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Study Comparing Standard and Adjusted Doses of Alectinib for Patients with ALK Positive 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 ALK positive non-small cell lung cancer. The treatment being tested is a medication called Alecensa, which comes in the form of 150 mg hard capsules. The purpose of the study is to compare the effects of taking a standard dose of Alecensa with doses that are adjusted based on the levels of the drug in the blood. This approach is known as Therapeutic Drug Monitoring (TDM), which helps to tailor the medication dose to each patient's needs.

Participants in the study will be divided into two groups. One group will receive a standard fixed dose of Alecensa, while the other group will have their doses adjusted according to their blood levels of the drug. The study aims to see if adjusting the dose can help patients live longer without their cancer getting worse. This is referred to as progression-free survival, which means the time during which the cancer does not grow or spread.

Throughout the study, researchers will also look at other important factors, such as the safety of adjusting doses, how well patients respond to the treatment, and the overall quality of life for participants. The study will also measure how well doctors follow the dose recommendations and how patients adhere to their medication schedule. By the end of the study, researchers hope to gather valuable information that could improve treatment strategies for people with ALK positive non-small cell lung cancer.

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

    Enrollment

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, cancer stage, and previous treatments.

    A signed informed consent form is required before any study-related procedures begin.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current health status and disease progression.

    This includes imaging tests and laboratory evaluations to establish a baseline for future comparisons.

  3. Step 3

    Treatment allocation

    Participants are randomly assigned to one of two groups: the standard dosing group or the therapeutic drug monitoring (TDM) guided dosing group.

    The standard dosing group receives a fixed dose of Alecensa (alectinib) 150 mg capsules taken orally twice daily.

  4. Step 4

    Treatment phase

    In the TDM-guided group, blood levels of alectinib are monitored to adjust the dose as needed to maintain effective drug levels.

    Regular follow-up visits are scheduled to monitor health status, manage any side effects, and adjust treatment as necessary.

  5. Step 5

    Monitoring and evaluation

    Progression-free survival (PFS) is assessed using imaging and clinical evaluations to determine the effectiveness of the treatment.

    Additional assessments include overall response rates, quality of life, and any side effects experienced.

  6. Step 6

    Completion of study

    The study is expected to conclude by December 31, 2025.

    Final evaluations are conducted to assess the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

12 criteria

  • Patients must have a type of lung cancer called ALK positive non-small cell lung cancer.
  • The cancer should be in an advanced stage, either locally advanced or spread to other parts of the body (stage IIIB to stage IV).
  • Patients can participate in other observational studies while in this study.
  • Local radiotherapy is allowed if it is used for pain relief.
  • Participants must be male or female and at least 18 years old.
  • Patients should have an ECOG Performance Status of 0-4, which is a scale that measures how well a patient can perform daily activities.
  • The lung cancer diagnosis must be confirmed through a test called histology or cytology, which examines cells or tissues under a microscope.
  • There must be a documented change in the ALK gene using a test approved by the European Medicines Agency (EMA).
  • Patients can either have not received chemotherapy or have had one round of chemotherapy that includes a drug called platinum.
  • Patients with cancer that has spread to the brain or the lining of the brain are allowed if these areas are not causing symptoms, have no neurological signs, and have been stable for at least 2 weeks without the use of steroids.
  • The disease must be measurable using a specific set of guidelines called RECIST criteria version 1.1 before starting the study treatment.
  • Participants must sign a written consent form approved by an Institutional Review Board (IRB) or Ethical Committee (EC) before any study-related procedures are done.

Who cannot join the trial?

3 criteria

  • Patients who do not have ALK positive non-small cell lung cancer cannot participate. This is a specific type of lung cancer.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups that may need special protection, like children or the elderly.
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Investigated drugs

Alectinib is a medication used in this clinical trial to treat patients. It is typically used to manage certain types of lung cancer by targeting specific proteins in cancer cells, which helps to slow down or stop their growth. In this trial, alectinib is being tested in two different dosing strategies: a standard fixed dose and a dose adjusted based on therapeutic drug monitoring (TDM). The goal is to determine if adjusting the dose based on drug levels in the blood can improve treatment outcomes compared to the standard dosing approach.

What is already known about the treatment

Alectinib – Alectinib is administered orally in the form of capsules. It is currently used in the treatment of ALK-positive non-small cell lung cancer, with ongoing research to optimize its dosing through therapeutic drug monitoring. 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 of cancer cells. It is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

ALK positive non-small cell lung cancer – This is a type of lung cancer characterized by the presence of a specific genetic alteration known as anaplastic lymphoma kinase (ALK) rearrangement. It primarily affects non-small cell lung cancer (NSCLC) patients, which is the most common type of lung cancer. The disease progresses as cancer cells grow and spread in the lungs and potentially to other parts of the body. Patients with this condition may experience symptoms such as persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary, with some patients experiencing a slow progression while others may have a more rapid advancement. The presence of the ALK gene rearrangement can influence the behavior of the cancer and its response to certain treatments.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506886-76-00Protocol codeNL77596.042.21Estimated enrolment196 patientsSponsorUniversitair Medisch Centrum Groningen

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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).