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CXC Chemokine Receptor Antagonist
Ladarixin + Sotorasib for Advanced Non-Small Cell Lung Cancer
Phase 1
Recruiting
Led By Salman Punekar, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to end of survival follow-up (up to month 36
Awards & highlights
Study Summary
This trial studies a new drug combo to treat advanced lung cancer with a certain genetic mutation.
Who is the study for?
Adults with advanced non-small cell lung cancer (NSCLC) that has a specific mutation called KRASG12C can join this trial if their disease worsened after anti-PD-1 therapy and/or chemotherapy. They must be able to take pills, have no serious heart issues or infections, not be pregnant or breastfeeding, agree to use contraception, and cannot have had certain other treatments recently.Check my eligibility
What is being tested?
The study is testing the combination of two oral drugs: ladarixin and sotorasib. It's for patients whose NSCLC carries the KRASG12C mutation. The trial aims to see how well these drugs work together when taken twice daily by people who've already tried some other treatments.See study design
What are the potential side effects?
Possible side effects from ladarixin and sotorasib may include digestive problems, liver issues, fatigue, skin reactions, eye problems like inflammation or retinopathy. There might also be risks of developing infections due to immune system effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am fully active or can carry out light work.
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My lung cancer cannot be cured with surgery or radiation.
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My cancer progressed after treatment with anti-PD(L)-1, with or without chemo.
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My lung cancer diagnosis has been confirmed by a lab test.
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I can swallow and keep down pills.
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My tumor has the KRASG12C mutation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to end of survival follow-up (up to month 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to end of survival follow-up (up to month 36
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Dose-Limiting Toxicities (DLTs) during 1st Treatment Cycle among Phase I Participants
Progression Free Survival (PFS)
Secondary outcome measures
Overall Survival (OS)
Percent of Participants who Experience Complete Response (CR)
Percent of Participants who Experience Grade 1 Treatment-Related Adverse Events per CTCAE 5.0
+7 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Advanced NSCLC PatientsExperimental Treatment2 Interventions
Patients with KRASG12C mutant NSCLC will receive ladarixin and sotorasib in combination.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ladarixin
2016
Completed Phase 2
~120
Sotorasib
2021
Completed Phase 1
~370
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,558 Total Patients Enrolled
Salman Punekar, MDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with KRAS inhibitors before.I am 18 years old or older.My brain or spinal cancer has been stable for at least 7 days, and I haven't taken steroids in the last 7 days.I have had lung conditions that needed steroid treatment.I haven't taken any acid-reducing medicines in the last 3 days or 5 half-lives before starting ladarixin.You are allergic to the main ingredient or other ingredients in the study drug, or to non-steroidal anti-inflammatory drugs.I haven't taken any medications known to cause heart rhythm problems in the last 2 weeks.I haven't had major surgery or trauma in the last 28 days and don't expect to need surgery until my treatment ends.I am fully active or can carry out light work.I have heart problems that affect my daily activities.I am not taking medications that are sensitive to changes in how they are broken down by my body.I haven't taken any cancer drugs or experimental drugs within the last month.I haven't taken any strong medication that affects liver enzymes in the last 14 days.I have not had radiation therapy in the week before starting ladarixin.I have a severe autoimmune disease or need long-term steroids.I started treatments like erythropoietin or G-CSF less than 2 weeks before beginning the study drug.My lung cancer cannot be cured with surgery or radiation.My cancer progressed after treatment with anti-PD(L)-1, with or without chemo.I have side effects from previous treatments that are not severe.You have tested positive for HIV antibodies before starting treatment.I have had a bone marrow or organ transplant from another person.I haven't taken any strong herbal drugs or supplements that affect liver enzymes in the last 14 days.I do not have an active infection needing treatment or have completed a 7-day break after antibiotics.My lung cancer diagnosis has been confirmed by a lab test.I have had a different type of cancer within the last year, not including certain exceptions.I have not had any blood cancer, except stable CLL, in the last year.I have had pericarditis or fluid around my heart in the last 6 months.I have had serious eye inflammation or related conditions in the last 6 months.I have not received a live vaccine within 30 days before starting the study medication.I have not had a blood or platelet transfusion in the last week.I have at least one tumor that can be measured by medical imaging.I can swallow and keep down pills.My tumor has the KRASG12C mutation.I will follow the study's birth control requirements.I have had a blockage in my bile ducts due to cancer within the last 6 months, but I have a working biliary stent.You have a neuromuscular disorder that causes high levels of creatine kinase (CK) in your body.Your blood test results at the screening need to meet certain standards for white blood cells, platelets, hemoglobin, albumin, lymphocytes, bilirubin, liver enzymes, blood clotting, and kidney function.I have an active hepatitis B or C infection.I am not allergic to ladarixin, sotorasib, or their ingredients.
Research Study Groups:
This trial has the following groups:- Group 1: Advanced NSCLC Patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any limitations on who is eligible to participate in this research?
"The requirements for this medical trial are: non-small cell lung cancer, ages between 18 and 100 years old. At the moment, 12 participants have been enrolled in the study."
Answered by AI
Does the study allow those aged 40 and greater to participate?
"Participants in this trial should be between the ages of 18 and 100. For those under 18, there are 42 studies available while 1913 have been earmarked for patients above 65 years old."
Answered by AI
What risks do individuals with advanced non-small cell lung cancer face?
"The safety of Advanced NSCLC Patients has been rated a 1 due to the Phase 1 status of this trial, demonstrating there is limited clinical evidence supporting its efficacy and security."
Answered by AI
Is this experiment presently recruiting participants?
"As per clinicaltrials.gov, this particular medical trial is no longer recruiting patients. Originally posted on April 1st 2023 and most recently updated on the 4th of April, there are 1921 other trials currently accepting patient applications as well."
Answered by AI
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