Atezolizumab in Large Cell Neuroendocrine Carcinoma

Sponsor
Oncology Center of Biochemical Education And Research
Study ID
NCT06049966
Phase
PHASE1
Status
Completed

Conditions

  • Large Cell Neuroendocrine Carcinoma of the Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • Atezolizumab — DRUG
    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.
  • Carboplatin — DRUG
    SOL.INF 450MG/45ML VIAL ΒΤx1VIALx45ML
  • Etoposide — DRUG
    ETOPOSIDE/PHARMACHEMIE SOL.INF 100MG/5ML VIAL BT x 10 VIALS x 5 ML

Study Details

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.

Key Dates

First listed
Sep 22, 2023
Start date
Nov 1, 2019
Status verified
Jul 2026
Primary completion
Sep 1, 2025
Completion
Sep 1, 2025

Study Design

Enrollment
22 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Carboplatin AUC 5 on day 1 plus etoposide 100 mg/m² on days 1-3 every 21 days for 4-6 cycles, with atezolizumab 1200 mg every 21 days. Patients without disease progression after induction therapy continued atezolizumab maintenance for a maximum duration of 24 months, or until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision, whichever occurred first.
  • Active Comparator: Arm B
    Carboplatin AUC 5 on day 1 plus etoposide 100 mg/m² on days 1-3 every 21 days for 4-6 cycles, followed by observation. Subsequent treatment at disease progression was administered according to standard-of-care practice and physician judgment.

Primary Outcome Measure

Progression-free survival [ Time Frame: From treatment initiation through study completion/data cut-off, assessed up to 70 months. ]

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