NCT05191797

Bomedemstat and Maintenance Immunotherapy for Treatment of Newly Diagnosed Extensive Stage Small Cell Lung Cancer

A Phase I/II Study of Bomedemstat Combined With Maintenance Immunotherapy for Patients With Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects of bomedemstat and maintenance immunotherapy with atezolizumab and to see how well they work in treating patients with newly diagnosed extensive stage small cell lung cancer. Bomedemstat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving bomedemstat and atezolizumab may work better in treating patients with extensive stage small cell lung cancer.

Detailed description

OUTLINE: Patients receive bomedemstat orally (PO) once daily (QD) on days 1-21 and atezolizumab intravenously (IV) on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 12 weeks thereafter.

Conditions

• Extensive Stage Lung Small Cell Carcinoma
• Limited Stage Lung Small Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Bomedemstat	Given PO
BIOLOGICAL	Atezolizumab	Given IV

Timeline

• Start date: 2022-04-11
• Primary completion: 2023-08-03
• Completion: 2024-04-05
• First posted: 2022-01-14
• Last updated: 2024-09-26
• Results posted: 2024-09-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study