OncoMatch/Clinical Trials/NCT06393816
FIRST-NEC (GFPC 01-2022) - Combination of Durvalumab With Etoposide and Platinum
Is NCT06393816 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Durvalumab with etoposide and Carboplatin/Cisplatin for large cell neuroendocrine carcinoma of the lung.
Treatment: Durvalumab with etoposide and Carboplatin/Cisplatin — The primary objective is to determine the efficacy (Progression-Free Rate at 12 months) of durvalumab combined with etoposide and platinum (either cisplatin or carboplatin) for the first-line treatment of patients with advanced LCNEC confirmed by centralized expert-pathologist review
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: PD-1 inhibitor
Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab
Cannot have received: PD-L1 inhibitor (durvalumab)
Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab
Cannot have received: chemotherapy
Exception: in metastatic setting
Patient previously treated for a LCNEC in a metastatic setting
Lab requirements
Blood counts
Haemoglobin ≥8.0 g/dL (with or without transfusion); Absolute neutrophil count (ANC) ≥1.5 × 10^9 /L; Platelet count ≥100 × 10^9/L
Kidney function
For patients undergoing a treatment by cisplatin: measured creatinine clearance (CrCl) ≥60 mL/min or Calculated creatinine CrCl ≥60 mL/min by the CKD-EPI equation or by 24-hour urine collection for determination of creatinine clearance (CrCl). If creatinine clearance is <60 ml/min, patients must be treated with carboplatin rather than cisplatin.
Liver function
Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN)), or ≤3.0xULN in case of liver metastases. AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN
Cardiac function
Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) <470 ms
Adequate normal organ and marrow function as defined below: Haemoglobin ≥8.0 g/dL (with or without transfusion); Absolute neutrophil count (ANC) ≥1.5 × 10^9 /L; Platelet count ≥100 × 10^9/L; Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN)), or ≤3.0xULN in case of liver metastases. AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN; For patients undergoing a treatment by cisplatin: measured creatinine clearance (CrCl) ≥60 mL/min or Calculated creatinine CrCl ≥60 mL/min by the CKD-EPI equation or by 24-hour urine collection for determination of creatinine clearance (CrCl). Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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