Status:
COMPLETED
Atezolizumab in Large Cell Neuroendocrine Carcinoma
Lead Sponsor:
Oncology Center of Biochemical Education And Research
Conditions:
Large Cell Neuroendocrine Carcinoma of the Lung
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
This trial is a prospective clinical study to evaluate the effectiveness of a combination treatment regimen for patients with metastatic Large Cell Neuroendocrine Carcinoma (LCNEC) originating from th...
Eligibility Criteria
Inclusion
- Cohorts A and B:
- 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
Exclusion
- Prior treatment with chemotherapy, immunotherapy, targeted small molecule therapy, or radiation therapy (except WBRT for brain metastasis from LCNEC)
- Active or history of autoimmune disease or immune deficiency
- 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
- Active malignancy or malignancy within 3 years
- Active tuberculosis
- Current severe, uncontrolled systemic disease other than cancer
- Known clinically significant liver disease
- Treatment with any other investigational agent or participation in another clinical study with therapeutic intent
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06049966
Start Date
March 1 2018
End Date
May 1 2023
Last Update
September 22 2023
Active Locations (2)
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1
National and Kapodistrian University of Athens
Athens, Greece, 11527
2
OCEBER
Athens, Greece, 11527