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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 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 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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

8 criteria

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 trial?

7 criteria

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.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Unita Sanitaria Locale Della Romagna
Verified
Faenza, Italy
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy
Universita Degli Studi Di Roma La Sapienza
Responsive
Rome, Italy

Trial locations

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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.

What is already known about the treatment

Alectinib
Alectinib is administered orally in the form of capsules. It is currently recognized in medical literature as a treatment for ALK-positive non-small cell lung cancer (NSCLC). The main therapeutic indication for alectinib is to treat patients with this specific type of lung cancer. At the molecular level, alectinib works by inhibiting the activity of the anaplastic lymphoma kinase (ALK) enzyme, which is involved in the growth and spread of cancer cells. It is classified as a tyrosine kinase inhibitor.
Crizotinib
Crizotinib is taken orally in capsule form. It is well-documented in medical literature as a treatment option for ALK-positive non-small cell lung cancer (NSCLC). The primary therapeutic use of crizotinib is to manage this type of lung cancer. Its mechanism of action involves blocking the ALK enzyme, which helps to slow down or stop the growth of cancer cells. Crizotinib is also classified as a tyrosine kinase inhibitor.

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.