RecruitingPhase 1NCT05815173

Ladarixin With Sotorasib in Advanced NSCLC

Phase I/II Study of Ladarixin and Sotorasib in Advanced KRAS G12C Mutant Non-Small Cell Lung Cancer (NSCLC)

Sponsor

NYU Langone Health

Enrollment

40 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation

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).

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining two drugs — ladarixin (an experimental anti-inflammatory drug) and sotorasib (a targeted therapy) — works better than sotorasib alone for people with advanced non-small cell lung cancer (NSCLC) that has a specific gene mutation called KRAS G12C. The idea is that reducing inflammation in the tumor may help the targeted therapy work more effectively. **You may be eligible if...** - You are 18 or older - You have been diagnosed with advanced or metastatic NSCLC - Your tumor has the KRAS G12C mutation - You have already tried standard treatments including immunotherapy and chemotherapy - You are in good enough health to carry out daily activities (ECOG 0–1) **You may NOT be eligible if...** - You have certain other cancer types or active brain metastases not yet treated - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding - You have had recent major surgery or serious infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSotorasib

Sotorasib administered at the approved dose of 960mg PO once daily over 21-day treatment cycles.

DRUGLadarixin

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.

Locations(6)

NYU Langone Health

Garden City, New York, United States

NYU Langone Health

Mineola, New York, United States

NYU Langone Health

New Hyde Park, New York, United States

NYU Langone Health

New York, New York, United States

NYU Langone Health

New York, New York, United States

NYU Langone Health

New York, New York, United States

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NCT05815173