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Study on Brigatinib and Durvalumab for Patients with Unresectable Stage III Non-Small Cell Lung Cancer with ALK Gene Change After Chemotherapy and Radiation Therapy

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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 non-small cell lung cancer (NSCLC), specifically in patients who have a change in the ALK-gene. The study is testing the effects of a medication called brigatinib, also known by its code name AP26113, after patients have completed standard chemotherapy and radiation therapy. Another medication involved in the study is durvalumab, which is given as a solution for infusion. The purpose of the study is to evaluate how well brigatinib works in preventing the cancer from getting worse compared to just observation or treatment with durvalumab.

Participants in the study will be randomly assigned to one of the treatment groups. Some will receive brigatinib, which is taken orally as a film-coated tablet, while others may receive durvalumab or be under observation. The study will monitor the participants over a period to see how the cancer responds to these treatments. The main focus is on how long the cancer stays under control without progressing, which is known as progression-free survival. Other aspects like overall survival, which is the length of time patients live after starting the study, and the safety of the treatments will also be observed.

This trial is designed for patients with unresectable stage III NSCLC, meaning the cancer cannot be removed by surgery. It is important for participants to have completed their initial chemo-radiotherapy without the disease progressing. The study aims to provide valuable information on the effectiveness of brigatinib as a consolidation therapy, which is a treatment given after the initial therapy to strengthen its effect, in comparison to other options like durvalumab or observation.

The research process

The trial runs in 7 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, eligibility is confirmed based on specific criteria, including a diagnosis of non-small cell lung cancer (NSCLC) with a change in the ALK-gene.

    The patient must have completed chemotherapy and radiation therapy without disease progression.

  2. Step 2

    Randomization

    Randomization occurs within 8 weeks after the last radiation therapy session.

    The patient is assigned to one of the study groups: observation, brigatinib treatment, or durvalumab treatment.

  3. Step 3

    Brigatinib treatment

    If assigned to the brigatinib group, the patient receives brigatinib in the form of film-coated tablets.

    The medication is taken orally, with the dosage and frequency determined by the study protocol.

  4. Step 4

    Durvalumab treatment

    If assigned to the durvalumab group, the patient receives durvalumab as a concentrate for solution for infusion.

    The infusion is administered at intervals specified by the study protocol.

  5. Step 5

    Observation

    If assigned to the observation group, the patient does not receive additional medication but is monitored regularly for disease progression.

  6. Step 6

    Follow-up and monitoring

    Throughout the study, the patient's health is monitored to assess progression-free survival and other outcomes.

    Regular check-ups and tests are conducted to evaluate overall survival, CNS-relapse-free survival, and patterns of disease progression.

  7. Step 7

    Completion of the study

    The study is estimated to end by April 2029.

    Upon completion, the patient's participation in the study concludes, and final assessments are conducted.

Who can join the trial?

18 criteria

  • The patient must have a type of lung cancer called non-small cell lung cancer (NSCLC) that cannot be removed by surgery and is at stage III.
  • The cancer must have a specific change called ALK-fusion, which is confirmed by tests on the tumor.
  • The patient should not have received any treatment for this cancer before.
  • The patient must be able to perform daily activities with little or no help, as measured by a scale called ECOG Performance Status of 0 or 1.
  • The patient must be 18 years old or older.
  • The patient should be suitable for receiving a combination of chemotherapy and radiotherapy, as determined by the doctor.
  • Women who can have children must have a negative pregnancy test.
  • The patient must be able to follow the study rules, according to the doctor's judgment.
  • The patient must sign a document agreeing to participate in the study.
  • After completing radiotherapy, the patient must be ready for the next step of the study within 8 weeks.
  • The patient must have completed radiotherapy to the chest area.
  • The cancer should not have worsened after the initial treatment.
  • The patient must have normal blood, kidney, and liver function.
  • The patient should not have a lung condition called radiation pneumonitis that is severe.
  • Any side effects from previous treatment should be mild, except for hair loss.
  • The patient should be able to perform daily activities with little or no help, as measured by a scale called ECOG Performance Status of 0 to 2.
  • The patient should not have had major surgery within 4 weeks before starting the study treatment. Minor procedures are allowed.
  • The patient should not be taking certain strong medications that affect the liver within 14 days before starting the study treatment.

Who cannot join the trial?

7 criteria

  • Patients who have not completed their chemo-radiotherapy treatment.
  • Patients whose cancer has progressed after completing chemo-radiotherapy.
  • Patients who do not have a specific type of lung cancer called ALK-rearranged non-small cell lung cancer (NSCLC). This means their cancer cells have a change in a gene called ALK.
  • Patients with other serious health conditions that might interfere with the study.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.
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Investigated drugs

  • Brigatinib

    is a medication used in this trial as a consolidation therapy. It is being tested to see if it can help prevent the progression of non-small cell lung cancer (NSCLC) in patients who have a specific genetic change known as ALK-rearrangement. This medication is given to patients who have already completed chemotherapy and radiation therapy to see if it can help keep the cancer from coming back or spreading.

  • Durvalumab

    is another medication being studied in this trial. It is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. In this trial, it is being compared to observation to see if it can improve outcomes for patients with unresectable stage III NSCLC who have completed chemo-radiotherapy.

What is already known about the treatment

Brigatinib – Brigatinib is administered orally in tablet form and is currently being studied in clinical trials for its effectiveness in treating non-small cell lung cancer (NSCLC) with ALK-rearrangement. It is classified as a tyrosine kinase inhibitor and works by blocking specific proteins that promote cancer cell growth. This medication is primarily indicated for patients with unresectable stage III NSCLC who have completed chemo-radiotherapy. Its mechanism of action involves inhibiting the activity of the ALK protein, which is often overactive in certain types of cancer cells, thereby slowing or stopping their growth.

Investigated diseases

Non-small cell lung cancer – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. It often grows and spreads more slowly than small cell lung cancer. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502467-38-00Protocol codeETOP 21-21 BOUNCEEstimated enrolment55 patientsSponsorETOP IBCSG Partners Foundation

sourced from the EU Clinical Trials Register and site verification

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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).