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Study comparing brigatinib alone versus brigatinib with carboplatin and pemetrexed combination as first treatment for patients with advanced ALK-positive lung cancer

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What is this trial about?

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

This study focuses on patients with advanced ALK-positive non-small cell lung cancer, a specific type of lung cancer that has a particular genetic change. The research examines two treatment approaches: a combination therapy using multiple medications and a single medication treatment. The medications being studied include brigatinib (taken as tablets by mouth), carboplatin (given through a vein), and pemetrexed (given through a vein).

The main purpose of this research is to evaluate how well the combination of these medications works in treating this type of lung cancer. The study will track how patients respond to treatment over time, including how the cancer responds and what side effects may occur. Some patients will receive brigatinib alone, while others will receive brigatinib together with carboplatin and pemetrexed.

During the study, patients will receive regular medical check-ups and undergo various tests to monitor their health and how well the treatment is working. The treatment period may last up to 60 months, with regular assessments of the cancer's response to treatment. The medications will be given in specific doses, with brigatinib taken daily as tablets, while carboplatin and pemetrexed will be given through an intravenous line at scheduled intervals.

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

    Initial Treatment Assignment

    After joining the study, you will be assigned to receive either a combination therapy or a single medication treatment

    Your treatment will be determined randomly, similar to a coin flip

  2. Step 2

    Medication Schedule - Combination Therapy Group

    If assigned to the combination therapy, you will receive:

    Brigatinib tablets taken by mouth daily

    Carboplatin given through an IV (intravenous) infusion

    Pemetrexed given through an IV infusion

  3. Step 3

    Medication Schedule - Single Therapy Group

    If assigned to the single therapy, you will receive:

    Brigatinib tablets (30 mg or 180 mg) taken by mouth daily

  4. Step 4

    Regular Health Assessments

    Your health will be monitored through regular medical examinations

    Imaging scans will be performed to check how your cancer responds to treatment

    Blood tests will be conducted to monitor your body's response to the medications

  5. Step 5

    Quality of Life Evaluation

    You will complete questionnaires about how you are feeling and your daily activities

    These assessments help track your overall well-being during treatment

  6. Step 6

    Treatment Duration

    The study will continue until October 2028

    Your individual participation length will depend on how your condition responds to treatment

    Regular evaluations will determine if you should continue with the treatment

Who can join the trial?

17 criteria

  • Must sign an informed consent form before any study procedures begin
  • Must be at least 18 years old
  • Must have advanced ALK-positive non-small cell lung cancer that has spread or cannot be treated locally
  • Must have at least one measurable tumor that can be tracked during the study
  • Must be in relatively good physical condition (ECOG score of 0 or 1, meaning able to carry out light daily activities)
  • Must have adequate bone marrow function, including: - Normal white blood cell counts - Normal platelet levels - Adequate hemoglobin levels
  • Must have normal pancreas, liver, and kidney function tests
  • Must have normal heart rhythm on ECG test
  • Must have recovered from any previous cancer treatments, with minimal side effects
  • Must have recovered from any major surgery for at least 35 days before starting treatment
  • Must provide sufficient tumor tissue sample for analysis
  • Must have national health insurance coverage
  • For women who can become pregnant: must use two effective forms of birth control during the study and for 6 months after
  • For men: must use effective barrier contraception during the study and for 6 months after
  • Must be willing to attend all scheduled study visits and complete required tests
  • Patients with stable brain metastases may participate if their condition is controlled with low-dose steroids
  • Must have a life expectancy of at least 12 weeks

Who cannot join the trial?

14 criteria

  • History of severe allergic reactions to brigatinib, carboplatin, or pemetrexed (medications used in the study)
  • Pregnant or breastfeeding women
  • Active brain metastases (cancer that has spread to the brain) that are not treated or stable
  • Significant heart problems, including uncontrolled high blood pressure or recent heart attack (within 6 months)
  • Severe liver problems or abnormal liver function tests
  • Severe kidney problems or requiring dialysis
  • Current participation in other clinical trials
  • Major surgery within 4 weeks before starting the study
  • Active infections requiring treatment
  • Other types of cancer within the last 3 years (except for adequately treated skin cancer or cervical cancer)
  • History of interstitial lung disease (a condition affecting lung tissue)
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
  • Unable to swallow oral medications
  • Known resistance or allergy to ALK inhibitors (type of cancer medication)
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Investigated drugs

  • Brigatinib

    is a targeted therapy medication used to treat non-small cell lung cancer that has a specific genetic change (ALK-positive). It works by blocking the activity of the altered ALK protein that helps cancer cells grow and spread.

  • Carboplatin

    is a chemotherapy medication that belongs to the platinum-based drugs family. It works by interfering with cancer cell DNA, preventing cancer cells from dividing and growing.

  • Pemetrexed

    is a chemotherapy medication that blocks substances needed by cancer cells to grow and multiply. It specifically targets several enzymes that cancer cells need for survival, making it effective in treating non-small cell lung cancer.

What is already known about the treatment

  • Brigatinib

    An oral targeted therapy medication used primarily for treating advanced ALK-positive non-small cell lung cancer. This kinase inhibitor works by blocking specific proteins (ALK) that promote cancer cell growth, effectively slowing down or stopping the progression of cancer cells. Brigatinib belongs to the class of tyrosine kinase inhibitors and is administered in tablet form taken once daily, making it convenient for patients to use at home.

  • Carboplatin

    A platinum-based chemotherapy drug administered intravenously in a hospital setting to treat various types of cancer, including lung cancer. It works by binding to cancer cell DNA, interfering with cell division and causing cancer cell death. Carboplatin belongs to the platinum compounds class of chemotherapy drugs and is often chosen over similar drugs due to its more manageable side effect profile.

  • Pemetrexed

    An intravenous chemotherapy medication used in the treatment of non-small cell lung cancer and other malignancies. It functions as an antifolate, preventing cancer cells from using folic acid to create new DNA and RNA, thereby stopping cancer cell growth and division. Pemetrexed belongs to the antimetabolite class of chemotherapy drugs and is typically administered in cycles through an intravenous infusion in a clinical setting.

Investigated diseases

ALK-positive non-small cell lung cancer - A specific type of lung cancer that occurs when abnormal cells in the lungs' tissue develop a defect in the ALK (anaplastic lymphoma kinase) gene. This genetic change causes the cells to grow and spread in an uncontrolled way throughout the lungs. The disease typically begins in the outer regions of the lungs and can spread to nearby lymph nodes and other organs. ALK-positive NSCLC is more common in younger people and non-smokers. The condition affects the cells that line the air passages in the lungs, causing them to form tumors.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510387-13-00Protocol codeIFCT-2101Estimated enrolment110 patientsSponsorIntergroupe Francophone De Cancerologie Thoracique

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).