Azacitidine and Entinostat in Treating Patients With Stage I Non-Small Cell Lung Cancer That Has Been Removed By Surgery

Study summary

This study combines the deoxyribonucleic acid (DNA) methyltransferase inhibitor, 5-azacitidine (5-AZA), with an orally bioavailable histone deacetylase inhibitor, entinostat (SNDX-275), for the adjuvant treatment of patients with resected stage I non-small cell lung cancer (NCSLC).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAzacitidine and Entinostat

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 5, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?9 U.S. locations

Locations may change over time.

Who runs it?National Cancer Institute (NCI)

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: National Cancer Institute (NCI)
Interventions being studied: Drug: Azacitidine; Drug: Entinostat; Other: Laboratory Biomarker Analysis

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Early-stage or resectable→

Treatment approach

Surgery→

Study topics

After surgery (adjuvant)→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Patients must be status post complete (R0) surgical resection of pathologically-proven NSCLC (stage IA-IB according to AJCC version 7)
Patients must be at least 4 weeks out from completion of surgery
Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
Absolute neutrophil count \>= 1,000/mcL
Platelets \>= 100,000/mcL
Total bilirubin =\< 1.5 X institutional upper limit of normal
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal
Creatinine =\< 1.5 X institutional upper limit of normal
The effects of entinostat and 5-azacitidine on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Ability to understand and the willingness to sign a written informed consent document

Reasons someone may not be able to joinExclusion criteria

Patients must be within 8 weeks of completing surgery
Patients who have received prior chemotherapy or radiation for treatment of their current diagnosis of lung cancer
Patients with sub-lobar resections (ie: wedge resection or segmentectomy)
Patients without mediastinal lymph node specimens from mediastinoscopy or surgery (at least level R4 or 7 for right sided tumors OR at least level 5, 6 or 7 for left sided tumors)
Patients may not be receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to entinostat, 5-azacitidine or other agents used in the study
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study because entinostat and 5-azacitidine are agents with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with entinostat or 5-azacitidine, breastfeeding should be discontinued if the mother is treated on this protocol; these potential risks may also apply to other agents used in this study
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with entinostat or 5-azacitidine; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

USC / Norris Comprehensive Cancer CenterLos Angeles, California
Moffitt Cancer CenterTampa, Florida
Anne Arundel Medical CenterAnnapolis, Maryland
Greater Baltimore Medical CenterBaltimore, Maryland
Johns Hopkins Bayview Medical CenterBaltimore, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins HospitalBaltimore, Maryland
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania
Vanderbilt-Ingram Cancer CenterNashville, Tennessee
University of Texas Southwestern Medical CenterDallas, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 5, 2019. Always confirm current availability with the study team.

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