Trial Outcomes & Findings for 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 (NCT NCT04631029)
NCT ID: NCT04631029
Last Updated: 2025-10-03
Results Overview
The Bayesian optimal interval (BOIN) design will be used to find the MTD based on safety as determined by dose limiting toxicities.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
3 participants
Primary outcome timeframe
Up to 21 days
Results posted on
2025-10-03
Participant Flow
Participant milestones
| Measure |
Dose Level 1
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 2 mg 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.
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|---|---|
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Overall Study
STARTED
|
3
|
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Overall Study
COMPLETED
|
3
|
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Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=3 Participants
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 2 mg 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.
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|---|---|
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Age, Continuous
|
32 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
|
Disease Stage
Advanced (Stage III) disease
|
1 Participants
n=5 Participants
|
|
Disease Stage
Metastatic (Stage IV) disease
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2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 21 daysThe Bayesian optimal interval (BOIN) design will be used to find the MTD based on safety as determined by dose limiting toxicities.
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
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 2 mg 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.
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|---|---|
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Number of Participants With Dose Limiting Toxicities
Completed Dose Level 1 without a dose-limiting toxicity
|
1 Participants
|
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Number of Participants With Dose Limiting Toxicities
Experienced a dose limiting toxicity in Dose Level 1
|
2 Participants
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PRIMARY outcome
Timeframe: Up to 30 daysDefined by Common Terminology Criteria for Adverse Events version 5.0. Will be summarized by frequency and magnitude.
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
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 2 mg 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.
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|---|---|
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Number of Participants Experiencing Grade 3 and 4 Adverse Events
Grade 3 Adverse Events
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3 Participants
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Number of Participants Experiencing Grade 3 and 4 Adverse Events
Grade 4 Adverse Events
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2 Participants
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PRIMARY outcome
Timeframe: Up to cycle 4 (1 cycle = 21 days)The proportion of participants who received 3 or more cycles of the combination, will be calculated with a 90% confidence interval.
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
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 2 mg 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.
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|---|---|
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Number of Participants Who Received 3 or More Cycles of the Combination of Entinostat, Atezolizumab, Carboplatin, and Etoposide
Received 3 or more cycles
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0 Participants
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Number of Participants Who Received 3 or More Cycles of the Combination of Entinostat, Atezolizumab, Carboplatin, and Etoposide
Received 1 or 2 cycles
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3 Participants
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SECONDARY outcome
Timeframe: Up to 2 monthsDefined as the proportion of patients alive and without disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Will be estimated with a 90% confidence interval. The Kaplan Meier estimator will be used to estimate survival curves.
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
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 2 mg 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.
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|---|---|
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Progression Free Survival (PFS) Rate
Alive without Disease Progression
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0 Participants
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Progression Free Survival (PFS) Rate
Deceased by 2 months
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1 Participants
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Progression Free Survival (PFS) Rate
Withdrew by 2 months
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2 Participants
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Adverse Events
Dose Level 1
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Dose Level 1
n=3 participants at risk
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 2 mg 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.
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|---|---|
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Blood and lymphatic system disorders
Febrile neutropenia
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33.3%
1/3 • Up to 2 months
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Infections and infestations
Lung infection
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33.3%
1/3 • Up to 2 months
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Investigations
Neutrophil count decreased
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66.7%
2/3 • Up to 2 months
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Investigations
Platelet count decreased
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33.3%
1/3 • Up to 2 months
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Infections and infestations
Sepsis
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33.3%
1/3 • Up to 2 months
|
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Gastrointestinal disorders
Typhlitis
|
33.3%
1/3 • Up to 2 months
|
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Investigations
White blood cell count decreased
|
33.3%
1/3 • Up to 2 months
|
Other adverse events
| Measure |
Dose Level 1
n=3 participants at risk
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 2 mg 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.
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|---|---|
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Investigations
Activated partial thromboplastin time prolonged
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33.3%
1/3 • Up to 2 months
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Blood and lymphatic system disorders
Anemia
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100.0%
3/3 • Up to 2 months
|
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Cardiac disorders
Atrial fibrillation
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33.3%
1/3 • Up to 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
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33.3%
1/3 • Up to 2 months
|
|
Investigations
Creatine kinase increased
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33.3%
1/3 • Up to 2 months
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|
Investigations
Creatinine increased
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33.3%
1/3 • Up to 2 months
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Metabolism and nutrition disorders
Dehydration
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33.3%
1/3 • Up to 2 months
|
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Respiratory, thoracic and mediastinal disorders
Dyspnea
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33.3%
1/3 • Up to 2 months
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Gastrointestinal disorders
Gastroesophageal reflux disease (GERD)
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33.3%
1/3 • Up to 2 months
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Vascular disorders
Hypertension
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66.7%
2/3 • Up to 2 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
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66.7%
2/3 • Up to 2 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
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66.7%
2/3 • Up to 2 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
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33.3%
1/3 • Up to 2 months
|
|
Metabolism and nutrition disorders
Hypokalemia
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33.3%
1/3 • Up to 2 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
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33.3%
1/3 • Up to 2 months
|
|
Metabolism and nutrition disorders
Hyponatremia
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33.3%
1/3 • Up to 2 months
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Up to 2 months
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Up to 2 months
|
|
Gastrointestinal disorders
Nausea
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33.3%
1/3 • Up to 2 months
|
|
Investigations
Neutrophil count decreased
|
66.7%
2/3 • Up to 2 months
|
|
Gastrointestinal disorders
Oral pain
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33.3%
1/3 • Up to 2 months
|
|
General disorders
Pain
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33.3%
1/3 • Up to 2 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
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33.3%
1/3 • Up to 2 months
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • Up to 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
33.3%
1/3 • Up to 2 months
|
|
Renal and urinary disorders
Urinary frequency
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33.3%
1/3 • Up to 2 months
|
|
Investigations
White blood cell decreased
|
66.7%
2/3 • Up to 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60