Atezolizumab in Large Cell Neuroendocrine Carcinoma

NCT06049966 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-07-08

No results posted yet for this study

Summary

Large-cell neuroendocrine carcinoma (LCNEC) of the lung is a rare and aggressive malignancy with limited prospective evidence to guide systemic treatment. This prospective, non-randomized, real-world study evaluated the effectiveness and safety of atezolizumab in combination with platinum-etoposide chemotherapy in treatment-naïve patients with metastatic lung-derived LCNEC.

Patients who received atezolizumab were treated with carboplatin, etoposide, and atezolizumab, followed by atezolizumab maintenance in patients without disease progression for up to 24 months, or until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision, whichever occurred first. Patients in the control cohort received carboplatin and etoposide alone.

The main clinical outcomes were progression-free survival, overall survival, overall response rate, and duration of response. Exploratory translational analyses included plasma microRNA assessment, including miR-375 and miR-21, in available blood samples.

Conditions

  • Large Cell Neuroendocrine Carcinoma of the Lung

Interventions

DRUG

Atezolizumab

Atezolizumab 1200 mg intravenously every 21 days, administered with platinum-etoposide induction and continued as maintenance in non-progressing patients for up to 24 months, or until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision, whichever occurred first.

DRUG

Carboplatin

SOL.INF 450MG/45ML VIAL ΒΤx1VIALx45ML

DRUG

Etoposide

ETOPOSIDE/PHARMACHEMIE SOL.INF 100MG/5ML VIAL BT x 10 VIALS x 5 ML

Sponsors & Collaborators

  • Oncology Center of Biochemical Education And Research

    lead OTHER

Principal Investigators

  • Konstantinos N Syrigos · National and Kapodistrian University of Athens

  • Georgios Evangelou · National and Kapodistrian University of Athens

  • Konstantinos N Syrigos · Konstantinos

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2025-09-01
Completion
2025-09-01
FDA Drug
Yes

Countries

  • Greece

Study Locations

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Entities

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 NCT06049966 on ClinicalTrials.gov