Trial · NCT04631029
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, Phase 1, Completed, National Cancer Institute (NCI); results first posted 2023-06-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT04631029. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04631029
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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 number
- NCT04631029
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 3 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Extensive Stage Lung Small Cell Carcinoma, Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Brain
- Interventions
- Atezolizumab, Carboplatin, Entinostat, Etoposide
- First posted
- 2020-11-17
- Last updated
- 2025-10-03
- Results first posted
- 2023-06-27
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities | Up to 21 days | The Bayesian optimal interval (BOIN) design will be used to find the MTD based on safety as determined by dose limiting toxicities. |
| Primary | Number of Participants Experiencing Grade 3 and 4 Adverse Events | Up to 30 days | Defined by Common Terminology Criteria for Adverse Events version 5.0. Will be summarized by frequency and magnitude. |
| Primary | Number of Participants Who Received 3 or More Cycles of the Combination of Entinostat, Atezolizumab, Carboplatin, and Etoposide | 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. |
| Secondary | Progression Free Survival (PFS) Rate | Up to 2 months | Defined 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose Limiting Toxicities | Up to 21 days | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants Experiencing Grade 3 and 4 Adverse Events | Up to 30 days | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants Who Received 3 or More Cycles of the Combination of Entinostat, Atezolizumab, Carboplatin, and Etoposide | Up to cycle 4 (1 cycle = 21 days) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression Free Survival (PFS) Rate | Up to 2 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicities | Dose Level 1 | Completed Dose Level 1 without a dose-limiting toxicity | 1 | Participants | |
| Number of Participants With Dose Limiting Toxicities | Dose Level 1 | Experienced a dose limiting toxicity in Dose Level 1 | 2 | Participants | |
| Number of Participants Experiencing Grade 3 and 4 Adverse Events | Dose Level 1 | Grade 3 Adverse Events | 3 | Participants | |
| Number of Participants Experiencing Grade 3 and 4 Adverse Events | Dose Level 1 | Grade 4 Adverse Events | 2 | Participants | |
| Number of Participants Who Received 3 or More Cycles of the Combination of Entinostat, Atezolizumab, Carboplatin, and Etoposide | Dose Level 1 | Received 3 or more cycles | 0 | Participants | |
| Number of Participants Who Received 3 or More Cycles of the Combination of Entinostat, Atezolizumab, Carboplatin, and Etoposide | Dose Level 1 | Received 1 or 2 cycles | 3 | Participants | |
| Progression Free Survival (PFS) Rate | Dose Level 1 | Alive without Disease Progression | 0 | Participants | |
| Progression Free Survival (PFS) Rate | Dose Level 1 | Deceased by 2 months | 1 | Participants | |
| Progression Free Survival (PFS) Rate | Dose Level 1 | Withdrew by 2 months | 2 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Level 1 | 3 | |
| Overall Study | COMPLETED | Dose Level 1 | 3 | |
| Overall Study | NOT COMPLETED | Dose Level 1 | 0 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Activated partial thromboplastin time prolonged | Investigations | Dose Level 1 | 1 | 3 | |
| other | Anemia | Blood and lymphatic system disorders | Dose Level 1 | 3 | 3 | |
| other | Atrial fibrillation | Cardiac disorders | Dose Level 1 | 1 | 3 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Dose Level 1 | 1 | 3 | |
| other | Creatine kinase increased | Investigations | Dose Level 1 | 1 | 3 | |
| other | Creatinine increased | Investigations | Dose Level 1 | 1 | 3 | |
| other | Dehydration | Metabolism and nutrition disorders | Dose Level 1 | 1 | 3 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Dose Level 1 | 1 | 3 | |
| other | Gastroesophageal reflux disease (GERD) | Gastrointestinal disorders | Dose Level 1 | 1 | 3 | |
| other | Hypertension | Vascular disorders | Dose Level 1 | 2 | 3 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level 1 | 1 | 3 |
| Total, other adverse events | Dose Level 1 | 3 | 3 |
| Total, serious adverse events | Dose Level 1 | 3 | 3 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37555284 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA186691 | The Johns Hopkins Translational Science Team and Consortium for ETCTN Studies | CARDUCCI, MICHAEL A; BEUMER, JAN HENDRIK; GENTZLER, RYAN; LIU, GLENN; MESSERSMITH, WELLS A.; RUIZ, JIMMY | JOHNS HOPKINS UNIVERSITY | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04631029
GET https://conductscience.org/api/trials/v1/NCT04631029/events?page=2