Advanced Non-small Cell Lung Cancer With KRAS G12C MutationPhase 1NCT05815173
Ladarixin With Sotorasib in Advanced NSCLC
A Phase 1 study testing Sotorasib and Ladarixin in people with Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation, run by NYU Langone Health at 6 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation
- What is being tested?
- Sotorasib and Ladarixin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Aug 2023to Aug 2027
- Phase
- Phase 1
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent, according to local guidelines, signed and dated by the participant prior to the performance of any study-specific procedures, sampling, or analyses.
- Participant must be ≥18 years of age at the time of signature of the informed consent form (ICF).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Histologically confirmed diagnosis of NSCLC (squamous or nonsquamous).
- Patients with metastatic or locally advanced NSCLC who are not candidates for curative surgery or curative radiation.
- Do not have an epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) translocation, rearranged during transfection (RET), ROS1 or other actionable molecular alterations that can be treated with FDA approved targeted agents.
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- Patients must have documentation of presence of KRASG12C mutation in tumor tissue.
- Patients must have demonstrated progression of disease following treatment with anti-PD (L)-1 with or without platinum-based chemotherapy.
- Participants must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Tumor lesions that have been irradiated ≥4 weeks before the start of treatment, and have subsequently had documented progression, may be chosen as target lesions in the absence of measurable lesions that have not been irradiated.
- Participants whose laboratory data at Screening meet the following criteria:
- Absolute neutrophil count ≥1.5 × 109/L
- Platelets ≥100 × 109/L
- Hemoglobin ≥8 g/dL without transfusion within 7 days
- Albumin ≥3 g/dL
- Lymphocyte count ≥0.5 × 109/L
- Serum bilirubin ≤1.5 × upper limit of normal (ULN), or ≤ 3.0 × ULN for subjects with Gilbert's Syndrome
- AST and ALT ≤ 2x upper limit of normal (ULN)
- International normalization ratio (INR) <1.5 if the patient is not on anticoagulants, or INR <3 after dose titration has been completed if the patient is on anticoagulants.
- Renal clearance as estimated glomerular filtration rate (eGFR) by Modification of Diet in Renal Disease (MDRD) Study equation ≥50 mL/min/1.73m2.
- Persons of childbearing potential (POCBP, defined as a sexually mature person assigned female at birth) must have a negative serum pregnancy test prior to study entry. Women of non-childbearing potential will have had at least 12 continuous months of natural (spontaneous) amenorrhea, and an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms), or have had surgical bilateral oophorectomy, hysterectomy, or bilateral tubal ligation >6 weeks prior to Screening.
- Persons assigned male at birth or persons assigned female at birth participants: Persons assigned male at birth participants with partners of childbearing potential and participants of childbearing potential are required to use 2 forms of acceptable contraception, including 1 barrier method, during their participation in the study and for 3 months following last dose. Persons assigned male at birth participants must also refrain from donating sperm during their participation in the study and for 12 months after the last dose of study medication.
- Participants must be able to swallow and retain orally administered medication.
Who cannot join
- History (≤1 years) or presence of hematological malignancies except stable CLL.
- History (≤1 years) of other cancer that is histologically distinct from the cancers under study, except for cervical carcinoma in situ, ductal carcinoma in situ, prostatic intraepithelial neoplasia, superficial non-invasive bladder tumors, or curatively treated stage I non-melanoma skin cancer.
- Known serious allergy to ladarixin, sotorasib, or excipients (e.g., microcrystalline cellulose).
- History (≤6 months before the start of treatment with the study drugs) of severe autoimmune disease (including ≥ Grade 3 or recurrent Grade 2 immune-related AEs of prior immuno-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone >10 mg/day or equivalent).
- Brain or spinal metastases, except if treated by surgery or surgery plus radiotherapy or radiotherapy alone, with no clinical evidence of progression or hemorrhage for ≤7 days before the start of treatment with the study drugs, and has not received any systemic corticosteroids for ≥7 days before the start of treatment with the study drugs.
- History (≤6 months before the start of treatment with the study drugs) of pericarditis (any grade) or pericardial effusion (Grade ≥2).
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- History of interstitial lung disease, radiation pneumonitis which required steroid treatment, idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, or organizing pneumonia.
- Active infection requiring systemic treatment at the start of treatment in this trial. A washout period of 7 days after the last dose of antibiotics prior to first dose of study drug is required.
- History of seropositive status for human immunodeficiency virus (HIV) at any time before the start of treatment as determined by presence of anti-HIV-1 or anti-HIV-2 antibodies.
- -- Note: Testing for seropositive status during Screening will be at the discretion of the investigator in participants without previously reported results.
- Has active hepatitis B, or hepatitis C infection.
- Note: Participants with hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA polymerase chain reaction (PCR) that is below the limit of detection) are permitted. Participants with controlled infections must undergo periodic monitoring of hepatitis B virus DNA.
- Note: Participants who are hepatitis C virus antibody positive (HCV Ab+), who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) may be enrolled into the study. Participants with controlled infections must undergo periodic monitoring of HCV RNA per treating physician.
- History (≤6 months before the start of treatment) of any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the investigator and sponsor, could affect the patient's participation in the study such as:
- Nonmalignant illnesses that are uncontrolled or whose control may be jeopardized by this study treatment.
- Nonmalignant decompensated liver disease.
- Significant gastrointestinal abnormalities or a chronic condition, including inability to swallow the formulated product, delayed gastric emptying, chronic active Crohn's disease that requires steroid therapy at any dose, refractory nausea and vomiting, and/or prior surgical procedures affecting absorption or requirement for intravenous alimentation.
- History (≤6 months before the start of treatment with the study drugs) of any of the following: acute myocardial infarction, unstable angina pectoris, coronary artery bypass graft, or cerebrovascular accident.
- Participants who have impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- Significant ventricular or supraventricular arrhythmias (patients with sinus arrhythmia or chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible).
- Left ventricular ejection fraction (LVEF) <50% assessed by echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 6 months before the start of treatment with the study drugs and at screening.
- Resting bradycardia (<50 beats per minute) determined as the mean of 3 heart rate values from the screening triplicate 12-lead electrocardiograms (ECGs) obtained.
- Other clinically significant heart disease such as congestive heart failure New York Heart Association Class II-IV.
- Participants with QT interval >470 msec at screening using Fridericia's formula (QTcF), determined as the mean of 3 QTcF values from the screening triplicate ECG.
- Known history (≤6 months before the start of treatment with the study drugs) of significant inflammatory eye disease, central serous retinopathy, uveitis, or evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndrome).
- Participants experiencing unresolved Grade >1 toxicity before the start of treatment with the study drug except for hair loss (alopecia), Grade 2 neuropathy is permitted if the investigator permits and written approval is granted by the medical monitor.
- Participants who have neuromuscular disorders that are associated with elevated creatine kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis spinal muscular atrophy).
- History (≤6 months before the start of treatment with the study drugs) of malignant biliary obstruction, except for patients with a functioning biliary stent.
- Persons who are pregnant or breast-feeding.
- Has received or will receive a live vaccine within 30 days prior to the first administration of study medication. Seasonal flu vaccines that do not contain live vaccine are permitted.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).
- Known or suspected hypersensitivity to the active pharmaceutical ingredient, non-steroidal anti-inflammatory drugs or any excipient of the investigational medicinal products (e.g. lactose and croscarmellose) as well as patients with congenital lactase deficiency, galactosaemia or glucose-galactose intolerance.
- History of treatment with KRAS inhibitors.
- History of an allogeneic bone marrow or solid organ transplant.
- Use of systemic anticancer agent (except for antiandrogen therapy for prostate cancer, therapy for bone metastases or cancer-related hypercalcemia) or investigational drug is prohibited ≤28 days for biologics and intravenous chemotherapy, or ≤14 days or 2 half-lives for small molecules, whichever is longer, prior to the first dose of ladarixin.
- History of radiation therapy ≤7 days prior to the first dose of ladarixin.
- Use of drugs known to be moderate or strong CYP3A4 inhibitors or inducers or sensitive CYP3A4 substrates with a narrow therapeutic index is prohibited ≤14 days before the start of treatment with the study drug until the end-of-treatment visit. Some of these medications may be allowed at the investigator's discretion after written approval by the medical monitor.
- Treatment with drugs metabolized by CYP2C9 with a narrow therapeutic index [i.e., phenytoin, warfarin, and high dose of amitriptyline (>50 mg/day)].
- Use of herbal drugs and supplements known to be moderate or strong CYP3A4 inhibitors or inducers or sensitive CYP3A4 substrates with a narrow therapeutic index is prohibited ≤14 days before the start of treatment with the study drug until the end- of-treatment visit. These herbal medications include but are not limited to: St. John's wort, cannabis (including "medical marijuana"), kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng.
- History (≤28 days before the start of treatment with the study drugs) of major surgery or trauma or likelihood to require surgery at any time until the permanent discontinuation of treatment (the significance will be determined by the investigator after consultation with the medical monitor).
- Participants who start erythropoietin or G-CSF, pegfilgrastim, or filgrastim ≤2 weeks before start of treatment with the study drug.
- History (≤1 weeks before the first dose of ladarixin) of transfusion of whole blood, red blood cells or platelet packets.
- History (≤2 weeks before the start of treatment with the study drugs) of medications with known risk of Torsades de Pointes (cardiac arrhythmia due to drug-induced QTc prolongation).
- Use of H2-receptor antagonists, proton pump inhibitors, and/or intraluminal antacids within 3 days or 5 half-lives (whichever is longer) prior to starting ladarixin.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
NYU Langone Health
Garden City, New York, 11530
- Recruiting
NYU Langone Health
Mineola, New York, 11501
- Recruiting
NYU Langone Health
New Hyde Park, New York, 11042
- Recruiting
NYU Langone Health
New York, New York, 10010
- Recruiting
NYU Langone Health
New York, New York, 10016
- Recruiting
NYU Langone Health
New York, New York, 10017
About this study
Official title: Phase I/II Study of Ladarixin and Sotorasib in Advanced KRAS G12C Mutant Non-Small Cell Lung Cancer (NSCLC)
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).
Read the detailed description
This study will enroll patients with KRASG12C mutant NSCLC not previously treated with KRASG12C inhibitors. Patients in this study will receive ladarixin and sotorasib. The primary objective of the Phase I portion is to define a recommended phase II dose (RP2D) of ladarixin when combined with sotorasib. The primary objective of the Phase II portion is to evaluate progression free survival (PFS).
- Being tested
- Sotorasib, Ladarixin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotorasibDrug
Sotorasib administered at the approved dose of 960mg PO once daily over 21-day treatment cycles.
LadarixinDrug
Ladarixin dose will be escalated as follows in Phase I: 3 patients will receive a starting dose of 200mg. If 2 or more patients experience a DLT at the lowest dose, the study will stop. If 0 out of 3 patients experience a DLT within 28 days, the next 3 patients will receive 300mg. If 1 out of 3 patients experiences a DLT, 3 more patients will be added to the 200 mg dose. If no more patients experience a DLT at 200mg, the next 3 patients will receive 300mg. If 2 of 6 patients receiving 200mg experience a DLT, the study will stop. If 2 or more patients experience DLTs, the maximum tolerated dose (MTD) will be the previous dose level. The same process will be repeated at each dose level. There will be 6 patients enrolled at MTD level for a maximum of 12 patients in the phase I cohort. Ladarixin will be administered as a twice-daily dose over a 21 day treatment cycle.
In Phase II, ladarixin will be administered twice-daily at the recommended phase II dose over 21-day cycles.
| Study group | Role | What they receive |
|---|---|---|
| Advanced NSCLC Patients | Experimental | Patients with KRASG12C mutant NSCLC will receive ladarixin and sotorasib in combination. Receives: Drug: Sotorasib; Drug: Ladarixin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs) during 1st Treatment Cycle among Phase I Participants
DLTs are defined as side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
Measured: Up to Day 21 (End Treatment Cycle 1, each cycle is 21 days)
Progression Free Survival (PFS)
PFS is the amount of time (months) from initial treatment to disease progression or death from any cause.
Measured: Up to End of Survival Follow-Up (Up to Month 36)
Secondary outcomes (10)
Percent of Participants who Experience Grade 5 Treatment-Related Adverse Events per CTCAE 5.0
Number of participants whose most severe treatment-related adverse event was rated Grade 5 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, where Grade 5 = death related to adverse event.
Measured: Up to End of Survival Follow-Up (Up to Month 36)
Percent of Participants who Experience Grade 4 Treatment-Related Adverse Events per CTCAE 5.0
Number of participants whose most severe adverse event related to treatment was rated Grade 4 according to CTCAE version 5.0, where Grade 4 = life-threatening consequences; urgent intervention indicated.
Measured: Up to End of Survival Follow-Up (Up to Month 36)
Percent of Participants who Experience Grade 3 Treatment-Related Adverse Events per CTCAE 5.0
Number of participants whose most severe treatment-related adverse event was rated Grade 3 according to CTCAE version 5.0, where Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living (ADL).
Measured: Up to End of Survival Follow-Up (Up to Month 36)
Percent of Participants who Experience Grade 2 Treatment-Related Adverse Events per CTCAE 5.0
Number of participants whose most severe treatment-related adverse event was rated Grade 2 according to CTCAE version 5.0, where Grade 2 = Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL.
Measured: Up to End of Survival Follow-Up (Up to Month 36)
Percent of Participants who Experience Grade 1 Treatment-Related Adverse Events per CTCAE 5.0
Number of participants whose most severe treatment-related adverse event was rated Grade 1 according to CTCAE version 5.0, where Grade 1 = Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL.
Measured: Up to End of Survival Follow-Up (Up to Month 36)
Percent of Participants who Experience Complete Response (CR)
Percent of participants whose best response is a CR according to RECIST 1.1, where CR = disappearance of all target lesions.
Measured: Up to End of Survival Follow-Up (Up to Month 36)
Percent of Participants who Experience Partial Response (PR)
Percent of participants who best response is a PR according to RECIST 1.1, where PR = at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Up to End of Survival Follow-Up (Up to Month 36)
Percent of Participants who Experience Unconfirmed Complete Response (UCR)
Percent of participants who best response is a CR according to RECIST 1.1, but the response has not been confirmed.
Measured: Up to End of Survival Follow-Up (Up to Month 36)
Percent of Participants who Experience Unconfirmed Partial Response (PR)
Percent of participants who best response is a PR according to RECIST 1.1, but the response has not been confirmed.
Measured: Up to End of Survival Follow-Up (Up to Month 36)
Overall Survival (OS)
OS is the amount of time (months) from initial treatment to death due to any cause.
Measured: Up to End of Survival Follow-Up (Up to Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Aug 2023
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non-small Cell Lung Cancer With KRAS G12C MutationStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salman Punekar, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815173
- Sponsor's protocol ID
- 22-00959
- Status last verified
- Dec 2025
- First submitted
- 4 Apr 2023
- Last updated
- 30 Dec 2025
- 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 used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: salman.punekar@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Ladarixin and Sotorasib in Advanced KRAS G12C Mutant Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT05815173
- Acronym / sponsor ID
- 22-00959
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This study will enroll patients with KRASG12C mutant NSCLC not previously treated with KRASG12C inhibitors. Patients in this study will receive ladarixin and sotorasib. The primary objective of the Phase I portion is to define a recommended phase II dose (RP2D) of ladarixin when combined with sotorasib. The primary objective of the Phase II portion is to evaluate progression free survival (PFS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced NSCLC Patients | Experimental | Drug: Sotorasib, Drug: LadarixinPatients with KRASG12C mutant NSCLC will receive ladarixin and sotorasib in combination. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Written informed consent, according to local guidelines, signed and dated by the participant prior to the performance of any study-specific procedures, sampling, or analyses.
- Participant must be ≥18 years of age at the time of signature of the informed consent form (ICF).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Histologically confirmed diagnosis of NSCLC (squamous or nonsquamous).
- Patients with metastatic or locally advanced NSCLC who are not candidates for curative surgery or curative radiation.
Key exclusion criteria (45 listed)
- History (≤1 years) or presence of hematological malignancies except stable CLL.
- History (≤1 years) of other cancer that is histologically distinct from the cancers under study, except for cervical carcinoma in situ, ductal carcinoma in situ, prostatic intraepithelial neoplasia, superficial non-invasive bladder tumors, or curatively treated stage I non-melanoma skin cancer.
- Known serious allergy to ladarixin, sotorasib, or excipients (e.g., microcrystalline cellulose).
- History (≤6 months before the start of treatment with the study drugs) of severe autoimmune disease (including ≥ Grade 3 or recurrent Grade 2 immune-related AEs of prior immuno-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone >10 mg/day or equivalent).
- Brain or spinal metastases, except if treated by surgery or surgery plus radiotherapy or radiotherapy alone, with no clinical evidence of progression or hemorrhage for ≤7 days before the start of treatment with the study drugs, and has not received any systemic corticosteroids for ≥7 days before the start of treatment with the study drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SotorasibSotorasib administered at the approved dose of 960mg PO once daily over 21-day treatment cycles. | Drug | Advanced NSCLC Patients |
| LadarixinLadarixin dose will be escalated as follows in Phase I: 3 patients will receive a starting dose of 200mg. If 2 or more patients experience a DLT at the lowest dose, the study will stop. If 0 out of 3 patients experience a DLT within 28 days, the next 3 patients will receive 300mg. If 1 out of 3 patients experiences a DLT, 3 more patients will be added to the 200 mg dose. If no more patients experience a DLT at 200mg, the next 3 patients will receive 300mg. If 2 of 6 patients receiving 200mg experience a DLT, the study will stop. If 2 or more patients experience DLTs, the maximum tolerated dose (MTD) will be the previous dose level. The same process will be repeated at each dose level. There will be 6 patients enrolled at MTD level for a maximum of 12 patients in the phase I cohort. Ladarixin will be administered as a twice-daily dose over a 21 day treatment cycle. In Phase II, ladarixin will be administered twice-daily at the recommended phase II dose over 21-day cycles. | Drug | Advanced NSCLC Patients |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs) during 1st Treatment Cycle among Phase I Participants
Time frame: Up to Day 21 (End Treatment Cycle 1, each cycle is 21 days)
DLTs are defined as side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
Progression Free Survival (PFS)
Time frame: Up to End of Survival Follow-Up (Up to Month 36)
PFS is the amount of time (months) from initial treatment to disease progression or death from any cause.
10 secondary outcomes
Percent of Participants who Experience Grade 5 Treatment-Related Adverse Events per CTCAE 5.0
Time frame: Up to End of Survival Follow-Up (Up to Month 36)
Percent of Participants who Experience Grade 4 Treatment-Related Adverse Events per CTCAE 5.0
Time frame: Up to End of Survival Follow-Up (Up to Month 36)
Percent of Participants who Experience Grade 3 Treatment-Related Adverse Events per CTCAE 5.0
Time frame: Up to End of Survival Follow-Up (Up to Month 36)
Percent of Participants who Experience Grade 2 Treatment-Related Adverse Events per CTCAE 5.0
Time frame: Up to End of Survival Follow-Up (Up to Month 36)
Percent of Participants who Experience Grade 1 Treatment-Related Adverse Events per CTCAE 5.0
Time frame: Up to End of Survival Follow-Up (Up to Month 36)
Percent of Participants who Experience Complete Response (CR)
Time frame: Up to End of Survival Follow-Up (Up to Month 36)
Percent of Participants who Experience Partial Response (PR)
Time frame: Up to End of Survival Follow-Up (Up to Month 36)
Percent of Participants who Experience Unconfirmed Complete Response (UCR)
Time frame: Up to End of Survival Follow-Up (Up to Month 36)
Percent of Participants who Experience Unconfirmed Partial Response (PR)
Time frame: Up to End of Survival Follow-Up (Up to Month 36)
Overall Survival (OS)
Time frame: Up to End of Survival Follow-Up (Up to Month 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: salman.punekar@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Salman Punekar, MD principal investigator
NYU Langone Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sotorasib and Ladarixin in people with Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation, run by NYU Langone Health at 6 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 22 inclusion and 45 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 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of Dose-Limiting Toxicities (DLTs) during 1st Treatment Cycle among Phase I Participants (time frame: Up to Day 21 (End Treatment Cycle 1, each cycle is 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2025.