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A Study of ZEN003694 in People With Squamous Cell Lung Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Study of ZEN003694 in People With Squamous Cell Lung Cancer

Phase 2 Trial of ZEN003694 in Squamous Cell Lung Cancer Patients Harboring NSD3 Amplification

NCT05607108•Memorial Sloan Kettering Cancer Center

Summary

The purpose of this study is to find out whether ZEN003694 is an effective treatment for people with advanced squamous cell lung cancer with a mutation in the NSD3 gene. ZEN003694 is a type of drug called a BET inhibitor. Researchers think ZEN003694 may help here because the drug works by blocking a group of proteins called bromodomain and extra-terminal (BET) proteins, which may counteract the effect of NSD3 on tumor growth. Blocking these proteins may slow or stop the growth of the cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically-confirmed squamous cell lung cancer
•Recurrent or metastatic disease
•Patients with previously treated asymptomatic brain metastases requiring no more than 10mg prednisone (or equivalent) are allowed. Patients with asymptomatic brain metastases ≤ 1cm not requiring more than 10mg prednisone (or equivalent) are allowed.
•Received prior first-line therapy: platinum-based chemotherapy and immunotherapy, given either concurrently or sequentially
•Eastern Cooperative Oncology Group (ECOG) PS 0-2
•Evidence of NSD3 gain or amplification by NGS, including but not limited to evidence of 8p11 gain or amplification as determined by MSK IMPACT or MSK ACCESS, or a commercially available molecular assay that is FDA authorized. Note: ctDNA testing, including but not limited to MSK ACCESS and Guardant and Foundation
•Adequate laboratory parameters at Screening including:
•* Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
•* Platelet count ≥ 100,000/mm\^3
•* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.0 ULN (≤ 5 x ULN if liver metastases are present)
+11 more criteria

Exclusion Criteria

•Have previously received an investigational BET inhibitor
•Have received prior systemic anti-cancer therapy or investigational therapy within 2 weeks or five half-lives, whichever is shorter, prior to the first dose of study drug
•Radiation therapy within 2 weeks of first dose of study drug
•Currently receiving medications known to be strong inducers or inhibitors of CYP3A4 and substrates of CYP1A2 with a narrow therapeutic window. Strong inducers and inhibitors of CYP3A4 and CYP1A2 substrates with narrow therapeutic ranges must be discontinued at least 7 days prior to the first administration of study drug.
•Left ventricular ejection fraction less than the lower of 50% or the lower limit of institution's normal range
•QTcF interval \> 470 msec
•Known impaired cardiac function or clinically significant cardiac disease such as uncontrolled supraventricular arrhythmia, ventricular arrhythmia requiring therapy, or uncontrolled congestive heart failure (New York Heart Association functional class III or IV)
•Myocardial infarction or unstable angina within 6 months prior to the first administration of study drug
•Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active CNS disease, active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, or any other condition that could compromise safety or the patient's participation in the study
•Other known active cancer requiring therapy at time of study entry
+5 more criteria

Locations (7)

Memorial Sloan Kettering at Basking Ridge Limited Protocol Activities

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )

Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, United States

Key Dates

Start Date

November 1, 2022

Primary Completion Date

November 1, 2027

Completion Date

November 1, 2027

Last Updated

March 11, 2026

Enrollment

ESTIMATED participants

Conditions

Squamous Cell Lung Cancer

Interventions

ZEN003694

DRUG

Contacts

Paul Paik, MD

CONTACT

646-608-3759 paikp@mskcc.org

Mark Kris, MD

CONTACT

646-608-3914

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of ZEN003694 in People With Squamous Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects With Advanced Solid Tumors

APOLLO 11, Consortium of Italian Centers Involved in Treatment of Patients With Lung Cancer Treated With Innovative Therapies: Real World Data and Translational Reaserch

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