Atezolizumab in Large Cell Neuroendocrine Carcinoma

NCT06049966 | Completed Phase 1 FDA Drug

• 1 other identifier: UPI-2023-2304
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Large Cell Neuroendocrine Carcinoma of the Lung

Keywords

Atezolizumab; Immunotherapy; LCNEC; Large Cell Neuroendocrine Carcinoma; Immune Checkpoint Inhibitors; miR375

Outcome Measures

Primary Outcomes (2)

• Progression-free survival

  Progression Free Survival (PFS) was defined as the time from treatment initiation to disease progression οr death. Patients alive without progression at the last follow-up were censored at the date of the deadline for follow-up

  Through study completion, an average of 3 years

• Overall survival

  Overall survival (OS) was defined as the time from treatment initiation to death, and patients alive during the last follow-up were censored at the date of the deadline for follow-up

  Through study completion, an average of 3 years

Study Arms (2)

Arm A

EXPERIMENTAL

Carboplatin 5 AUC D1 plus Etoposide 100mg/m2 D1-D3 plus Atezolizumab 1200 mg, Q21, 4 Cycles and then maintenance Atezolizumab 1200 mg Q21

Drug: Atezolizumab; Drug: Carboplatin; Drug: Etoposide

Arm B

ACTIVE COMPARATOR

Carboplatin 5 AUC D1 plus Etoposide 100mg/m2 D1-D3, 4 Cycles and then observation

Drug: Carboplatin; Drug: Etoposide

Interventions

Atezolizumab DRUG

TECENTRIQ C/S.SOL.IN 1200MG/VIAL (20ML) 1 VIAL x 20ML

Also known as: Tecentriq

Arm A

Carboplatin DRUG

SOL.INF 450MG/45ML VIAL ΒΤx1VIALx45ML

Also known as: CARBOPLATIN/HOSPIRA

Arm A; Arm B

Etoposide DRUG

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

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oncology Center of Biochemical Education And Research: lead

Study Sites (2)

National and Kapodistrian University of Athens

Athens, 11527, Greece

Location

OCEBER

Athens, 11527, Greece

Location

MeSH Terms

Interventions

atezolizumab; Carboplatin; Etoposide

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Konstantinos N Syrigos

  National and Kapodistrian University of Athens

  STUDY CHAIR

• Georgios Evangelou

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

• Konstantinos N Syrigos

  Konstantinos

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2023
• First Posted: September 22, 2023
• Study Start: March 1, 2018
• Primary Completion: August 1, 2022
• Study Completion: May 1, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

GR (2)