OncoMatch/Clinical Trials/NCT05617963
Durvalumab Maintenance After Thoracic Chemoradiotherapy in Frail Small Cell Lung Cancer Patients Whose Disease is Limited to the Thorax
Is NCT05617963 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Durvalumab for small cell lung carcinoma.
Treatment: Durvalumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Disease stage
Required: Stage T0-T4, N0-N3 (TNM 8th edition or VALSG 2-stage classification)
Limited disease (T0-T4, N0-N3 and M0) according to the TNM classification 8th edition or to the VALSG 2-stage classification
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: thoracic chemoradiotherapy (cisplatin-etoposide, carboplatin-etoposide) — concomitant or sequential
Patients must have completed concomitant or sequential thoracic CRT by IMRT: at least 60 Gy (one-daily fraction of 1.8-2 Gy) or 45 Gy twice daily (1.5 Gy per fraction) combined with cisplatin-etoposide regimen or with carboplatin AUC5 to AUC6 etoposide regimen.
Lab requirements
Blood counts
Haemoglobin >9 g/dL; Platelet count >100 x 10⁹/L; Neutrophil count >1.5 x 10⁹/L
Kidney function
creatinine clearance ≥40 ml/min calculated with the Cockcroft-Gault formula
Liver function
Total bilirubin <1.5 ULN; AST and ALT <2.5 ULN; Alkaline phosphatase <2.5 ULN
Adequate haematological function: Haemoglobin >9 g/dL; Platelet count >100 x 10⁹/L; Neutrophil count >1.5 x 10⁹/L. Adequate renal function with a creatinine clearance ≥40 ml/min. Adequate hepatic function: Total bilirubin <1.5 ULN; AST and ALT <2.5 ULN; Alkaline phosphatase <2.5 ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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