Study on Brigatinib, Ceritinib, and Alectinib for Patients with Advanced ALK+ Non-Small Cell Lung Cancer

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Universitätsklinikum Freiburg Freiburg Im Breisgau Germany

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Franziskus Hospital Harderberg Georgsmarienhütte Germany
Pius-Hospital Oldenburg Oldenburg In Holstein Germany
HELIOS Klinikum Emil von Behring GmbH Berlin Germany
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Evangelisches Krankenhaus Hamm gGmbH Hamm Germany
KRH Klinikum Siloah Hanover Germany
Universitaetsklinikum Regensburg AöR Regensburg Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Kliniken der Stadt Koeln gGmbH Cologne Germany
Justus-Liebig-Universitaet Giessen Giessen Germany
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH Hemer Germany
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universitaetsklinikum Leipzig AöR Leipzig Germany
Friedrich-Schiller-Universität Jena Jena Germany
Studiengesellschaft Haematologie-Onkologie Hamburg Hamburg Germany
Ufqfqepbxnwhxyohgpcdu Euvnq Ash Essen Germany
Mru Ir dhj Npibw Senfuag Kfdyvgom Georgsmarienhütte Germany
Kgdeys Sreybkthozjs Stuttgart Germany
Upqtxdntxjczqkeamviyy Miznbpbq Ayg Munster Germany
Kciylvkd dic Uxmhayztsckf Mqslmqbt Acu Munich Germany
Uvyohoecqmqannximniik Wiiehknwf Aaz Wuerzburg Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
16.12.2019

Trial locations

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.

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 ID:
2024-513947-94-00
Protocol code:
ABP-2019
NCT ID:
NCT04318938
Trial Phase:
Therapeutic exploratory (Phase II)

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