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

NCT05617963 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-23

No results posted yet for this study

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 or sequential thoracic CRT and cisplatin-etoposide regimen or carboplatin AUC5 to AUC6 etoposide regimen.

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 treated by durvalumab every 4 weeks.

DURVALUNG study aims to evaluate the activity of durvalumab maintenance treatment in frail LD-SCLC patients who have not progressed following platinum-based concomitant or sequential CRT.

Conditions

  • Small Cell Lung Carcinoma

Interventions

DRUG

Durvalumab

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 will receive durvalumab intravenously 1500 mg every 4 weeks until disease progression, unacceptable toxicity, death or patient's decision for a maximum of 24 months.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Principal Investigators

  • Elisa GOBBINI, MD · Institut Curie Paris

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-24
Primary Completion
2028-02-24
Completion
2030-02-24

Countries

  • France

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05617963 on ClinicalTrials.gov