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Proteasome Inhibitor

Treatment (carfilzomib, sotorasib) for Lung Cancer

Phase 1

Recruiting

Led By Ravi Salgia, MD

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Creatinine clearance of ≤ 1.5 x ULN or GFR ≥ 60 mL/min/1.73 m^2

Failed prior KRAS inhibitor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of treatment until disease progression/recurrence, assessed up to 30 days after completion of study treatment

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of using a combination of two drugs, carfilzomib and sotorasib, to treat patients with a specific type of lung cancer called KRAS

Who is the study for?

This trial is for adults with advanced or metastatic non-small cell lung cancer that has a specific mutation called KRAS G12C. Participants should have measurable disease and may have had prior treatments, but there are certain criteria they must meet to join.Check my eligibility

What is being tested?

The trial is testing the combination of two drugs, Carfilzomib and Sotorasib, to see if they're safe together, what the best dose might be, and how well they work against this type of lung cancer. It includes tests like CT scans, MRIs, biopsies, and heart checks.See study design

What are the potential side effects?

Possible side effects from Carfilzomib could include fatigue, nausea, shortness of breath among others. Sotorasib may cause diarrhea or liver issues. The study will monitor patients closely for any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is within the normal range.

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I have tried a KRAS inhibitor treatment without success.

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My heart function is classified as good or better.

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I am able to get out of my bed or chair and move around.

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I am 18 years old or older.

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My lung cancer is advanced or has spread, and tests show a KRASG12C mutation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from treatment response to progression or death, assessed up to 30 days after completion of study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from treatment response to progression or death, assessed up to 30 days after completion of study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and from treatment response to progression or death, assessed up to 30 days after completion of study treatment for reporting.

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

Incidence of grade 3 and 4 treatment-related toxicities

Secondary outcome measures

Duration of response

Objective response rate

Overall survival

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (carfilzomib, sotorasib)Experimental Treatment7 Interventions

Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16 of each cycle and sotorasib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO at screening and undergo CT or MRI and collection of blood samples at screening and on study. Patients may undergo optional biopsies on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1090

Carfilzomib

2017

Completed Phase 3

~1440

Echocardiography

2013

Completed Phase 4

~11670

Sotorasib

2021

Completed Phase 1

~370

Computed Tomography

2017

Completed Phase 2

~2720

Biospecimen Collection

2004

Completed Phase 2

~1700

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,669 Previous Clinical Trials

40,926,386 Total Patients Enrolled

City of Hope Medical CenterLead Sponsor

567 Previous Clinical Trials

1,922,645 Total Patients Enrolled

Ravi Salgia, MDPrincipal InvestigatorCity of Hope Medical Center

2 Previous Clinical Trials

42 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA formally endorsed the use of carfilzomib and sotorasib for treatment?

"Based on our assessment at Power, the safety rating for Treatment (carfilzomib, sotorasib) is 1. This score reflects that this Phase 1 trial has minimal data supporting its safety and effectiveness."

Answered by AI

Is the enrollment for this clinical trial currently open?

"As per clinicaltrials.gov, patient recruitment is not ongoing for this particular trial. The trial was introduced on April 17th, 2024 and saw its latest update on February 6th, 2024. Presently, there are approximately 4180 other trials that are actively enrolling participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Carfilzomib in Combination With Sotorasib for the Treatment of Patients With KRAS G12C Mutated Advanced or Metastatic Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06249282.

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