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 study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centr Georges Francois Leclerc Dijon France
Centre Jean Perrin Clermont Ferrand France
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France
Centre Hospitalier Intercommunal Creteil Creteil France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
HIA Sainte Anne Toulon France
Hopital Ambroise Pare Boulogne-Billancourt France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier De Saint-Quentin Saint Quentin France
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace Mulhouse France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Les Hopitaux Nord-Ouest Villefranche sur Saône France
Cxeadn Lvnx Boiqzj Lyon France
Cpdoam Huqgwsscoaf Ee Uiadvvqzglrky De Lufpceu Limoges France
Ajzqcavudt Pcqprlrl Hztzhbyi Dr Mtleghwtq Marseille France
Bxirsbrw Udmbgbrtvj Hjkehuei Cidzhc Besançon France
Cfqkne Hycxajiwojo Rtekfgkr Dbavyomevzjclz Angers France
Ighsbayj Pvqfzymogtnfsxs Cuabjq Csrqjo Marseille France
Hnjzyvub Ujuysnsbvkmeyx Sujpxhanxo &apujxf Hcqfvfl dr Hpcnifmhqld STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
France France
Not recruiting
31.05.2022

Trial locations

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.

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 ID:
2023-510387-13-00
Protocol code:
IFCT-2101
NCT ID:
NCT05200481
Trial Phase:
Therapeutic exploratory (Phase II)

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