunotherapy with durvalumab+tremelimumab followed at progression by chemotherapy. The the two experimental strategies will be compared with the standard strategy in terms of 12-month overall survival, time considered informative for the type of treatment and disease
Phase:
Phase 2
Details
Lead Sponsor:
National Cancer Institute, Naples
Collaborators:
AstraZeneca
University of Campania "Luigi Vanvitelli"
Treatments:
Antibodies, Monoclonal
Durvalumab
Immunologic Factors
Tremelimumab