OncoMatch/Clinical Trials/NCT06393816
FIRST-NEC (GFPC 01-2022) - Combination of Durvalumab With Etoposide and Platinum
Is NCT06393816 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Cancer type
Neuroendocrine Tumor
Non-Small Cell Lung Carcinoma
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.
Frequently asked questions
Is NCT06393816 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior PD-1 inhibitor, PD-L1 inhibitor, chemotherapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify