NCT06049966CompletedPhase 1

Atezolizumab in Large Cell Neuroendocrine Carcinoma

Effectiveness of Atezolizumab in Large Cell Neuroendocrine Carcinoma of the Lung and the Value of miR21 and miR-375 as Biomarkers

Source: ClinicalTrials.gov · Last updated 8 Jul 2026

Brief summary (registry, in English)

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.

Status (registry): Completed
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 22 (actual)
First submitted: 10 Sept 2023
Start date: 1 Nov 2019
Primary completion date: 1 Sept 2025
Lead sponsor: Oncology Center of Biochemical Education And Research
Diseases: Neuroendocrine tumours, Lung cancer
NCT number: NCT06049966

What you commit to

Study type: Interventional · Phase 1
Participants enrolled: 22
From 1 Nov 2019 to the primary completion date, 1 Sept 2025
3 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Prior treatment with chemotherapy, immunotherapy, targeted small molecule therapy, or radiation therapy (except WBRT for brain metastasis from LCNEC)
Treatment with systemic immunosuppressive medications with the following exceptions:
- Patients who have received acute, low-dose systemic immunosuppressant medication (≤ 10 mg/day oral prednisone or equivalent) or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Medical Monitor approval has been obtained.
Major surgical procedure other than for diagnosis within 4 weeks before initiation of study treatment, or anticipation of need for a major surgical procedure during the study
Treatment with any other investigational agent or participation in another clinical study with therapeutic intent

Other illness

Active or history of autoimmune disease or immune deficiency
Active malignancy or malignancy within 3 years
Active tuberculosis
Current severe, uncontrolled systemic disease other than cancer
Known clinically significant liver disease

Who the study is looking for

Histologically confirmed Stage IV (metastatic) or unresectable locally advanced LCNEC
No prior treatment
With or without brain metastasis, if symptomatic patients should be treated with WBRT first
Performance Status ≤ 2
Life expectancy \> 3 months
Written informed consent
Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Criteria the registry did not label

Cohorts A and B:

Age in the registry: 18 years to 90 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Save your city in your profile to sort them by distance.

Site	City	Country	Site status
"Sotiria" Thoracic Diseases General Hospital of Athens Coordinator of this site? Confirm its status	Athens	Greece	Unknown status
OCEBER Coordinator of this site? Confirm its status	Athens	Greece	Unknown status
National and Kapodistrian University of Athens Coordinator of this site? Confirm its status	Athens	Greece	Unknown status

Related publications

Development of an externally controlled trial from a single-arm study to assess first-line immunochemotherapy in advanced large cell neuroendocrine lung carcinomas: a study protocol from the FIRST-NEC GFPC 01-2022 trial.BMJ Open · 2026 · PMID 42526918

This page is information, not medical advice. Discuss any trial with your doctor.