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Compensation: Varies

Number of Visits: Unknown

Duration: Up to 6 years

42 Participants Needed

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

Recruiting at 72 trial locations

Overseen ByAmgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Amgen

Must not be taking: Proton-pump inhibitors, H2 antagonists

Disqualifiers: Small-cell lung cancer, Myocardial infarction, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The main objective of this study is to evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in participants who receive sotorasib at either 960 mg daily or 240 mg daily whose tumors are programmed death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) \< 1% and/or harbor a serine/threonine kinase 11 (STK11) co-mutation, in a subgroup of participants with PD-L1 \< 1% and in a subgroup of participants with STK11 co-mutation.

Will I have to stop taking my current medications?

The trial requires that you stop using proton-pump inhibitors (medications that reduce stomach acid), certain stomach acid reducers, and specific medications that affect liver enzymes. If you're taking any of these, you may need to stop or switch to a different medication.

What data supports the effectiveness of the drug Sotorasib for advanced non-small cell lung cancer?

Sotorasib has shown promising results in treating advanced non-small cell lung cancer (NSCLC) with a specific KRAS mutation (G12C). It was approved by the FDA after demonstrating significant anticancer activity in clinical trials, particularly in patients who had already received other treatments.¹ ² ³ ⁴ ⁵

What safety data exists for Sotorasib in humans?

Sotorasib has been studied in patients with advanced non-small cell lung cancer and has shown a manageable safety profile. Common side effects include diarrhea, muscle pain, nausea, tiredness, liver issues, and cough.¹ ² ⁴ ⁵ ⁶

What makes the drug Sotorasib unique for treating advanced non-small cell lung cancer?

Sotorasib is unique because it is the first drug specifically targeting the KRAS G12C mutation in non-small cell lung cancer, offering a new option for patients who have already tried other treatments. It works by binding to the KRAS G12C protein, blocking signals that promote cancer cell growth, and is taken orally, making it convenient for patients.¹ ² ⁴ ⁶ ⁷

Research Team

Principal Investigator

Amgen

Eligibility Criteria

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.

Inclusion Criteria

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

My cancer is at stage IV and I haven't received treatment for this stage yet.

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

See 4 more

Exclusion Criteria

I have not had radiation therapy in the last 2 weeks.

I am not taking strong medications that affect liver enzymes or certain stomach acid drugs.

I have not had a heart attack in the last 6 months.

See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sotorasib at either 960 mg or 240 mg daily based on their tumor characteristics

Up to 6 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

Sotorasib

Trial OverviewThe 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.

Participant Groups

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.

Sotorasib is already approved in United States, European Union for the following indications:

Approved in United States as Lumakras for:

KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC)

Approved in European Union as Lumakras for:

KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Findings from Research

Sotorasib (LUMAKRAS™) is an innovative treatment specifically targeting KRAS G12C mutations in solid tumors, particularly effective for non-small cell lung cancer (NSCLC) and colorectal cancer.

In May 2021, sotorasib received accelerated approval from the US FDA for adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have undergone at least one prior treatment, marking a significant milestone in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sotorasib: First Approval.Blair, HA.[2022]

In a phase 2 trial involving 126 patients with KRAS p.G12C-mutated advanced non-small-cell lung cancer (NSCLC), sotorasib demonstrated a 37.1% objective response rate, including complete responses in 3.2% of patients, indicating its efficacy in this difficult-to-treat population.

The treatment was associated with a median overall survival of 12.5 months and a median progression-free survival of 6.8 months, with manageable safety profiles, as 69.8% of patients experienced treatment-related adverse events, mostly of grade 3 severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sotorasib for Lung Cancers with KRAS p.G12C Mutation.Skoulidis, F., Li, BT., Dy, GK., et al.[2022]

Sotorasib is the first commercially available KRASG12C inhibitor, showing promise in improving outcomes for patients with KRASG12C-mutated non-small cell lung cancer (NSCLC), which is prevalent among smokers.

Despite its potential, there are ongoing questions about sotorasib's effectiveness in the brain, optimal dosing, and how it compares to standard treatments, highlighting the need for further research on resistance mechanisms and combination therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of sotorasib for the treatment of patients with non-small cell lung cancer with KRASG12C mutations.Strohbehn, GW., Sankar, K., Qin, A., et al.[2022]