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
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|ClinicalTrials.gov Identifier: NCT04631029|
Recruitment Status : Recruiting
First Posted : November 17, 2020
Last Update Posted : September 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Extensive Stage Lung Small Cell Carcinoma Malignant Solid Neoplasm Metastatic Malignant Neoplasm in the Brain||Biological: Atezolizumab Drug: Carboplatin Drug: Entinostat Drug: Etoposide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of Entinostat in Combination With Atezolizumab / Carboplatin / Etoposide in Previously Untreated Extensive-Stage Small Cell Lung Cancer|
|Actual Study Start Date :||February 1, 2021|
|Estimated Primary Completion Date :||May 1, 2023|
|Estimated Study Completion Date :||May 1, 2023|
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.
- Maximum tolerated dose (MTD) [ Time Frame: Up to 21 days ]The Bayesian optimal interval (BOIN) design will be used to find the MTD based on safety.
- Grade 3/4 adverse event rate [ Time Frame: Up to 30 days ]Defined by Common Terminology Criteria for Adverse Events version 5.0. Will be summarized by frequency and magnitude.
- Number of cycles received of the combination of entinostat, atezolizumab, carboplatin, and etoposide [ Time Frame: Up to cycle 4 (1 cycle = 21 days) ]The proportion of participants who receive 3 or more cycles of the combination, will be calculated with a 90% confidence interval.
- 9-month progression free survival (PFS) rate [ Time Frame: 9 months from study enrollment ]Defined as the proportion of patients alive and without disease progression. Will be estimated with a 90% confidence interval. The Kaplan Meier estimator will be used to estimate survival curves.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04631029
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Site Public Contact 212-639-7592|
|Principal Investigator: Charles M. Rudin|
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute (UPCI)||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: Site Public Contact 412-647-8073|
|Principal Investigator: Liza C. Villaruz|
|United States, Utah|
|Huntsman Cancer Institute/University of Utah||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|Contact: Site Public Contact 888-424-2100 firstname.lastname@example.org|
|Principal Investigator: Sonam Puri|
|United States, Virginia|
|University of Virginia Cancer Center||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Site Public Contact 434-243-6303 email@example.com|
|Principal Investigator: Ryan D. Gentzler|
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics||Suspended|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Ryan D Gentzler||JHU Sidney Kimmel Comprehensive Cancer Center LAO|