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Study on Brigatinib for Patients with ALK+ Non-Small Cell Lung Cancer

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What is this trial about?

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

This clinical trial is focused on studying a type of lung cancer known as ALK-positive non-small cell lung cancer. The treatment being investigated is a medication called brigatinib, which is taken in the form of film-coated tablets. The purpose of the study is to understand how patients with this specific type of lung cancer respond to brigatinib treatment.

Participants in the study will receive brigatinib and their response to the treatment will be monitored over time. The study will look at how well the cancer responds to the medication, including how long the response lasts and how the treatment affects cancer that may have spread to the brain. The safety and tolerability of brigatinib will also be assessed to ensure it is safe for patients to use.

The study will involve regular check-ups and assessments to track the progress of the treatment. This will help researchers gather important information about the effectiveness of brigatinib in treating ALK-positive non-small cell lung cancer and its impact on patients' overall health and survival. The study is expected to continue until 2027, providing valuable insights into the treatment of this type of lung cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and previous treatments.
A written informed consent is required, acknowledging the investigational nature of the study.
Step 2
Initial assessment
An initial health assessment is conducted, including a review of medical history and a physical examination.
Baseline measurements are taken, including imaging tests to identify measurable lesions.
Step 3
Treatment initiation
The treatment involves taking Alunbrig 30 mg film-coated tablets, which contain the active substance brigatinib.
The medication is administered orally, following the prescribed dosage and schedule.
Step 4
Ongoing monitoring
Regular visits are scheduled to monitor health status and response to the treatment.
Blood tests and imaging studies are conducted periodically to assess the effectiveness of the medication.
Step 5
Evaluation of response
The overall response to the treatment is evaluated using specific criteria known as RECIST V1.1.
The primary focus is on the overall response rate, while secondary evaluations include duration of response and survival rates.
Step 6
Completion of study
The study is expected to conclude by February 26, 2027.
Final assessments are conducted to gather comprehensive data on the treatment's safety and effectiveness.

Who can join the trial?

14 criteria

Must be a male or female aged 18 years or older.
Must have a normal QT interval on an ECG test, which checks the heart's electrical activity. For men, it should be 450 milliseconds or less, and for women, 470 milliseconds or less.
Must have adequate blood and organ function.
Must be informed about the study and sign a written consent form before any study-related activities.
Must be willing and able to attend scheduled visits and follow study procedures.
If a female can have children, she must have a negative pregnancy test before joining the study.
Must have an ECOG performance status of 0-2, which is a scale that measures daily living abilities.
Must have confirmed Stage IIIB or IV non-small cell lung cancer (NSCLC) through tissue or cell examination.
Must have a documented change in the ALK gene locally.
Must not have had any previous treatment for Stage IIIB or IV non-squamous NSCLC.
Must have a life expectancy of at least 3 months.
If previously treated with chemotherapy, radiotherapy, or both for non-spreading disease, there must be a gap of at least 6 months since the last treatment before joining the study.
Can have untreated or treated brain metastases, as long as they are not causing symptoms and are stable.
Must have at least one measurable tumor, as defined by specific criteria (RECIST v1.1).

Who cannot join the trial?

3 criteria

Patients with medical conditions other than ALK+ non-small cell lung cancer cannot participate. This type of cancer is a specific form of lung cancer that has a particular genetic change known as ALK positive.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible for this study.

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Verified sites

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

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Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas De Gran Canaria, Spain
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Hospital De La Santa Creu I Sant Pau
Barcelona, Spain
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Hospital General Universitario De Valencia
Valencia, Spain

Trial locations

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Investigated drugs

Brigatinib is a medication used in this clinical trial to treat patients with non-small cell lung cancer that has a specific genetic change known as EML4-ALK translocation. The trial aims to evaluate how well patients respond to this treatment by using a method called RECIST V1.1 criteria, which helps in measuring the size and progression of tumors.

Brigatinib

What is already known about the treatment

Brigatinib – Brigatinib is administered orally in tablet form and is currently being studied for its effectiveness in treating ALK-positive non-small cell lung cancer. It is recognized in medical literature as a targeted therapy for this specific type of cancer. The main therapeutic indication for brigatinib is to treat patients with non-small cell lung cancer that have a specific genetic alteration known as EML4-ALK translocation. At the molecular level, brigatinib works by inhibiting the activity of the ALK protein, which is involved in the growth and spread of cancer cells. It is classified pharmacologically as a tyrosine kinase inhibitor, which helps to block the signals that promote cancer cell growth.

Investigated diseases

ALK-positive non-small cell lung cancer – This is a type of lung cancer characterized by changes in the anaplastic lymphoma kinase (ALK) gene. It is a subtype of non-small cell lung cancer, which is the most common type of lung cancer. The disease often begins in the cells lining the air passages and can spread to other parts of the body. ALK-positive non-small cell lung cancer tends to occur in younger individuals and those who have never smoked. The progression of the disease can vary, with some patients experiencing rapid growth of cancer cells, while others may have a slower progression. Symptoms may include persistent cough, chest pain, and difficulty breathing.