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

Part of paid clinical trials in New York, New York.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04631029
Phase
PHASE1
Status
Completed

Conditions

  • Extensive Stage Lung Small Cell Carcinoma
  • Malignant Solid Neoplasm
  • Metastatic Malignant Neoplasm in the Brain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — BIOLOGICAL
    Given IV
  • Carboplatin — DRUG
    Given IV
  • Entinostat — DRUG
    Given PO
  • Etoposide — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Apr 27, 2021
Status verified
Sep 2025
Primary completion
Dec 30, 2021
Completion
Jul 11, 2023

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (carboplatin, etoposide, atezolizumab, entinostat)
    INDUCTION THERAPY: Patients receive carboplatin IV over 30-60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, atezolizumab IV over 30-60 minutes on day 1, and entinostat PO on days 1, 8, and 15. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive atezolizumab IV over 30 minutes on day 1 and entinostat PO on days 1, 8, and 15. Treatment repeats every 21 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities [ Time Frame: Up to 21 days ]

Locations (5)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112-
University of Virginia Cancer CenterCharlottesvilleVirginia22908-
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792-

Find similar trials in New York, NY

By research site
Memorial Sloan Kettering Cancer Center· New York, NYUniversity of Pittsburgh Cancer Institute (UPCI)· Pittsburgh, PAHuntsman Cancer Institute/University of Utah· Salt Lake City, UTUniversity of Virginia Cancer Center· Charlottesville, VAUniversity of Wisconsin Carbone Cancer Center· Madison, WI

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