OncoMatch/Clinical Trials/NCT05607108
A Study of ZEN003694 in People With Squamous Cell Lung Cancer
Is NCT05607108 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies ZEN003694 for squamous cell lung cancer.
Treatment: ZEN003694 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: NSD3 gain or amplification
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: platinum-based chemotherapy — first-line
Received prior first-line therapy: platinum-based chemotherapy and immunotherapy, given either concurrently or sequentially
Must have received: immunotherapy — first-line
Received prior first-line therapy: platinum-based chemotherapy and immunotherapy, given either concurrently or sequentially
Cannot have received: BET inhibitor
Have previously received an investigational BET inhibitor
Cannot have received: systemic anti-cancer therapy or investigational therapy
Exception: within 2 weeks or five half-lives, whichever is shorter, prior to the first dose of study drug
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
Cannot have received: radiation therapy
Exception: within 2 weeks of first dose of study drug
Radiation therapy within 2 weeks of first dose of study drug
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L; Platelet count ≥ 100,000/mm^3; Prothrombin time (PT), INR and partial thromboplastin time (PTT) < 1.5 x ULN
Kidney function
Calculated or measured eGFR ≥ 40 ml/min or serum creatinine ≤ 1.5 x ULN
Liver function
AST or ALT ≤ 2.0 ULN (≤ 5 x ULN if liver metastases are present); Total bilirubin ≤ 1.25 x ULN
Cardiac function
Left ventricular ejection fraction ≥ 50% or institution's lower limit of normal; QTcF interval ≤ 470 msec
Adequate laboratory parameters at Screening including: Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L; Platelet count ≥ 100,000/mm^3; AST or 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), INR and partial thromboplastin time (PTT) < 1.5 x ULN; Left ventricular ejection fraction less than the lower of 50% or the lower limit of institution's normal range; QTcF interval > 470 msec
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering at Basking Ridge Limited Protocol Activities · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (All Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (All Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities ) · Commack, New York
- Memorial Sloan Kettering Westchester (All Protocol Activities) · Harrison, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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