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Non Small Cell Lung CancerPhase 2NCT07249372

DRP-104 in Patients With NFE2L2/KEAP1-altered Non-Small Cell Lung Cancer

A Phase 2 study testing DRP-104 in people with Non Small Cell Lung Cancer, run by NYU Langone Health at 2 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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
DRP-104
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
2 sitesUnited States
Study dates
14 Jan 2026to 31 Oct 2028
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

  • Signed informed consent form
  • 18 years of age or older
  • Diagnosis of advanced or recurrent, histologically or cytologically confirmed metastatic or unresectable non-small cell lung cancer harboring NFE2L2 or KEAP1 alterations
  • Patients must have Response Evaluation Criteria in Solid Tumors (RECIST) measurable lesions
  • At the time of enrollment, patients must have experienced progression of disease following treatment with standard of care chemotherapy and immune checkpoint inhibitors either sequentially or concurrently
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
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  • Patient should consent to allow the acquisition of existing Formalin-Fixed Paraffin-Embedded (FFPE) tumor tissue, as unstained slides, if available or to undergo a fresh tissue biopsy to obtain fresh tumor tissue for performance of correlative studies if deemed feasible. Tumor biopsies should only be performed if deemed safe and feasible by the investigator.
  • Adequate baseline organ function:
  • Absolute neutrophil count (ANC) ≥ 1.5x109/L (1500/uL);
  • Without growth factor support for 7 days prior to screening labs for short acting growth factors and 14 days prior to screening labs for long-acting growth factors to meet eligibility
  • b) Hemoglobin ≥ 9 g/dL
  • Patients that require transfusion or growth factors need to demonstrate stable hemoglobin of ≥ 9 g/dL over at least a 7-day period after the last transfusion/growth factor injection prior to screening labs to meet eligibility)
  • c) Platelets >75x109/L
  • No transfusion 7 days prior to screening labs to meet eligibility
  • d) Hepatic
  • Total bilirubin ≤1.5 x upper limit of normal (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
  • Adequate renal function as defined as 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
  • Women of childbearing potential (WOCBP) and men who are sexually active with WOCBP must agree to use one highly effective method of contraception, including hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy or tubal ligation; and one effective method of contraception, including male condom, female condom, cervical cap, diaphragm or contraceptive sponge or abstain from heterosexual intercourse for the duration of study participation and for 5 half-lives of study drug plus 30 days (duration of ovulatory cycle) for a total of 5 weeks after completion of DRP-104. In addition, women must refrain from donating eggs during this time.
  • Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 5 half-lives of study drug plus 90 days (duration of sperm turnover) for a total of 14 weeks post completion of DRP-104. In addition, males must refrain from sperm donation during this time.
  • Women must not be pregnant or breastfeeding or have intention of becoming pregnant during the study treatment or within for 5 half-lives of study drug plus 30 days (duration of ovulatory cycle) for a total of 5 weeks after completion of DRP-104.

