Actively Recruiting
Ladarixin With Sotorasib in Advanced NSCLC
Led by NYU Langone Health · Updated on 2025-12-30
40
Participants Needed
6
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase I/II, open-label, study of twice-daily oral ladarixin with sotorasib in participants with advanced KRASG12C mutant non-small cell lung cancer (NSCLC).
CONDITIONS
Official Title
Ladarixin With Sotorasib in Advanced NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent signed and dated before any study procedures
- Age 18 years or older at time of consent
- ECOG performance status of 0 or 1
- Histologically confirmed non-small cell lung cancer (squamous or nonsquamous)
- Metastatic or locally advanced NSCLC not suitable for curative surgery or radiation
- No EGFR mutation, ALK translocation, RET, ROS1, or other actionable molecular alterations treatable with FDA-approved agents
- Documented KRAS G12C mutation in tumor tissue
- Disease progression after anti-PD (L)-1 therapy with or without platinum-based chemotherapy
- At least one measurable tumor lesion per RECIST v1.1 criteria
- Laboratory values at screening meeting specified blood count and organ function thresholds
- Negative pregnancy test for persons of childbearing potential assigned female at birth
- Women of non-childbearing potential must meet criteria for menopause or surgical sterilization
- Persons assigned male at birth with partners of childbearing potential and persons of childbearing potential must use two forms of contraception during and 3 months after study
- Able to swallow and retain oral medication
You will not qualify if you...
- History or presence of hematological malignancies within 1 year except stable CLL
- History of other cancers within 1 year except certain non-invasive or treated cancers
- Known serious allergies to ladarixin, sotorasib, or their excipients
- Severe autoimmune disease or autoimmune disorder requiring chronic immunosuppressive corticosteroids within 6 months
- Brain or spinal metastases unless treated and stable without progression or hemorrhage for 7 days
- Pericarditis or pericardial effusion within 6 months
- History of interstitial lung disease or related pulmonary conditions
- Active infection requiring systemic treatment at study start
- HIV positive status
- Active hepatitis B or C infection unless controlled and monitored
- Severe or uncontrolled medical conditions affecting study participation
- Recent history of acute myocardial infarction, unstable angina, coronary artery bypass, or stroke within 6 months
- Significant cardiac diseases including arrhythmias, low ejection fraction, bradycardia, or heart failure
- Prolonged QT interval (>470 msec) on ECG
- Significant inflammatory eye disease or retinal conditions
- Unresolved grade >1 toxicity except hair loss; grade 2 neuropathy allowed with approval
- Neuromuscular disorders with elevated creatine kinase
- Malignant biliary obstruction without functioning stent
- Pregnant or breastfeeding
- Live vaccine within 30 days before treatment except non-live flu vaccine
- Psychiatric or substance abuse disorders interfering with study cooperation
- Recent or regular illicit drug use or recent substance abuse
- Known hypersensitivity to study drugs or excipients
- Prior treatment with KRAS inhibitors
- History of allogeneic bone marrow or organ transplant
- Recent use of systemic anticancer agents or investigational drugs within specified washout periods
- Radiation therapy within 7 days prior to ladarixin
- Use of drugs or supplements affecting CYP3A4 metabolism within 14 days before treatment
- Recent major surgery or trauma within 28 days
- Use of erythropoietin or certain growth factors within 2 weeks
- Recent blood transfusion within 1 week
- Use of medications with risk of QT prolongation within 2 weeks
- Use of certain antacids or acid reducers within 3 days prior to starting ladarixin
AI-Screening
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Trial Site Locations
Total: 6 locations
1
NYU Langone Health
Garden City, New York, United States, 11530
Actively Recruiting
2
NYU Langone Health
Mineola, New York, United States, 11501
Actively Recruiting
3
NYU Langone Health
New Hyde Park, New York, United States, 11042
Actively Recruiting
4
NYU Langone Health
New York, New York, United States, 10010
Actively Recruiting
5
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
6
NYU Langone Health
New York, New York, United States, 10017
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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