OncoMatch/Clinical Trials/NCT07249372
DRP-104 in Patients With NFE2L2/KEAP1-altered Non-Small Cell Lung Cancer
Is NCT07249372 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies DRP-104 for non small cell lung cancer.
Treatment: DRP-104 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: KEAP1 alteration
Required: NFE2L2 alteration
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy — standard of care
progression of disease following treatment with standard of care chemotherapy
Must have received: checkpoint inhibitor — standard of care
progression of disease following treatment with...immune checkpoint inhibitors either sequentially or concurrently
Cannot have received: glutaminase inhibitor
Prior glutaminase inhibitor use
Cannot have received: systemic anticancer treatment
Exception: within 21 days or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1; anti-PD-1/PD-L1 antibody allowed if last dose is 14 days prior to Cycle 1 Day 1
Prior systemic anticancer treatment (i.e., chemotherapy, biologic therapy [i.e., small molecular inhibitors], monoclonal antibodies, investigational agents]) within 21 days or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1. If a patient is receiving an anti-PD-1 or anti-PD-L1 antibody on a shorter frequency, i.e., every two weeks, then the patient is eligible if last dose is 14 days prior to Cycle 1 Day 1.
Cannot have received: palliative radiotherapy
Exception: within 14 days prior to Cycle 1 Day 1 or within 42 days prior to Cycle 1 Day 1 from definitive local control radiation (any dose greater than 50 Gy, within 42 days of Cycle 1 Day1)
Prior palliative radiotherapy within 14 days prior to Cycle 1 Day 1 or within 42 days prior to Cycle 1 Day 1 from definitive local control radiation (any dose greater than 50 Gy, within 42 days of Cycle 1 Day1)
Cannot have received: long-acting myeloid growth factor
Exception: within 14 days prior to Cycle 1 Day 1
Prior therapy with long-acting myeloid growth factor or from a short acting myeloid growth factor within 14 days or 7 days prior to Cycle 1 Day 1, respectively
Cannot have received: short-acting myeloid growth factor
Exception: within 7 days prior to Cycle 1 Day 1
Prior therapy with long-acting myeloid growth factor or from a short acting myeloid growth factor within 14 days or 7 days prior to Cycle 1 Day 1, respectively
Cannot have received: major surgery
Exception: within 21 days prior to Cycle 1 Day 1 or who have not recovered from side effects of such procedure (CTCAE v 5.0 grade 1 or baseline)
Any major surgery within 21 days prior to Cycle 1 Day 1 or who have not recovered from side effects of such procedure (CTCAE v 5.0 grade 1 or baseline)
Lab requirements
Blood counts
ANC ≥ 1.5x10^9/L (1500/uL) without growth factor support for 7 days (short acting) or 14 days (long acting) prior to screening labs; Hemoglobin ≥ 9 g/dL (stable for ≥ 7 days after last transfusion/growth factor); Platelets >75x10^9/L, no transfusion 7 days prior to screening labs
Kidney function
Creatinine clearance ≥ 50 ml/min/1.73m2 measured or calculated by the Cockcroft-Gault equation or GFR ≥ 50 mL/min/1.73 m² by MDRD
Liver function
Total bilirubin ≤1.5 x ULN or, in patients with Gilbert syndrome, total bilirubin >1.5 x ULN as long as direct bilirubin is normal; PT/INR and PTT ≤1.5 x ULN, unless treated with anticoagulants; AST(SGOT)/ALT(SGPT) ≤3 x ULN or ≤5 x ULN for patients with liver metastases/tumor infiltration
Cardiac function
Corrected QTc (Fridericia) < 470 ms
Adequate baseline organ function: a) Absolute neutrophil count (ANC) ≥ 1.5x109/L (1500/uL); b) Hemoglobin ≥ 9 g/dL; c) Platelets >75x109/L; d) Hepatic: Total bilirubin ≤1.5 x ULN or, in patients with Gilbert syndrome, total bilirubin >1.5 x ULN as long as direct bilirubin is normal; PT/INR and PTT ≤1.5 x ULN, unless treated with anticoagulants; AST(SGOT)/ALT(SGPT) ≤3 x ULN or ≤5 x ULN for patients with liver metastases/tumor infiltration; e) Renal: Creatinine clearance ≥ 50 ml/min/1.73m2 measured or calculated by the Cockcroft-Gault equation or GFR ≥ 50 mL/min/1.73 m² by MDRD; f) Cardiac: Corrected QTc (Fridericia) < 470 ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- NYU Langone Health · New York, New York
- Columbia University · New York, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07249372 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior glutaminase inhibitor, systemic anticancer treatment, palliative radiotherapy disqualifies patients from enrollment.
Does this trial require KEAP1?
Yes, KEAP1 alteration is a required biomarker for enrollment.
Does this trial require NFE2L2?
Yes, NFE2L2 alteration is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages