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New treatment option for Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation
Official title Ladarixin With Sotorasib in Advanced NSCLC
ClinicalTrials.gov ID: NCT05815173
What this study is testing
What is Sotorasib?
Sotorasib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for advanced non-small cell lung cancer with kras g12c mutation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Written informed consent, according to local guidelines, signed and dated by the participant prior to the performance of any study-specific...
- 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.
You likely can't join if
- 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...
- 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...
- Brain or spinal metastases, except if treated by surgery or surgery plus radiotherapy or radiotherapy alone, with no clinical evidence of progression...
- History (≤6 months before the start of treatment with the study drugs) of pericarditis (any grade) or pericardial effusion (Grade ≥2).
See the full eligibility criteria
Who can 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...
- 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...
- 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 people 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...
- 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...
- Participants must be able to swallow and retain orally administered medication.
What rules you out
- 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...
- 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...
- 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...
- History (≤6 months before the start of treatment with the study drugs) of pericarditis (any grade) or pericardial effusion (Grade ≥2).
- 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...
- 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...
- 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)...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Garden City, New York, United States
- Mineola, New York, United States
- New Hyde Park, New York, United States
- New York, New York, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Garden City, New York, United States; Mineola, New York, United States; New Hyde Park, New York, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.