Overview

Durvalumab Maintenance After Thoracic Chemoradiotherapy in Frail Small Cell Lung Cancer Patients Whose Disease is Limited to the Thorax

Status:
Not yet recruiting

Trial end date:
2028-11-15

Target enrollment:

Participant gender:

Summary

This study is an academic-lead, open-label, multicenter, randomized phase II trial for frail limited disease Small Cell Lung Cancer (LD-SCLC) patients. Frail conditions are: Eastern Cooperative Oncology Group performance status (ECOG PS) 2 or ECOG PS 0-1 and older than 70 or ECOG PS 0-1 and did not receive a concomitant thoracic chemo-radiotherapy (CRT) because of comorbidities. During the screening phase, patients complete either the standard concomitant thoracic CRT and cisplatin-etoposide regimen or a sequential CRT and carboplatin. Patients showing a disease control (defined as stable disease [SD], partial response [PR], or complete response [CR] according to RECIST v1.1) at the radiological evaluation performed after the end of thoracic CRT can receive prophylactic cranial irradiation (PCI) as per local practice. They will then be randomized to receive durvalumab every 4 weeks (experimental arm A) or surveillance (control arm B) as per standard of care. Thus, DURVALUNG study aims to evaluate the efficacy of durvalumab maintenance treatment in frail LD-SCLC patients who have not progressed following platinum-based concomitant or sequential CRT.

Phase:

Phase 2

Details

Lead Sponsor:

UNICANCER

Collaborator:

AstraZeneca

Treatments:

Durvalumab