Not recruiting

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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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
Step 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
Step 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
Step 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 trial?

10 criteria

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 trial?

14 criteria

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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centre Leon Berard
Lyon, France
Verified
Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
Paris, France
Verified
Hopital Henri Mondor - 1 rue Gustave Eiffel
Creteil, France

Trial locations

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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.

Sotorasib

What is already known about the treatment

Sotorasib - A targeted therapy medication administered orally for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with a specific KRAS G12C mutation. This novel drug works by selectively inhibiting the KRAS G12C protein, which is responsible for cancer cell growth and survival, effectively blocking the signals that drive tumor growth. Sotorasib belongs to the class of selective KRAS G12C inhibitors and represents a significant advancement in precision medicine for lung cancer treatment, particularly for patients who have received previous treatment and have this specific genetic mutation. The medication has shown promising results in clinical trials and has received regulatory approval for treating this specific type of lung cancer.

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.