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

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What is this study about?

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.

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

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

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

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Centre hospitalier universitaire de Liege	Liege	Belgium
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Region Gaevleborg	Gavle	Sweden
Isvdbl Imwmpxnb Ffufzujengiut Owuuhgmeaff	Rome	Italy

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	09.02.2022
France	Not recruiting	09.02.2022
Italy	Not recruiting	09.02.2022
Spain	Not recruiting	09.02.2022
Sweden	Not recruiting	09.02.2022

Trial locations

Investigated drugs:

Sotorasib

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.

Investigated diseases:

Non-small cell lung cancer stage IV

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.

Trial ID:

2024-511189-36-00

Protocol code:

20190288

NCT ID:

NCT04933695

Trial Phase:

Therapeutic exploratory (Phase II)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?