RecruitingPhase 1NCT06249282

Carfilzomib in Combination With Sotorasib for the Treatment of Patients With KRAS G12C Mutated Advanced or Metastatic Non-small Cell Lung Cancer

A Phase I Clinical Trial of Carfilzomib in Combination With Sotorasib in Patients With KRASG12C Mutated Advanced Non-Small Cell Lung Cancer

Sponsor

City of Hope Medical Center

Enrollment

15 participants

Start Date

Apr 24, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Lung Non-Small Cell Carcinoma Stage III Lung Cancer AJCC v8 Stage IV Lung Cancer AJCC v8 Advanced Lung Non-Small Cell Carcinoma

Summary

This phase I trial tests the safety, side effects, and best dose of carfilzomib in combination with sotorasib in treating patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Carfilzomib is a drug that binds to and inhibits the activity of the protein complex that is responsible for degrading other damaged or unneeded proteins. The inhibition of this protein by carfilzomib can then cause tumor growth inhibition and cell death. Sotorasib is a drug that binds to and inhibits the activity of the KRAS G12C mutant. This may inhibit growth in KRAS G12C-expressing tumor cells. Combining carfilzomib and sotorasib may be a safe and effective treatment option for patients with KRAS G12C-mutated advanced or metastatic NSCLC.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining two targeted drugs — sotorasib (a KRAS G12C inhibitor) and carfilzomib (a proteasome inhibitor) — can overcome resistance to KRAS-targeted therapy in people with advanced non-small cell lung cancer (NSCLC) that has the KRAS G12C mutation and has stopped responding to a prior KRAS inhibitor. **You may be eligible if...** - You are 18 or older - You have confirmed advanced or metastatic NSCLC with a KRAS G12C mutation - Your cancer has progressed after treatment with a prior KRAS inhibitor - You are in reasonably good physical condition - You have adequate heart, liver, and kidney function **You may NOT be eligible if...** - You have not yet tried a KRAS inhibitor - You have significant heart problems - You have uncontrolled brain metastases - You are pregnant or breastfeeding - You have not recovered from side effects of prior treatments 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

PROCEDUREBiopsy

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

DRUGCarfilzomib

Given IV

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREEchocardiography

Undergo ECHO

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

DRUGSotorasib

Given PO

Locations(2)

City of Hope Medical Center

Duarte, California, United States

City of Hope at Irvine Lennar

Irvine, California, United States

View Full Details on ClinicalTrials.gov

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NCT06249282

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