Study on JDQ443 for Patients with KRAS G12C+ Non-Small Cell Lung Cancer and Brain Metastases

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as non-small cell lung cancer (NSCLC) that has a specific mutation called KRAS G12C. The study also involves patients whose cancer has spread to the brain, known as brain metastases. The treatment being tested is a medication called JDQ443, which is taken in tablet form. The purpose of the study is to evaluate how well JDQ443 works in treating brain metastases in these patients.

Participants in the study will receive JDQ443 and will be monitored to see how their brain metastases respond to the treatment. The study will look at how the cancer in the brain changes over time and whether the treatment can control the disease. The study will also assess the overall health and quality of life of the participants during the treatment period.

The study will last for a period of up to 12 months, during which participants will take the medication and undergo regular check-ups to monitor their condition. The results will help determine the effectiveness of JDQ443 in treating brain metastases in patients with KRAS G12C-positive NSCLC. This research aims to provide valuable information that could lead to better treatment options for patients with this type of cancer.

1 initial assessment

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

Laboratory tests are performed to ensure adequate organ function. These tests measure blood cell counts, liver enzymes, and kidney function, among others.

2 medication administration

The study involves taking a medication called JDQ443, which is provided in tablet form for oral use.

The dosage and frequency of JDQ443 are determined by the study protocol and are explained during the initial assessment.

3 monitoring and follow-up

Regular follow-up visits are scheduled to monitor the response to the medication and any side effects.

These visits include physical examinations, imaging tests, and additional laboratory tests to assess the impact of the treatment on brain metastases and overall health.

4 evaluation of treatment response

The primary goal is to evaluate the response of brain metastases to JDQ443 using specific criteria.

Secondary evaluations include assessing disease control, progression-free survival, and overall survival.

5 quality of life assessment

Throughout the study, quality of life is assessed using standardized questionnaires.

These assessments help understand the impact of the treatment on daily living and well-being.

6 completion of study

The study is expected to continue until August 2027, with individual participation duration varying based on response and health status.

Upon completion, a final assessment is conducted to summarize the treatment outcomes and any long-term effects.

Who Can Join the Study?

You must sign a form agreeing to participate in the study.
Your body organs must be working well, shown by certain blood test results:
- Absolute neutrophil count (ANC) should be at least 1.5 x 10⁹/L without help from growth factors.
- Platelets should be at least 100 x 10⁹/L without help from growth factors.
- Hemoglobin (Hgb) should be at least 6 mmol/L (equal to 9 g/dL) without blood transfusions or growth factor help for 7 days.
- Aspartate transaminase (AST) should be no more than 3 times the upper limit of normal (ULN).
- Alanine transaminase (ALT) should be no more than 3 times the ULN.
- Total bilirubin should be no more than 1.5 times the ULN.
- Serum lipase should be no more than 1.5 times the ULN.
- Creatinine clearance should be at least 60 mL/min, which shows how well your kidneys are working.
You must be able to swallow the study medication and follow instructions for taking it.
You must be able to talk with the study doctor and follow the study procedures.
You must be an adult, 18 years or older, when you agree to join the study.
Your ECOG performance status should be 2 or less, which means you are able to do daily activities with some help.
You should have an expected life span of at least 12 weeks.
You must have stage IV non-small cell lung cancer (NSCLC) with a specific gene change called KRAS G12C mutation and either untreated or growing brain metastases (cohort A) or treated and stable brain metastases (cohort B).
Your brain metastases should not be in important areas of the brain. You should discuss this with a brain specialist, and if treated with radiation and stable, you can join cohort B.
For cohort A, each brain metastasis should be no larger than 2 cm in its longest part.
For cohort A, you must have at least one untreated brain metastasis that is 5 mm or larger:
- If the largest brain lesion is between 5 mm and 10 mm, you may join with the study doctor’s approval, and a special brain scan is needed.
- Previous local treatment is allowed if it was finished at least 14 days before joining the study and the lesion has clearly grown or new lesions have appeared.
- For at least 7 days before the first dose of the study drug, you must not have symptoms from brain metastases and be on a stable dose of steroids, with a maximum of 4 mg of dexamethasone per day. Any anti-seizure medication should also be stable for 7 days.
You must have recovered from any side effects of previous treatments to a mild level (grade 1 or less), except for hair loss and skin color changes, which can be any level.

Who Cannot Join the Study?

Patients who do not have KRAS G12C+ non-small cell lung cancer. This is a specific type of lung cancer with a particular genetic change.
Patients without brain metastases. This means the cancer has not spread to the brain.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
Academisch Ziekenhuis Leiden	Leiden	The Netherlands
Netherlands Cancer Institute	Amsterdam	The Netherlands
Szvjevcbv Rtiktzz Uiiniyyiul Mwytsai Cwvxda	Nijmegen	The Netherlands
Eoifhml Ujrzcfxhbcyn Mjhtlmz Ciamjhp Rkghdkqlc (akbrpef Mpk	Rotterdam	The Netherlands
Urcvvpajohpm Mvawhew Caqrqez Gqghllbvt	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	30.11.2023

Trial locations

Investigated drugs:

1-{6-[(4M)-4-(5-Chloro-6-Methyl-1H -Indazol-4-Yl)-5-Methyl-3-(1-Methyl-1H -Indazol-5-Yl)-1H -Pyrazol-1-Yl]-2-Azaspiro[3.3]Heptan-2-Yl}Prop-2-En-1-One

JDQ443 is an investigational medication being studied for its effectiveness in treating patients with a specific type of lung cancer known as KRAS G12C+ non-small cell lung cancer (NSCLC) that has spread to the brain. The trial aims to assess how well this medication works in shrinking or controlling brain metastases, which are cancerous growths that have spread to the brain from the original lung cancer site.

Investigated diseases:

Non-Small Cell Lung Cancer with KRAS G12C Mutation – This is a type of lung cancer characterized by the presence of a specific genetic mutation known as KRAS G12C. It is the most common form of lung cancer, accounting for about 85% of all lung cancer cases. The disease typically begins in the cells lining the lungs and can spread to other parts of the body. The KRAS G12C mutation leads to uncontrolled cell growth and division, contributing to cancer progression. Over time, the cancer can invade nearby tissues and organs, potentially leading to the development of metastases, including in the brain. The progression of the disease can vary, with some patients experiencing rapid advancement while others may have a slower course.

Brain Metastases – This condition occurs when cancer cells spread from their original site to the brain. It is a common complication of cancers such as lung, breast, and melanoma. Brain metastases can cause a variety of neurological symptoms depending on their size and location within the brain. These symptoms may include headaches, seizures, and changes in cognitive or motor functions. The progression of brain metastases can lead to increased pressure within the skull and further neurological impairment. The growth and impact of these metastases can vary widely among individuals.

Trial ID:

2023-505721-13-00

Protocol code:

CJDQ443B1NL01T

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on JDQ443 for Patients with KRAS G12C+ Non-Small Cell Lung Cancer and Brain Metastases

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?