NCT06418087

Durvalumab With Carboplatin and Etoposide Chemotherapy in Pulmonary Large-cell Neuroendocrine Carcinoma (LCNEC)

A Multicenter Phase II, Single Arm Study of Durvalumab (MEDI 4736) With Carboplatin Plus Etoposide for 4 Cycles Followed by Durvalumab Maintenance in Patients With Metastatic Pulmonary Large-cell Neuroendocrine Carcinoma (LCNEC)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective multicenter, single-arm phase II study enrolling treatment-naïve patients with metastatic pulmonary large-cell neuroendocrine carcinoma (LCNEC)

Detailed description

This is a prospective multicenter, single-arm phase II study enrolling treatment-naïve patients with metastatic pulmonary large-cell neuroendocrine carcinoma (LCNEC). Enrolled subjects will receive a combination of intravenous carboplatin (AUC 5 on day 1), etoposide (100 mg/sqm on days 1-3), and durvalumab (1500 mg on day 1) administered every three weeks for a total of 4 courses (induction phase) or until progression of disease, unacceptable toxicity, patient refusal or loss of clinical benefit. Treatment with intravenous durvalumab (1500 mg on day 1) every 4 weeks (maintenance phase) will continue until completion of 24 courses (for a total of 28 courses, including the 4 courses of induction phase) or 2 years of treatment whichever occurs first, disease progression, unacceptable toxicity, patient refusal or loss of clinical benefit.

Conditions

• Pulmonary Large-cell Neuroendocrine Carcinoma

Interventions

Type	Name	Description
DRUG	Durvalumab 50 MG/1 ML Intravenous Solution [IMFINZI]	Intravenous infusion of durvalumab 1500 mg on day 1 (induction phase) with carboplatin (AUC 5 on day 1), etoposide (100 mg/sqm on days 1-3) every 3 weeks, and durvalumab (1500 mg on day 1) administered every three weeks for up to 4 cycles (induction phase) or until progression of disease, unacceptable toxicity, patient refusal or loss of clinical benefit (for durvalumab). Treatment with intravenous durvalumab (1500 mg on day 1) every 4 weeks ± 3 days (maintenance phase) will continue until completion of 24 courses (for a total of 28 courses, including the 4 courses of induction phase) or 2 years of treatment whichever occurs first, disease progression, unacceptable toxicity, patient refusal or loss of clinical benefit.

Timeline

• Start date: 2022-05-27
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-05-16
• Last updated: 2024-05-16

Locations

15 sites across 1 country: Italy