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Study Comparing Alectinib and Crizotinib for Patients with ALK-Positive Advanced 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 (ALK)-positive non-small cell lung cancer (NSCLC). This is a specific form of lung cancer where the cancer cells have a change in the ALK gene, which can promote cancer growth. The study is comparing two treatments: Alectinib (Alecensa) and Crizotinib. Both of these medications are taken orally in the form of hard capsules and are designed to target and inhibit the activity of the ALK protein, which is involved in the growth of cancer cells.

The purpose of the study is to evaluate and compare the effectiveness of Alectinib and Crizotinib in patients who have not received prior treatment for their advanced ALK-positive NSCLC. Participants in the study will be randomly assigned to receive either Alectinib or Crizotinib. The study will monitor how long the cancer is controlled without worsening, which is known as progression-free survival. Other aspects such as overall survival, quality of life, and any side effects will also be observed.

Throughout the study, participants will undergo regular check-ups and assessments to track their health and the cancer’s response to the treatment. The study aims to provide valuable information on which medication might be more effective for patients with this specific type of lung cancer. The trial is expected to continue until 2026, allowing researchers to gather comprehensive data on the long-term effects and benefits of these treatments.

1 initial assessment

A diagnosis of advanced or recurrent non-small cell lung cancer (NSCLC) that is positive for anaplastic lymphoma kinase (ALK) is confirmed through specific tests.

Tests include immunohistochemistry (IHC) and fluorescent in situ hybridization (FISH) performed on tumor tissue at designated laboratories.

Eligibility is determined based on measurable disease, no prior systemic treatment for advanced NSCLC, and adequate organ function.

2 randomization

Participants are randomly assigned to receive either alectinib or crizotinib.

This process ensures that each participant has an equal chance of receiving either treatment.

3 treatment administration

Participants receive the assigned medication orally in the form of hard capsules.

Alectinib is administered as per the study protocol, and crizotinib is administered as XALKORI 250 mg hard capsules.

The frequency and duration of administration are determined by the study protocol and monitored by the study team.

4 monitoring and evaluation

Progression-free survival (PFS) is assessed by investigators to evaluate the effectiveness of the treatment.

Secondary evaluations include time to progression in the central nervous system (CNS), overall response rate, duration of response, and overall survival.

Participants’ health-related quality of life and safety are monitored throughout the study.

5 completion of study

The study is estimated to conclude by September 29, 2026.

Final assessments are conducted to gather comprehensive data on the efficacy and safety of the treatments.

Who Can Join the Study?

  • The patient must have a confirmed diagnosis of advanced or returning non-small cell lung cancer (NSCLC) that is ALK-positive. This means the cancer has a specific change in the anaplastic lymphoma kinase (ALK) gene. The cancer must be at a stage where it has spread and cannot be treated with multiple types of treatments.
  • The patient must have a measurable disease. This means the cancer can be measured in size using specific criteria called Response Evaluation Criteria In Solid Tumors (RECIST).
  • The patient should not have received any previous treatments that affect the whole body for their advanced or returning NSCLC.
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 2 being able to do some activities but not work.
  • The patient must have normal blood, kidney, and liver function.
  • If the patient has cancer that has spread to the brain or the area around the brain, it must not be causing symptoms. If there are symptoms, the patient must have completed specific treatments for the brain at least 14 days before joining the study and must be stable.
  • The study is open to both male and female patients.
  • The study includes patients who are considered vulnerable, meaning they might need extra protection or care.

Who Cannot Join the Study?

  • Patients who have previously received treatment for their ALK-positive non-small cell lung cancer (NSCLC). This means if you have already been treated for this specific type of lung cancer, you cannot participate.
  • Patients with other serious medical conditions that might interfere with the study. This includes any health issues that could make it unsafe for you to participate or affect the study results.
  • Patients who are pregnant or breastfeeding. This is to ensure the safety of both the mother and the baby.
  • Patients who are unable to follow the study procedures. This means if you cannot comply with the study requirements, you may not be eligible.
  • Patients with a history of certain heart problems. This includes any past heart conditions that could pose a risk during the study.
  • Patients with active infections that require treatment. If you have an infection that needs medical attention, you may not be able to join the study.
  • Patients who have participated in another clinical trial recently. This is to avoid any interference with the results of this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital Santa Maria Della Misericordia Perugia Italy
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy Otwock Poland
Uzefzlxurrvobr Cyssnfc Keyomlwbm Gdansk Poland
Uwdakijweq Dapzb Sgjjy Db Rofg Lt Stxlqgrj Rome Italy

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

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
07.11.2014
Poland Poland
Not recruiting
07.11.2014
Portugal Portugal
Not recruiting
07.11.2014
Spain Spain
Not recruiting
07.11.2014

Trial locations

Investigated drugs:

Alectinib is a medication used in this trial to treat patients with advanced non-small cell lung cancer that is positive for anaplastic lymphoma kinase (ALK). It works by blocking the activity of the ALK protein, which can help slow or stop the growth of cancer cells.

Crizotinib is another medication used in the trial for the same type of lung cancer. Like alectinib, it targets the ALK protein, aiming to prevent cancer cells from growing and spreading. The trial compares the effectiveness of crizotinib with alectinib in patients who have not received previous treatment for their cancer.

Investigated diseases:

Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer characterized by the presence of a specific genetic mutation in the ALK gene. It is a subtype of non-small cell lung cancer, which is the most common type of lung cancer. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. ALK-positive NSCLC is known for its aggressive nature and tendency to progress rapidly. Patients with this condition often experience symptoms such as persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary, but it generally involves the growth and spread of cancerous cells within the lungs and potentially to other organs.

Trial ID:
2023-506859-13-00
Protocol code:
BO28984
Trial Phase:
Therapeutic confirmatory (Phase III)

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