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
    TECENTRIQ C/S.SOL.IN 1200MG/VIAL (20ML) 1 VIAL x 20ML
  • 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) is a rare and aggressive form of cancer that presents significant challenges regarding treatment options and prognosis. In this trial, the effectiveness of Atezolizumab in treating metastatic LCNEC was evaluated. Atezolizumab is an anti-PD-L1 antibody that has shown promising results in other types of cancer, such as small-cell lung Cancer and non-small-cell lung cancer. The trial aimed to assess the efficacy and safety of atezolizumab in combination with chemotherapy as a potential treatment option for treatment-naive patients with metastatic LCNEC The trial was conducted as an open-label, non-randomized study, comparing Atezolizumab plus platinum etoposide to platinum etoposide alone in patients with metastatic LCNEC.

Key Dates

Start date
Mar 1, 2018
Status verified
Sep 2023
Primary completion
Aug 1, 2022
Completion
May 1, 2023

Study Design

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

Arms

  • Experimental: Arm A
    Carboplatin 5 AUC D1 plus Etoposide 100mg/m2 D1-D3 plus Atezolizumab 1200 mg, Q21, 4 Cycles and then maintenance Atezolizumab 1200 mg Q21
  • Active Comparator: Arm B
    Carboplatin 5 AUC D1 plus Etoposide 100mg/m2 D1-D3, 4 Cycles and then observation

Primary Outcome Measure

Progression-free survival [ Time Frame: Through study completion, an average of 3 years ]

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