Study on Sotorasib for Patients with Advanced KRAS G12C-Mutated Non-Small Cell Lung Cancer and Comorbidities

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as KRAS G12C-mutated non-small cell lung cancer. This is a specific form of lung cancer that has a particular genetic mutation called KRAS G12C. The trial is testing a medication called sotorasib, which is taken as a film-coated tablet. Sotorasib is an enzyme inhibitor, meaning it works by blocking certain proteins that help cancer cells grow.

The purpose of the study is to see how effective sotorasib is in reducing the size of tumors in patients with this type of lung cancer. Participants in the study will receive sotorasib and will be monitored over time to observe changes in their tumor size and overall health. The study will also look at how long patients can live without their disease getting worse and how long they respond to the treatment. Some patients may receive a placebo, which is a substance with no active medication, to compare the effects of sotorasib.

Throughout the study, various health assessments will be conducted to ensure the safety and well-being of the participants. These assessments will include monitoring for any side effects, changes in vital signs, and laboratory tests. The study aims to gather information on how sotorasib affects patients with different health conditions and how it interacts with other treatments they may have received. The trial is expected to continue until 2028, providing valuable insights into the treatment of KRAS G12C-mutated non-small cell lung cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

Laboratory tests are performed to ensure adequate bone marrow and organ function. These tests include blood counts and liver function tests.

A biopsy may be required to confirm the presence of the KRAS G12C mutation in the lung cancer tissue.

2 treatment initiation

The treatment involves taking sotorasib orally. The dosage and frequency are determined by the study protocol.

The main objective is to evaluate the effectiveness of sotorasib in reducing tumor size.

3 monitoring and follow-up

Regular follow-up visits are scheduled to monitor the response to treatment. This includes imaging tests to measure tumor size and assess any changes.

Blood tests are conducted to monitor for any side effects and to evaluate overall health.

4 evaluation of response

The primary endpoint is the Objective Response Rate (ORR), which measures the percentage of patients whose tumors shrink or disappear after treatment.

Secondary endpoints include progression-free survival, duration of response, and overall survival.

5 completion of study

The study is estimated to end by June 2028. At the end of the study, a final assessment is conducted to evaluate the overall effectiveness and safety of the treatment.

Participants may be asked to provide feedback on their experience and any changes in symptoms or quality of life.

Who Can Join the Study?

Provide a signed and dated written consent form to participate.
Have a mean resting corrected QT interval (QTc) of less than 470 milliseconds for females or less than 450 milliseconds for males. This is a measure of heart rhythm.
Have enough healthy bone marrow or organ function, shown by specific blood test results.
Be over 18 years old.
Have a confirmed diagnosis of non-small cell lung cancer (NSCLC) at stage III or IV, which cannot be treated with the aim of curing it. If you had treatment for non-metastatic disease before, a new biopsy is needed unless a recent one is available.
Have a documented KRAS G12C mutation in the cancer tissue, confirmed by a reliable method.
Have received at least one previous treatment for NSCLC stage III or IV that did not work or the disease came back. This treatment must have included a checkpoint inhibitor, unless there is a medical reason not to use it.
Have an ECOG status of 0 to 2, which is a scale to measure daily living abilities, and a life expectancy of at least 12 weeks.
Have at least one tumor that has not been treated with radiation and can be measured accurately at the start of the study. Brain tumors are not considered measurable.
Females must use effective birth control, not be breastfeeding, and have a negative pregnancy test if they can have children. If they cannot have children, they must meet certain criteria, such as being post-menopausal or having had certain surgeries.
Male participants must agree to use barrier contraception, like condoms.

Who Cannot Join the Study?

Patients who do not have KRAS G12C-mutated non-small cell lung cancer cannot participate. This is a specific type of lung cancer with a particular genetic change.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Both male and female patients are eligible, so gender is not a reason for exclusion.
Patients who are considered part of a vulnerable population are not excluded. This means that groups who might need special protection are not automatically excluded.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Oslo University Hospital HF	Oslo	Norway
Universitetssykehuset Nord-Norge HF	Tromsø	Norway
Odense University Hospital	Odense	Denmark
Vestre Viken HF	Drammen	Norway
Karolinska University Hospital	Solna	Sweden
St. Olavs Hospital HF	Trondheim	Norway
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Hsshx Fpxuv Hs	Haugesund	Norway
Hqbnu Sfaqbwows Hy	Stavanger	Norway
Aqfonfmb Uokepfyues Hhsqgniq	Lorenskog	Norway
Hktfw Bnndhr Hp	Bergen	Norway

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.08.2021
Norway	Recruiting	01.08.2021
Sweden	Recruiting	01.08.2021

Trial locations

Investigated drugs:

Sotorasib

Sotorasib is a medication being studied for its ability to reduce tumor size in patients with advanced non-small cell lung cancer that has a specific mutation known as KRAS G12C. This medication is designed to target and inhibit the activity of the mutated KRAS protein, which is involved in the growth and survival of cancer cells. By blocking this protein, sotorasib aims to slow down or stop the progression of the cancer.

KRAS G12C-mutated non-small cell lung cancer – This is a type of lung cancer characterized by a specific genetic mutation in the KRAS gene, known as G12C. It primarily affects the cells lining the lungs and is a subtype of non-small cell lung cancer, which is the most common form of lung cancer. The disease progresses as the mutated cells grow uncontrollably, forming tumors that can spread to other parts of the body. This mutation-driven cancer can lead to symptoms such as persistent cough, chest pain, and difficulty breathing as the tumors grow and affect lung function. The progression of the disease can vary, with some patients experiencing rapid growth of tumors, while others may have a slower progression. Understanding the specific mutation helps in targeting treatments that can potentially slow down or reduce tumor growth.

Trial ID:

2023-503174-20-00

Protocol code:

20207314

NCT ID:

NCT05311709

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Sotorasib for Patients with Advanced KRAS G12C-Mutated Non-Small Cell Lung Cancer and Comorbidities

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?