A Phase II, Single-arm Trial of Atezolizumab/Platinum/Etoposide for the Treatment of Advanced Large-cell Neuroendocrine Cancer of the Lung

Technische Universität Dresden30 sites in 1 country67 target enrollmentJanuary 18, 2022

ConditionsLarge Cell Neuroendocrine Carcinoma of the Lung

InterventionsAtezolizumab

DrugsAtezolizumab

Overview

Phase: Phase 2
Intervention: Atezolizumab
Conditions: Large Cell Neuroendocrine Carcinoma of the Lung
Sponsor: Technische Universität Dresden
Enrollment: 67
Locations: 30
Primary Endpoint: Overall survival
Status: Active, Not Recruiting
Last Updated: 17 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This phase II clinical trial evaluates the efficacy, safety and tolerability of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.

Registry

clinicaltrials.gov

Start Date

January 18, 2022

End Date

January 31, 2029

Last Updated

17 days ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Technische Universität Dresden

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written informed consent
•Patients with locally advanced or metastatic large-cell neuroendocrine carcinoma of the lung (LCNEC) without curative treatment options (patients with mixed histology are eligible if LCNEC is the predominant histology i.e. ≥50%)
•Previously untreated with systemic therapy (note: patients relapsing after curative radio chemotherapy or adjuvant chemotherapy are eligible if relapse occurs ≥6 months after discontinuation of curative treatment)
•Planned treatment with Carboplatin or Cisplatin and Etoposide (SoC)
•ECOG performance status: 0-2
•age ≥18 years
•measurable disease according to RECIST v1.1
•adequate organ function defined as:
•ALAT/ASAT ≤2.5x ULN or ≤3.5x ULN in case of liver metastases
•Bilirubin ≤1.5x ULN or ≤2.5x ULN in case of liver metastases

Exclusion Criteria

•Symptomatic brain metastases (patients with asymptomatic brain metastases are allowed provided they are stable without steroid treatment for at least 3 weeks)
•Severe autoimmune disease (patients with endocrine autoimmune disorders are allowed as long as they are on stable substitution treatment)
•Severe uncontrolled infection
•Prior treatment with either Atezolizumab or other immune checkpoint inhibitor
•Any prior treatment for metastatic disease

Arms & Interventions

Atezolizumab/Platinum/Etoposide

Atezolizumab/Platinum/Etoposide Platinum will be cisplatin or carboplatin at the investigators discretion.

Intervention: Atezolizumab

Outcomes

Primary Outcomes

Overall survival

Time Frame: appr. 72 months

To assess the efficacy of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC as measured by overall survival.

Secondary Outcomes

Disease Control Rate (DCR)(appr. 72 months)
Incidence, intensity, seriousness, relationship to Atezolizumab, and outcome of adverse events graded according to NCI CTCAE (v5.0).(appr. 72 months)
Immune Objective Response Rate (iORR)(appr. 72 months)
Immune Progression Free Survival (iPFS)(appr. 72 months)
Duration of Response (DoR)(appr. 72 months)
Progression Free Survival (PFS)(appr. 72 months)
Progression Free Survival (PFS) rate at one year(1 year)
Immune Progression Free Survival (iPFS) rate at one year(1 year)
Overall survival at one year(1 year)
Objective Response Rate (ORR)(appr. 72 months)