Actively Recruiting
DRP-104 in Patients With NFE2L2/KEAP1-altered Non-Small Cell Lung Cancer
Led by NYU Langone Health · Updated on 2025-11-25
37
Participants Needed
2
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 2 Study of DRP-104, a Glutamine Antagonist, in Patients with NFE2L2/KEAP1-altered Non-Small Cell Lung Cancer following standard of care treatment with chemotherapy and immunotherapy.
CONDITIONS
Official Title
DRP-104 in Patients With NFE2L2/KEAP1-altered Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- 18 years of age or older
- Diagnosis of advanced or recurrent metastatic or unresectable non-small cell lung cancer with NFE2L2 or KEAP1 alterations
- Measurable lesions by RECIST criteria
- Disease progression after prior chemotherapy and immune checkpoint inhibitor treatment
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Consent to provide existing or new tumor tissue samples if safe and feasible
- Adequate organ function including neutrophils, hemoglobin, platelets, liver, kidney, and heart function as defined
- Agreement to use effective contraception during and after the study if of childbearing potential or sexually active with such individuals
- Not pregnant or breastfeeding and no intention to become pregnant during the study and specified period after treatment
You will not qualify if you...
- Progressive or symptomatic brain metastases unless treated and stable for at least 14 days
- Presence of leptomeningeal disease
- Untreated or unstable spinal cord compression
- Uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage
- Unresolved adverse events from prior therapy above grade 1 except specified exceptions
- Prior use of glutaminase inhibitors
- Recent systemic anticancer treatment within specified washout periods
- Recent palliative or definitive radiotherapy with incomplete recovery
- Recent use of myeloid growth factors within specified periods
- Major surgery within 21 days with incomplete recovery
- Use of medications that strongly induce CYP 3A4/5 that cannot be stopped
- Other active malignancies except certain skin cancers or in situ carcinomas with curative treatment
- Known HIV, active Hepatitis B or C infections
- Gastrointestinal conditions affecting assessment of adverse events
- Uncontrolled infections or illnesses
- Significant uncontrolled heart disease or abnormal heart rhythm
- Any medical condition that may increase risk or interfere with study compliance as judged by investigator or Sponsor
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
2
Columbia University
New York, New York, United States, 10032
Actively Recruiting
Research Team
S
Salman Punekar, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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