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Proteasome Inhibitor

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

Must not have

Active infection requiring antibiotics

Known history of HIV with detectable viral load

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during cycle 1 (each cycle is 28 days)

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking antibiotics for an infection.

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I have HIV with a detectable viral load.

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I couldn't tolerate the drug sotorasib at 240 mg daily.

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I have chronic hepatitis B with a detectable virus level.

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I do not have any uncontrolled serious illnesses.

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I have chronic hepatitis C that has not been treated.

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I do not have severe heart failure, recent heart attack, or uncontrolled heart rhythm problems.

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I do not have another cancer that affects this treatment's safety or results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1 of treatment until the criteria for disease progression is met or until death, assessed up to 30 days after completion of study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 1 of treatment until the criteria for disease progression is met or until death, assessed up to 30 days after completion of study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 of treatment until the criteria for disease progression is met or until death, assessed up to 30 days after completion of study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of dose limiting toxicities

Incidence of grade 3 and 4 treatment-related toxicities

Secondary study objectives

Duration of response

Objective response rate

Overall survival

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Sotorasib

2021

Completed Phase 1

~370

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160