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

NCT06418087 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2024-05-16

No results posted yet for this study

Summary

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

Conditions

  • Pulmonary Large-cell Neuroendocrine Carcinoma

Interventions

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.

Sponsors & Collaborators

  • Gruppo Oncologico Italiano di Ricerca Clinica

    lead OTHER

Principal Investigators

  • Andrea Ardizzoni · Gruppo Oncologico Italiano di Ricerca Clinica

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-27
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06418087 on ClinicalTrials.gov