Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418087
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2022-08-11
Brief Title:
Durvalumab With Carboplatin and Etoposide Chemotherapy in Pulmonary Large-cell Neuroendocrine Carcinoma LCNEC
Sponsor:
Gruppo Oncologico Italiano di Ricerca Clinica
Organization:
Gruppo Oncologico Italiano di Ricerca Clinica
Study Overview
Official Title:
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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DUPLE
Brief 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 mgsqm 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None