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

Sponsor
UNICANCER
Study ID
NCT05617963
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Small Cell Lung Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 24, 2023
Status verified
Apr 2026
Primary completion
Feb 24, 2028
Completion
Feb 24, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Durvalumab maintenance
    Patients 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. For patients receiving prophylactic cranial irradiation as per standard of care, the first dose of durvalumab may be delayed by up to 42 days from the end of the CRT. Radiological assessments will be planned every 12 weeks (± 7 days) of maintenance treatment. The first dose of durvalumab should be administered within 3 days of inclusion.

Primary Outcome Measure

Progression-free survival [ Time Frame: From inclusion to disease progression or death, up to 3.5 years ]

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