Study of Sotorasib Treatment in Patients with Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with KRAS G12C Mutation Who Have Previously Received Treatment

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What is this study about?

This study focuses on non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic) or is locally advanced and cannot be surgically removed. Specifically, it looks at cases where the cancer has a particular genetic change called KRAS G12C mutation. The study will use a medication called sotorasib (also known as LUMYKRAS or AMG 510), which is given as tablets taken by mouth.

The purpose of this research is to understand how tumors respond to treatment after 4 months and to identify biological markers that might explain why some patients stop responding to the treatment. The study will involve patients who have already received at least one previous treatment for their advanced lung cancer.

During the study, participants will take sotorasib tablets daily. They will have regular medical check-ups and imaging scans every 8 weeks to monitor how their cancer responds to treatment. The study also includes collecting tissue samples before, during, and after treatment to better understand how the medication works and why some cancers might become resistant to it.

1 Initial medication start

You will receive sotorasib (LUMYKRAS) as film-coated tablets

The medication is taken by mouth in a dose of 120 mg

Your doctor will provide specific instructions about when to take the medication

2 Regular tumor assessment

Your tumor will be evaluated every 8 weeks using imaging scans

The doctor will measure how your tumor responds to treatment

If initial positive results are seen, a confirmation scan will be done after 4 weeks

3 Tumor tissue sampling

Tissue samples will be taken at three points during the study:

Before starting treatment

During the treatment period

At the end of treatment

4 Ongoing monitoring

Regular check-ups to monitor your health status

Blood tests to check your bone marrow and organ function

Assessment of any side effects or health changes

5 Follow-up period

Your health status will continue to be monitored after treatment

The study will track how long the treatment remains effective

Follow-up will continue until June 2027 or earlier if specified by your doctor

Who Can Join the Study?

  • Must be at least 18 years old
  • Must have health insurance coverage through a Social Security System
  • Must have good physical performance status (ECOG score of 0 or 1, meaning able to carry out light daily activities)
  • Must have advanced lung cancer that cannot be surgically removed or has spread to other parts of the body (NSCLC) with a specific genetic mutation called KRAS G12C
  • Must have received at least one previous treatment for advanced cancer and experienced disease progression or recurrence
  • Must have a life expectancy of more than 3 months as determined by the doctor
  • Must have tumors that can be easily biopsied and agree to undergo biopsies before, during, and after treatment
  • Must have adequate bone marrow and organ function based on laboratory tests performed within 14 days before joining the study
  • Must be able to read, understand, and sign the informed consent form before any study procedures begin
  • Must be willing and able to attend all required study visits and follow study procedures

Who Cannot Join the Study?

  • History of treatment with a KRAS G12C inhibitor (a type of targeted cancer therapy)
  • Active brain metastases (cancer that has spread to the brain) that are not treated and stable
  • Known hypersensitivity (severe allergic reaction) to sotorasib or its components
  • Pregnant or breastfeeding women
  • Significant heart conditions, including:
    • Uncontrolled high blood pressure
    • Unstable heart disease
    • Heart attack within the last 6 months
  • Active infections requiring systemic treatment (medications that affect the entire body)
  • Other active cancers requiring treatment (except for certain skin cancers or in situ cervical cancer)
  • Severe liver dysfunction
  • Severe kidney disease requiring dialysis
  • Any medical condition that could interfere with the safe administration of the study treatment
  • Unable to swallow oral medications
  • Participation in another clinical trial within 30 days before starting this study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France

Other Sites

Site Name City Country Status
Hopital Tenon Paris France
Cmvxkm Ljyq Bfiduw Lyon France
Hvzflfx Hgdxz Mcuwos &ofirwn 1 reo Gipzfnf Eppzyv Creteil France
Gdfgwk Halsoniropb Urjcoboarxvby Pwvqs Pxadebfmnob Eg Nacykeouwjrc Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
13.12.2022

Trial locations

Investigated drugs:

Sotorasib is a targeted therapy medication used to treat non-small cell lung cancer (NSCLC) that has a specific genetic mutation called KRAS p.G12C. This medication works by blocking the abnormal KRAS protein that helps cancer cells grow and spread. It is used in patients who have already received previous treatment for their locally advanced or metastatic lung cancer. The medication is taken orally and is designed to specifically target cancer cells with this particular genetic mutation, potentially leading to fewer side effects compared to traditional chemotherapy.

Investigated diseases:

Non-small Cell Lung Cancer (NSCLC) – A type of lung cancer that begins in the cells of the lungs and can spread to other parts of the body. NSCLC specifically with KRAS G12C mutation is a distinct form where there is a specific change in the KRAS gene at position G12C. This cancer typically starts in the outer parts of the lungs in the cells that line the airways. The disease can progress from a localized form to become locally advanced, where it grows into nearby structures, or metastatic, where it spreads to distant parts of the body. In its advanced stages, the cancer can grow into nearby tissues and form tumors in other organs.

Trial ID:
2024-510837-16-00
Protocol code:
2021/3401
Trial Phase:
Therapeutic exploratory (Phase II)

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