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Study of Sotorasib Treatment for First-Line Therapy in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with KRAS G12C Mutation

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 treating patients with Non-small cell lung cancer (NSCLC) that has a specific genetic change called KRAS G12C mutation. The study will test a medication called sotorasib (also known as AMG 510), which is given as tablets taken by mouth. This medication is being studied in patients who have not received previous treatment for their advanced cancer.

The purpose of this research is to evaluate how well sotorasib works in treating lung cancer patients whose tumors have specific characteristics, including a protein marker called PD-L1 and a genetic feature called STK11. The medication will be tested at two different daily doses: 960 mg and 240 mg. During the study, patients will take the medication every day for up to 24 months.

Throughout the study, participants will have their cancer monitored using imaging tests such as computed tomography or magnetic resonance imaging (MRI). The study will track various aspects of the treatment's effectiveness, including how the tumors respond to the medication and how long the response lasts. Patients will also be monitored for any side effects that may occur during treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation
Your eligibility for the study will be confirmed based on having stage IV non-small cell lung cancer (NSCLC) with a specific genetic change called KRAS G12C mutation
Medical tests will check if your cancer has a PD-L1 score less than 1% and/or a specific genetic feature called STK11
Your overall physical condition will be evaluated using a scale called ECOG, which must be 0 or 1
Brain scans will confirm you don't have active cancer spread to the brain
Step 2
Treatment administration
You will receive sotorasib tablets to take by mouth daily
The dose will be either 960 mg or 240 mg once per day
You will need to take the medication consistently at the prescribed dose
Step 3
Monitoring during treatment
Regular imaging scans (CT or MRI) will track how your cancer responds to treatment
Blood tests will check your general health and measure medication levels in your body
Heart monitoring through ECG tests will be performed
Any side effects you experience will be recorded and monitored
Your vital signs will be checked regularly
Step 4
Response assessment
Your scans will be reviewed to measure if the cancer has shrunk (partial response) or disappeared (complete response)
The time it takes for your cancer to respond to treatment will be tracked
The duration of your response to treatment will be monitored
Your overall survival and time without cancer progression will be recorded

Who can join the trial?

8 criteria

Must be at least 18 years old with non-small cell lung cancer
Have untreated Stage IV metastatic disease (cancer that has spread to other parts of the body). Patients who received previous treatment (adjuvant/neoadjuvant therapy) are eligible if it was completed more than 12 months before the cancer spread
Must have confirmed KRAS G12C mutation (a specific genetic change in the tumor)
Must have either: - A PD-L1 score less than 1% (a protein marker on cancer cells) and/or - An STK11 co-mutation (another specific genetic change)
Must have good physical function status (ECOG score of 0 or 1), meaning able to perform daily activities with minimal assistance
Must not have active brain metastases (cancer that has spread to the brain)
Must have measurable disease that can be evaluated using standard tumor measurement criteria (RECIST 1.1)
Both men and women may participate

Who cannot join the trial?

13 criteria

Prior treatment with a KRAS G12C inhibitor (a specific type of cancer medication)
Active brain metastases (cancer that has spread to the brain) that are not stable or require increasing doses of steroids
History of other cancers within the last 3 years, except for successfully treated non-melanoma skin cancer or cervical cancer
Active infections requiring systemic therapy (medications that affect the entire body)
Known active hepatitis B or C infection (liver infections)
Known HIV infection or AIDS-related illness
Significant heart conditions including heart failure, irregular heartbeat, or recent heart attack
Uncontrolled high blood pressure
Major surgery within 4 weeks before starting the study treatment
Current pregnancy or breastfeeding
Any serious medical condition that could interfere with study participation
Unable to swallow oral medications
Known allergies to the study medication or its components

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Verified sites

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

Centre Hospitalier Universitaire De Bordeaux
Verified
Bordeaux, France
Centre hospitalier universitaire de Liege
Verified
Liege, Belgium
Fondazione IRCCS San Gerardo Dei Tintori
Verified
Monza, Italy

Trial locations

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Investigated drugs

Sotorasib (also known as AMG 510) is a medication designed to treat non-small cell lung cancer (NSCLC) that has a specific genetic mutation called KRAS G12C. This medication works by targeting and blocking the abnormal KRAS protein that helps cancer cells grow and spread. It is taken by mouth and is used for patients whose cancer has spread to other parts of the body (Stage IV) and who haven't received previous treatment for their cancer. The medication is particularly studied in patients whose tumors have certain characteristics related to PD-L1 protein levels and STK11 genetic mutations.

Sotorasib

What is already known about the treatment

Sotorasib – An oral medication administered in tablet form that represents a breakthrough in targeted therapy for non-small cell lung cancer (NSCLC), specifically for patients with KRAS G12C mutation. This novel drug works by selectively inhibiting the KRAS G12C protein, effectively blocking cancer cell growth and survival signaling at the molecular level. Sotorasib belongs to the class of targeted cancer therapies known as KRAS inhibitors and has shown significant promise in clinical trials for treating advanced-stage NSCLC patients, particularly those who have tested positive for the KRAS G12C mutation. The medication is typically administered daily in doses of either 240mg or 960mg, representing an important treatment option for patients whose tumors express specific molecular characteristics, including those with low PD-L1 expression or STK11 mutations.

Investigated diseases

Non-small cell lung cancer - A type of lung cancer that begins in the epithelial cells of the lung tissue. It develops when cells in the lungs start to grow uncontrollably, forming tumors that can spread to nearby tissues. The disease typically progresses slowly compared to small cell lung cancer, and often begins in the cells that line the bronchi and parts of the lung such as the bronchioles or alveoli. The condition may affect lung function as tumors grow and can spread to lymph nodes or other organs over time. NSCLC accounts for most lung cancer cases and includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.