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Study on Brigatinib, Ceritinib, and Alectinib for Patients with Advanced 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 anaplastic lymphoma kinase positive non-small cell lung cancer (ALK+ NSCLC). This is a specific form of lung cancer where the cancer cells have a change in the ALK gene, which can affect how the cancer grows. The study is testing a medication called brigatinib, which is taken as a film-coated tablet. Brigatinib is being compared to other similar medications, known as second-generation tyrosine kinase inhibitors (TKIs), which include ceritinib and alectinib. These medications are designed to target and block the activity of the ALK protein, which may help to slow down or stop the growth of cancer cells.

The purpose of this study is to compare how effective brigatinib is when used as the first treatment option for patients with ALK+ NSCLC, compared to other second-generation TKIs. Participants in the study will receive either brigatinib or another TKI, and their progress will be monitored over time. The study will look at how long the treatment can prevent the cancer from getting worse, as well as other factors like overall survival and the impact on the brain, which is a common area for cancer to spread in ALK+ NSCLC.

Participants will take the medication orally, and the study will last for a period of up to 68 weeks. Throughout the study, researchers will collect information to understand how well the treatments work and how they affect the participants' quality of life. The study will also explore different genetic changes in the cancer cells, such as TP53 mutations, to see if these affect how well the treatments work. This research aims to provide valuable insights into the best treatment options for patients with ALK+ NSCLC.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to provide fully informed written consent. This means you agree to participate after understanding all aspects of the study.

    A current biopsy will be collected during the screening phase to ensure eligibility for the study.

  2. Step 2

    Initial assessments

    You will undergo various assessments to confirm your eligibility, including a pregnancy test if applicable, and tests to ensure adequate organ function.

    Your medical history will be reviewed, and you will need to have a measurable lesion as per specific criteria.

  3. Step 3

    Treatment phase

    You will begin treatment with brigatinib, which is administered orally. The dosage and frequency will be determined by the study protocol.

    The treatment will continue as long as it is effective and you do not experience unacceptable side effects.

  4. Step 4

    Regular monitoring

    Throughout the study, you will have regular visits to monitor your health and the effectiveness of the treatment.

    These visits will include physical exams, imaging tests, and laboratory tests to assess your response to the treatment.

  5. Step 5

    End of treatment

    The treatment phase will conclude based on the study's criteria, which may include disease progression or completion of the study period.

    You will have a final assessment to evaluate your overall health and the outcomes of the treatment.

  6. Step 6

    Follow-up

    After the treatment phase, you will enter a follow-up period where your health will continue to be monitored.

    This may involve periodic visits and assessments to ensure your well-being and gather long-term data on the treatment's effects.

Who can join the trial?

12 criteria

  • Provide fully informed written consent and any required local authorization.
  • A current biopsy sample must be possible to collect during screening.
  • Women who can have children must have a negative pregnancy test within 7 days before starting the study and must not be breastfeeding.
  • Women who are postmenopausal for at least 1 year, surgically sterile, or agree to use highly effective non-hormonal birth control or abstain from heterosexual intercourse during the study and for 4 months after the last dose. Men must agree to use effective barrier contraception or abstain from heterosexual intercourse during the study and for 3 months after the last dose.
  • Must be male or female and at least 18 years old.
  • Must have a confirmed diagnosis of locally advanced (stage III) or metastatic (stage IV) ALK+ NSCLC (a type of lung cancer). Documentation of ALK rearrangement (a specific genetic change) must be available.
  • No previous treatment for metastatic ALK+ NSCLC, except for 1 or 2 cycles of chemotherapy, chemo-immunotherapy, immunotherapy, or brain radiation before joining the study.
  • Must have at least one measurable lesion (an area of cancer that can be measured) according to specific criteria.
  • Must have an ECOG performance status of 0, 1, or 2, which means being fully active or having some limitations but able to care for oneself.
  • Must have adequate organ function, including specific levels for bilirubin, kidney function, liver enzymes, lipase or amylase, platelet count, hemoglobin, and neutrophil count.
  • Must be willing and able to attend scheduled visits and follow study procedures.
  • Must be willing to participate in additional research related to the study.

Who cannot join the trial?

5 criteria

  • Patients with a different type of cancer than ALK+ NSCLC cannot participate. ALK+ NSCLC is a specific type of lung cancer.
  • Patients who have already received treatment that aims to cure their cancer cannot participate.
  • Patients who have cancer that has spread to other parts of the body and are not suitable for treatment that aims to cure cannot participate.
  • Patients who have received a specific type of cancer treatment called a 2nd-generation TKI cannot participate. A TKI is a type of medication that blocks cancer cell growth.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
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Investigated drugs

Brigatinib is a medication used in this clinical trial to treat patients with a specific type of lung cancer known as ALK-positive non-small cell lung cancer (ALK+ NSCLC). This medication works by blocking the activity of a protein that helps cancer cells grow and spread. By inhibiting this protein, brigatinib can help slow down or stop the growth of cancer cells, potentially improving the patient's condition.

What is already known about the treatment

Brigatinib – Brigatinib is a medication administered orally in the form of tablets. It is currently being studied for its effectiveness in treating patients with a specific type of lung cancer known as ALK-positive non-small cell lung cancer (ALK+ NSCLC), particularly in cases where the cancer is advanced or has spread to other parts of the body. The main therapeutic use of Brigatinib is to target and inhibit the activity of a protein called ALK, which is involved in the growth and spread of cancer cells. By blocking this protein, Brigatinib helps to slow down or stop the progression of the cancer. It belongs to a class of drugs known as tyrosine kinase inhibitors, which work by interfering with specific enzymes that promote cancer cell growth.

Investigated diseases

Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer (ALK+ NSCLC) – This is a type of lung cancer characterized by the presence of a specific genetic alteration involving the anaplastic lymphoma kinase (ALK) gene. It typically begins in the tissues of the lungs and can spread to other parts of the body. The disease progresses as cancer cells grow uncontrollably, forming tumors that can invade nearby tissues. In advanced stages, it may spread to distant organs, a process known as metastasis. The progression of ALK+ NSCLC can vary, with some patients experiencing rapid growth and others having a slower course. The presence of ALK gene rearrangements is a key factor in the development and progression of this cancer type.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513947-94-00Protocol codeABP-2019Estimated enrolment118 patientsSponsorFrankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).