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Squamous Cell Lung CancerPhase 2NCT05607108

A Study of ZEN003694 in People With Squamous Cell Lung Cancer

A Phase 2 study testing ZEN003694 in people with Squamous Cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Lung Cancer
What is being tested?
ZEN003694
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
7 sitesUnited States
Study dates
1 Nov 2022to Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)
  • Total bilirubin ≤ 1.25 x ULN
  • Calculated or measured eGFR ≥ 40 ml/min or serum creatinine ≤ 1.5 x ULN
  • Prothrombin time (PT), international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.5 x ULN
  • Ability to swallow capsules
  • Use of corticosteroids is allowed up to a daily dose of 10 mg prednisone or equivalent provided that the dose has been stable for at least 2 weeks prior to the start of ZEN003694 dosing and will remain stable during ZEN003694 treatment.
  • Females or males age ≥ 18 years (at time of signing informed consent)
  • Female subjects may be enrolled if they are not of childbearing potential, permanently sterile or who are post-menopausal defined as no menses for at least 1 year without an alternative medical cause and FSH levels in the post-menopausal range. Female subjects of childbearing potential may be enrolled if they consistently and correctly use a highly effective form of contraception. Highly effective forms of contraception include: combined (estrogen and progestogen hormonal contraceptives (oral, intravaginal, transdermal) associated with inhibition of ovulation; progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; sexual abstinence. Female subjects should not donate eggs from the time point of study drug administration until at least 7 months thereafter.
  • Males with partners of childbearing potential may be enrolled if they use a condom when having sex with a pregnant woman or with a non-pregnant female of childbearing potential from 21 days before the first dose of study drug through 4 months after the last dose of study drug, and males should not donate sperm from the time point of study drug administration until at least 4 months thereafter.
  • Contraception should be considered for a non-pregnant female partner of childbearing potential
  • Females of childbearing potential must have a negative serum or urine pregnancy test before the first dose of study drugs and must agree to pregnancy tests during the study.
  • Females may not be breast-feeding at the first dose of study drugs, during study participation or through 7 months after the last dose of study drugs

Who cannot join

  • 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
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  • 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
  • Historically positive (screening tests not required) for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) or with active infections. HBV positivity defined by positive hepatitis B surface antigen (HBsAg). HCV positivity defined as positive HCV viral load.
  • Major surgery other than diagnostic surgery, dental surgery or stenting within 4 weeks prior to the first administration of study drug
  • History of congenital or other deficiency in platelet function, or any known inherent or acquired coagulopathy, including current anticoagulation therapy (except for low-dose warfarin for port patency)
  • Current or anticipated use within 7 days prior to the first administration of study drug, or during the study, of strong P-gp inhibitors.
  • Use of oral Factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and Factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed. Note: except for subjects on anticoagulant therapy who must have PT-INR within therapeutic range as deemed appropriate by the Investigator.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Paul Paik, MD contact

646-608-3759

paikp@mskcc.org

Kathryn Arbour, MD contact

646-608-3792

7 sites in 1 country

United States7 sites, 7 recruiting

  • Memorial Sloan Kettering at Basking Ridge Limited Protocol Activities

    Basking Ridge, New Jersey, 07920

    Paul Paik, MD, 646-608-3759

    Recruiting

  • Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )

    Commack, New York, 11725

    Paul Paik, MD, 646-608-3759

    Recruiting

  • Memorial Sloan Kettering Westchester (All Protocol Activities)

    East White Plains, New York, 10604

    Paul Paik, MD, 646-608-3759

    Recruiting

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown, New Jersey, 07748

    Paul Paik, MD, 646-608-3759

    Recruiting

  • Memorial Sloan Kettering Bergen (All Protocol Activities)

    Montvale, New Jersey, 07645

    Paul Paik, MD, 646-608-3759

    Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065

    Paul Paik, MD, 646-608-3759

    Recruiting

  • Memorial Sloan Kettering Nassau (All Protocol Activities)

    Uniondale, New York, 11553

    Paul Paik, MD, 646-608-3759

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
ZEN003694
Keywords
Metastatic, Recurrent, ZEN003694, NSD3 Amplification, 22-286
Medical subject headings
Neoplasm Metastasis, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZEN003694Drug

    ZEN003694 60mg po qd on a 5 days on 2 days off schedule in an every 21-day cycle

Study groups in NCT05607108
Study groupRoleWhat they receive
ZEN003694ExperimentalAll patients enrolled on the study will undergo treatment with ZEN003694 60mg po qd on a 5 days on/2 days off schedule in an every 21-day cycle. All assessments, including drug dosing, have a window of +/- 7 days unless otherwise noted.
Receives: Drug: ZEN003694

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall response rate (ORR)

    Response to ZEN003694 will be determined using the sum unidimensional measurements of the target lesions present on the scan. Unidimensional measurement rules will adhere to RECIST 1.1 guidelines.(6) Classification of response will be categorized by RECIST 1.1 (CR, PR, SD, PD).

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2022
  2. Study start1 Nov 2022
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a single-arm phase 2 study of ZEN003694 in patients with advanced NSD3- amplified squamous cell lung cancer.
Masking
None (open label)
Enrolment
13 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05607108
Sponsor's protocol ID
22-286
Status last verified
Sep 2026
First submitted
1 Nov 2022
Last updated
23 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ZEN003694 in people with Squamous Cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Paul Paik, MD (646-608-3759, paikp@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall response rate (ORR) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05607108.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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