Testing the Addition of an Anti-cancer Drug, Entinostat, to the Usual Chemotherapy and Immunotherapy Treatment (Atezolizumab, Carboplatin and Etoposide) for Previously Untreated Aggressive Lung Cancer That Has Spread
NCT04631029 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2025-10-03
Summary
This phase I trial seeks to find out the best dose, possible benefits and/or side effects of entinostat in combination with atezolizumab, carboplatin and etoposide for the treatment of previously untreated aggressive lung cancer that has spread (extensive-stage small cell lung cancer). Entinostat and etoposide 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. Carboplatin is a chemotherapy drug that attaches to deoxyribonucleic acid (DNA) and may kill tumor cells. Giving entinostat in combination with atezolizumab, carboplatin and etoposide may work better than atezolizumab, carboplatin and etoposide alone.
Conditions
- Extensive Stage Lung Small Cell Carcinoma
- Malignant Solid Neoplasm
- Metastatic Malignant Neoplasm in the Brain
Interventions
- BIOLOGICAL
-
Given IV
- DRUG
-
Given IV
- DRUG
-
Entinostat
Given PO
- DRUG
-
Etoposide
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Ryan D Gentzler · JHU Sidney Kimmel Comprehensive Cancer Center LAO
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-27
- Primary Completion
- 2021-12-30
- Completion
- 2023-07-11
- FDA Drug
- Yes
Countries
- United States
Study Locations
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