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KRAS G12C Inhibitor

Sotorasib for Lung Cancer

Phase 2

Recruiting

Led By Gregory Riely, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Karnofsky performance status (KPS) ≥ 70%

Age ≥ 18

Must not have

Other clinically active or chronic liver disease

Use of P-gp substrates

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 6 month of therapy

Awards & highlights

Summary

This trial is testing if sotorasib is a safe and effective treatment for people with advanced non-small cell lung cancer who have a specific genetic mutation and have not received treatment for their cancer since it

Who is the study for?

This trial is for individuals with advanced non-small cell lung cancer (NSCLC) that has a specific mutation called KRAS G12C. Participants should not have received any first-line therapy since their cancer became advanced.

What is being tested?

The study is testing the safety and effectiveness of a drug named Sotorasib in treating NSCLC with the KRAS G12C mutation. It aims to understand if this drug can be an effective treatment option.

What are the potential side effects?

While the side effects of Sotorasib are not detailed here, similar medications often cause issues like nausea, diarrhea, fatigue, liver enzyme elevation, and potential skin problems.

Eligibility Criteria

Inclusion Criteria

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

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I am able to care for myself but may not be able to do active work.

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I am 18 years old or older.

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My lung cancer has spread or come back.

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My cancer has the KRAS G12C mutation.

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I have not received any treatments for my condition in its advanced stage.

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My blood and organ tests meet the required levels for treatment.

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I chose not to have first-line chemotherapy or immunotherapy, or my early-stage lung cancer worsened after such treatments.

Exclusion Criteria

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

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I do not have any active or chronic liver diseases.

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I am taking medication that is a P-gp substrate.

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I have brain metastases that cause symptoms.

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I have not had any radiation therapy in the week before starting the treatment.

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I have not had major surgery within the last week.

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I have no major side effects from past treatments.

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I have had lung inflammation from treatment that was mild or worse.

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I can take oral medication and do not have severe GI issues.

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I am not taking medication that strongly activates CYP3A4.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 6 month of therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 6 month of therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 6 month of therapy for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Response to therapy

Side effects data

From 2022 Phase 1 trial • 20 Patients • NCT04887064

14%

Constipation

100%

80%

60%

40%

20%

Study treatment Arm

Normal Hepatic Function

Moderate Hepatic Impairment

Severe Hepatic Impairment

Trial Design

1Treatment groups

Experimental Treatment

Group I: SotorasibExperimental Treatment1 Intervention

All patients will start at sotorasib 960 mg (8 pills) daily within 7 days of completion of the pretreatment tumor biopsy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sotorasib

2021

Completed Phase 1

~370

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,956 Previous Clinical Trials

595,517 Total Patients Enrolled

Gregory Riely, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer

4 Previous Clinical Trials

118 Total Patients Enrolled

~26 spots leftby Aug 2026

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