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Small Molecule

Sotorasib for Advanced Non-Small Cell Lung Cancer (CodeBreaK201 Trial)

Phase 2

Waitlist Available

Research Sponsored by Amgen

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) score of 0 or 1

Programmed death-ligand 1 (PD-L1) TPS Score < 1% and/or serine/threonine kinase 11 (STK11) co-mutation (local confirmation)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

CodeBreaK201 Trial Summary

This trial is testing a new cancer drug to see if it is effective at treating tumors that have a specific genetic mutation.

Who is the study for?

This trial is for adults with Stage IV NSCLC who have not been treated before, have a specific KRAS mutation (G12C), and either low PD-L1 levels or an STK11 co-mutation. They should be in good physical condition (ECOG score of 0 or 1) and cannot have had certain treatments within specified time frames.Check my eligibility

What is being tested?

The study tests two doses of Sotorasib (960 mg daily or 240 mg daily) to see how well it works on tumors with low PD-L1 levels (<1%) and/or STK11 co-mutations. The effectiveness will be measured by the change in tumor size according to RECIST criteria.See study design

What are the potential side effects?

While the side effects for this trial are not listed here, common side effects of cancer drugs like Sotorasib may include diarrhea, fatigue, nausea, liver issues, coughing, and shortness of breath among others.

CodeBreaK201 Trial Eligibility Criteria

Inclusion Criteria

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer has a PD-L1 score under 1% or an STK11 mutation.

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I am 18 or older with non-small cell lung cancer.

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My lung cancer has a specific KRAS G12C mutation.

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I do not have any active cancer spread to my brain.

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My cancer can be measured by standard criteria.

CodeBreaK201 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (OR)

Secondary outcome measures

Area Under the Plasma Concentration-time Curve (AUC) of Sotorasib

Disease Control Rate

Duration of Reponse (DOR)

+10 more

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

CodeBreaK201 Trial Design

2Treatment groups

Experimental Treatment

Group I: Sotorasib: 960 mg DailyExperimental Treatment1 Intervention

Participants with metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma (KRAS) p.G12C mutation whose tumors express < 1% programmed death-ligand 1 (PD-L1) and/or serine/threonine kinase 11 (STK11) mutation in need of first line treatment will be administered sotorasib 960 mg daily. Participants will be stratified by known presence of STK11 mutation.

Group II: Sotorasib: 240 mg DailyExperimental Treatment1 Intervention

Participants with metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma (KRAS) p.G12C mutation whose tumors express < 1% programmed death-ligand 1 (PD-L1) and/or serine/threonine kinase 11 (STK11) mutation in need of first line treatment will be administered sotorasib 240 mg daily. Participants will be stratified by known presence of STK11 mutation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sotorasib

2021

Completed Phase 1

~370

0 / 6Eligibility criteria met