Who cannot join

  • Target disease related criteria
  • Patients with progressive or symptomatic brain metastases will be excluded. Patients with brain metastases may be included in this trial as long as the brain metastases have completed definitive treatment at least 14 days prior treatment start and are radiologically stable (i.e., without evidence of progression on screening imaging assessment, [Note: repeat imaging should be performed during study screening]). Patients must be clinically stable and have discontinued anti-seizure medications and steroids, except for physiologic steroid dosing (≤10 mg/day of prednisone equivalents), for at least 14 days prior to Cycle 1 Day 1.
  • Any evidence of leptomeningeal disease
  • Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for at least 8 weeks prior to Cycle 1 Day 1 and must have discontinued steroids, except for physiologic steroid dosing (≤10 mg/day of prednisone equivalents)
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently); Patients with indwelling catheters (e.g., PleurX) are allowed regardless of drainage frequency
  • Prior therapy
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  • Patients who have not recovered to grade 1 or baseline from adverse events (CTCAE v 5.0) related to prior therapy excluding alopecia, peripheral neuropathy and ototoxicity, which are excluded if ≥ grade 3. Lymphopenia ≤ grade 3 is allowed if not related to prior anticancer therapy. If related to prior anticancer therapy, lymphopenia must resolve to ≤ grade 1 or baseline.
  • Prior glutaminase inhibitor use
  • 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. Note: Patients must have recovered from all AEs due to previous therapies to CTCAE v 5.0 grade 1 or baseline, excluding, alopecia, peripheral neuropathy and ototoxicity, which must be at least grade 2 or baseline.
  • 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). Patients must have recovered from all radiation-related toxicities to CTCAE v 5.0 grade 1 or baseline, not require corticosteroids, and not have had radiation pneumonitis.
  • 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
  • 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)
  • Patients receiving potent inducers of CYP 3A4/5 (including St. John's Wort) that cannot be discontinued at least 14 days prior to Cycle 1 Day 1
  • Medical history and concurrent disease
  • Malignant disease, other than that being treated in this study. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. Other exceptions include malignancies that were treated curatively and have not recurred within 3 years prior to Cycle 1 Day 1and any malignancy considered indolent and has never required therapy.
  • Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority
  • Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required during screening.
  • Impairment of gastrointestinal (GI) function or GI disease that may limit the ability to assess GI associated adverse events (e.g., ulcerative disease, uncontrolled nausea and diarrhea, vomiting, malabsorption syndrome, obstruction, or stomach and/or small bowel resection)
  • Uncontrolled concurrent illness including, but not limited to: ongoing or active infection; transfusion dependent thrombocytopenia or anemia that prevent meeting hematological inclusion criteria; psychiatric illness/social situations that would limit compliance with study requirements
  • Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following: Symptomatic congestive heart failure; Unstable angina pectoris or cardiac arrhythmia; Baseline corrected QTcF (Fridericia) ≥ 470 milliseconds; Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome
  • A known or underlying medical condition that, in the opinion of the investigator or Sponsor, could make the administration of study drug/treatment hazardous to the patient, or could adversely affect the ability of the patient to comply with or tolerate the study

Trial locations and contacts

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

Salman Punekar, MD contact

212 731 6228

salman.punekar@nyulangone.org

United States2 sites, 2 recruiting

  • NYU Langone Health

    New York, New York, 10016

    Recruiting

  • Columbia University

    New York, New York, 10032

    Brian S Henick, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2 Study of DRP-104, a Glutamine Antagonist, in Patients With NFE2L2/KEAP1-altered Non-Small Cell Lung Cancer

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.

Being tested
DRP-104
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • DRP-104Drug

    DRP-104 will be administered subcutaneously (subQ) at a dose of 145mg twice a week (BIW) on a continuous schedule. Once the first dose is administered, the second weekly dose is to be administered 3 days after the first dose with a four-day rest period before the next week of therapy (example, Monday/Thursday or Tuesday/Friday).

Study groups in NCT07249372
Study groupRoleWhat they receive
NFE2L2/KEAP1-Altered NSCLCExperimentalParticipants with NFE2L2/KEAP1-altered non-small cell lung cancer previously treated with chemotherapy and immunotherapy will receive subcutaneous DRP-104 (BIW) on a 21-day cycle with no rest period between cycles but with at least 3 days between injections.
Receives: Drug: DRP-104

What is being measured

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

  1. Overall Response Rate (ORR)

    ORR defined as the percentage of participants with a documented response [complete response (CR) or partial response (PR)] to the intervention.

    Measured: Up to Year 2

Secondary outcomes (5)

  1. Progression-Free Survival (PFS)

    Measured as the time from first treatment with the intervention to date of first documented progression of disease - assessed among treated patients only.

    Measured: Up to Year 2

  2. Percentage of Patients with a Best Overall Response (BOR) of CR

    Measured: Up to Year 2

  3. Percentage of Patients with a Best Overall Response (BOR) of PR

    Measured: Up to Year 2

  4. Percentage of Patients with a Best Overall Response (BOR) of SD

    Measured: Up to Year 2

  5. Overall Survival (OS)

    OS measured as the time from first treatment with the intervention until death due to any cause.

    Measured: Up to Year 4

Timeline

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

  1. First posted25 Nov 2025
  2. Study start14 Jan 2026
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion31 Oct 2028 (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
Masking
None (open label)
Enrolment
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07249372
Sponsor's protocol ID
s24-00948
Status last verified
May 2026
First submitted
18 Nov 2025
Last updated
26 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: salman.punekar@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DRP-104 in people with Non Small Cell Lung Cancer, run by NYU Langone Health at 2 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 25 inclusion and 21 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 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 Salman Punekar, MD (212 731 6228, salman.punekar@nyulangone.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: Up to Year 2). 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 NCT07249372.

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 26 May 2026.

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