~4 spots leftby Nov 2025

ZEN003694 for Squamous Cell Lung Cancer

Recruiting at 6 trial locations
Paul K. Paik, MD - MSK Thoracic Medical ...
Overseen byPaul Paik
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Memorial Sloan Kettering Cancer Center
Must not be taking: CYP3A4 inducers, CYP1A2 substrates, P-gp inhibitors, Factor Xa/IIa inhibitors
Disqualifiers: Cardiac disease, Active infections, Others
No Placebo Group
Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial requires stopping medications that are strong inducers or inhibitors of CYP3A4 and substrates of CYP1A2 with a narrow therapeutic window at least 7 days before starting the study drug. If you're on these medications, you may need to stop them. The protocol does not specify other medications, so consult with the trial team for guidance.

What data supports the idea that ZEN003694 for Squamous Cell Lung Cancer (also known as: ZEN003694, ZEN-3694) is an effective treatment?

The available research does not provide specific data on the effectiveness of ZEN003694 for Squamous Cell Lung Cancer. Instead, it discusses the general progress in treatments for this type of cancer, including the development of new therapies and clinical trials. Other treatments, like immunotherapy and combinations of chemotherapy drugs, have shown promise in improving outcomes for patients with this condition.12345

What safety data exists for ZEN003694 in treating squamous cell lung cancer?

The provided research does not specifically mention safety data for ZEN003694 or ZEN-3694 in the treatment of squamous cell lung cancer. The articles focus on the safety and adverse events of other targeted therapies and immunotherapies for non-small cell lung cancer, including PD-1/PD-L1 inhibitors, but do not provide information on ZEN003694. Further specific studies or clinical trial data would be needed to determine the safety profile of ZEN003694.26789

Is the drug ZEN003694 a promising treatment for squamous cell lung cancer?

Yes, ZEN003694 is a promising drug for squamous cell lung cancer because recent research has identified new targets in the cancer's biology, leading to the development of targeted treatments like ZEN003694. These advancements offer new hope for patients by potentially improving survival rates and providing more effective treatment options.26101112

Research Team

Paul K. Paik, MD - MSK Thoracic Medical ...

Paul Paik

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

Adults with advanced squamous cell lung cancer and NSD3 gene mutation can join this trial. They must have had prior chemotherapy and immunotherapy, be able to swallow capsules, and not be pregnant or breastfeeding. Stable brain metastases are okay. Participants need proper organ function, no recent heart attacks or surgeries, and cannot have HIV/HBV/HCV or other significant health issues.

Inclusion Criteria

Contraception should be considered for a non-pregnant female partner of childbearing potential
I am not breastfeeding and will not be during the study.
I am not pregnant and agree to regular pregnancy tests during the study.
See 10 more

Exclusion Criteria

My heart's pumping ability is below normal.
I am taking medication that strongly affects liver enzymes.
Historically positive for HIV, HBV, or HCV or with active infections
See 12 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • ZEN003694 (BET inhibitor)
Trial OverviewThe study is testing ZEN003694's effectiveness for squamous cell lung cancer with an NSD3 mutation. It's a BET inhibitor that may slow down tumor growth by blocking proteins involved in cancer progression.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: ZEN003694Experimental Treatment1 Intervention
All 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+
Lisa M. DeAngelis profile image

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers profile image

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University

Zenith Epigenetics

Industry Sponsor

Trials
10
Recruited
590+

Findings from Research

In a phase 3 clinical trial involving 355 patients with advanced squamous non-small-cell lung cancer (sq-NSCLC), the combination of tislelizumab and chemotherapy significantly improved progression-free survival (PFS) compared to chemotherapy alone, with PFS of 7.6 months for the combination versus 5.5 months for chemotherapy alone.
The addition of tislelizumab also resulted in higher objective response rates (ORR) and longer duration of response, while maintaining a manageable safety profile, with no deaths directly attributed to tislelizumab.
Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as First-line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer: A Phase 3 Randomized Clinical Trial.Wang, J., Lu, S., Yu, X., et al.[2022]
Recent research has made significant strides in understanding squamous cell lung cancer (SCC), identifying new genomic and signaling pathways that could lead to targeted therapies.
Emerging prognostic gene signatures and predictive biomarkers are paving the way for innovative clinical trials, such as the Lung-MAP master protocol, aimed at improving treatment options for patients with advanced SCC.
Squamous cell lung cancer: from tumor genomics to cancer therapeutics.Gandara, DR., Hammerman, PS., Sos, ML., et al.[2023]
In a phase II trial involving 47 patients with extensive-stage small cell lung cancer, docetaxel demonstrated efficacy with a 23% partial response rate and a median overall survival of 9 months.
The treatment was generally well tolerated, although 58% of patients experienced grade 4 neutropenia, indicating that while docetaxel is effective, it can cause significant blood-related side effects that need to be managed.
Evaluation of docetaxel in previously untreated extensive-stage small cell lung cancer: a Southwest Oncology Group phase II trial.Hesketh, PJ., Crowley, JJ., Burris, HA., et al.[2018]

References

Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as First-line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer: A Phase 3 Randomized Clinical Trial. [2022]
Squamous cell lung cancer: from tumor genomics to cancer therapeutics. [2023]
Evaluation of docetaxel in previously untreated extensive-stage small cell lung cancer: a Southwest Oncology Group phase II trial. [2018]
Unmet needs in squamous cell carcinoma of the lung: potential role for immunotherapy. [2021]
Phase III trial of docetaxel plus gemcitabine versus docetaxel in second-line treatment for non-small-cell lung cancer: results of a Japan Clinical Oncology Group trial (JCOG0104). [2022]
Incremental Innovation and Progress in Advanced Squamous Cell Lung Cancer: Current Status and Future Impact of Treatment. [2018]
Targeted Toxicities: Protocols for Monitoring the Adverse Events of Targeted Therapies Used in the Treatment of Non-Small Cell Lung Cancer. [2023]
Pneumonitis in Non-Small Cell Lung Cancer Patients Receiving Immune Checkpoint Immunotherapy: Incidence and Risk Factors. [2019]
Safety and tolerability of PD-1/PD-L1 inhibitors in the treatment of non-small cell lung cancer: a meta-analysis of randomized controlled trials. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Immune Microenvironment Differences Between Squamous and Non-squamous Non-small-cell Lung Cancer and Their Influence on the Prognosis. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
New developments in the treatment of squamous cell lung cancer. [2014]
Squamous-cell carcinomas of the lung: emerging biology, controversies, and the promise of targeted therapy. [2022]