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 study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Netherlands Cancer Institute	Amsterdam	The Netherlands
Umzcxhwohsip Mjanwjr Cbwwbpt Gclzplwls	Groningen	The Netherlands
Ahccrmhuz Uuf	Amsterdam	The Netherlands
Szcapxwtu Rlvlkml Uxzhziinry Mhutrmu Ckbqvw	Nijmegen	The Netherlands
Egbtwia Uiaamjsgymha Mxidkjd Cptfazg Rppssslsd (utsujfu Mvf	Rotterdam	The Netherlands
Laweh Ugylcsbmlgys Mwidtke Cmwujsc (rilda	Leiden	The Netherlands

Trial status

Country	Status	Recruitment Start
France	Recruiting	23.03.2022
The Netherlands	Recruiting	23.03.2022

Trial locations

Investigated drugs:

Alectinib

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.

Investigated diseases:

Non-small cell lung cancer

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 ID:

2023-506886-76-00

Protocol code:

NL77596.042.21

NCT ID:

NCT05525338

Trial Phase:

Therapeutic confirmatory (Phase III)

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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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