Study on Lorlatinib for Patients with ALK-Positive or ROS1-Positive Non-Small Cell Lung Cancer Continuing from Previous Studies

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as non-small cell lung cancer (NSCLC). The study involves a treatment called lorlatinib, which is also known by its code name PF-06463922. Lorlatinib is a medication taken in tablet form and works by targeting specific proteins in cancer cells, known as ALK and ROS1 kinases, which are involved in the growth of cancer cells.

The purpose of this study is to monitor the safety and how well patients can tolerate lorlatinib. Participants in this study are those who have already been receiving lorlatinib in previous studies and have shown benefits from the treatment. The study is designed to continue providing lorlatinib to these participants to further observe its effects over time.

During the study, participants will continue taking lorlatinib as they have been in previous studies. The study will keep track of any side effects or serious health issues that might occur. This information will help researchers understand more about the long-term use of lorlatinib in treating non-small cell lung cancer. Some participants may receive a placebo as part of the study. The study is expected to continue until the end of 2026.

1 joining the study

Upon joining the study, you will be required to provide signed informed consent. This means you agree to follow the study’s requirements and restrictions.

You must have adequate organ function, which will be assessed through specific blood tests to check liver, bone marrow, and kidney function.

2 treatment continuation

You will continue receiving the study medication, lorlatinib, which is taken orally. The dosage and frequency will be determined by the study team based on your previous treatment.

The main goal is to monitor the safety and tolerability of lorlatinib during the study.

3 regular visits

You will need to attend all scheduled visits as part of the study. These visits are important for monitoring your health and the effects of the medication.

During these visits, various tests and assessments will be conducted to ensure your safety and to evaluate the treatment’s effectiveness.

4 monitoring side effects

The study team will closely monitor any side effects you may experience. This includes any adverse events (AEs) that might lead to stopping the medication permanently.

Serious adverse events (SAEs) will also be tracked to ensure your safety throughout the study.

5 study duration

The study is expected to continue until December 31, 2026. Your participation will be required for the duration of the study unless otherwise advised by the study team.

Your continued participation is contingent upon deriving clinical benefit from the treatment, as determined by the study’s principal investigator.

Who Can Join the Study?

Participants must have lung cancer and be receiving treatment in a Pfizer-sponsored Lorlatinib Parent Study, showing clinical benefit as determined by the study doctor.
Participants must agree to follow specific guidelines related to reproduction, which are detailed in the study’s appendix.
Participants must have adequate organ function:
- Liver function: Blood tests for liver enzymes (AST and ALT) should be no more than 2.5 times the normal limit, or up to 5 times if liver issues are due to cancer. Total bilirubin should be no more than 1.5 times the normal limit, except for those with Gilbert’s syndrome.
- Bone marrow function: A type of white blood cell called neutrophils should be at least 1000 per microliter. Platelets, which help with blood clotting, should be at least 50,000 per microliter. Hemoglobin, which carries oxygen in the blood, should be at least 8.0 grams per deciliter.
- Kidney function: Serum creatinine, a waste product in the blood, should be no more than 2 times the normal limit.
Participants must be willing and able to attend all scheduled visits, follow the treatment plan, and participate in other study procedures.
Participants must be capable of giving signed informed consent, which means they understand and agree to the study’s requirements and restrictions.

Who Cannot Join the Study?

Patients with any other type of cancer besides lung cancer cannot participate.
Patients who have had a major surgery within the last 4 weeks are not eligible.
Patients who are currently participating in another clinical trial are excluded.
Patients with uncontrolled high blood pressure are not allowed to join.
Patients with severe heart disease, such as heart failure, cannot take part.
Patients with active infections, like untreated bacterial or viral infections, are excluded.
Patients who are pregnant or breastfeeding cannot participate.
Patients with known allergies to the study medication are not eligible.
Patients with a history of drug or alcohol abuse in the past year are excluded.
Patients with a mental health condition that affects their ability to understand the study cannot join.

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

Other Sites

Site Name	City	Country	Status
Huaihiyg Vfuu dykagkel	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	04.08.2022
Spain	Not recruiting	04.08.2022

Trial locations

Investigated drugs:

Lorlatinib

Lorlatinib is a medication used in this clinical trial. It is designed to help treat a type of lung cancer known as non-small cell lung cancer (NSCLC) that is positive for ALK or ROS1. This medication works by blocking certain proteins that help cancer cells grow and spread. By doing this, it aims to slow down or stop the progression of the cancer. Participants in this study are continuing their treatment with Lorlatinib from previous clinical studies, and the trial is focused on monitoring how safe and tolerable the medication is for them over time.

Investigated diseases:

Non-small cell lung cancer

Lung cancer – Lung cancer is a disease characterized by the uncontrolled growth of abnormal cells in one or both lungs. These abnormal cells do not develop into healthy lung tissue; instead, they divide rapidly and form tumors. As the disease progresses, these tumors can interfere with the lung’s primary function of providing oxygen to the bloodstream. The cancer cells can also spread to other parts of the body, a process known as metastasis. Lung cancer is often categorized into two main types: non-small cell lung cancer and small cell lung cancer, each with distinct growth patterns. The progression of lung cancer can vary significantly depending on the type and stage of the disease.

Trial ID:

2023-508952-21-00

Protocol code:

B7461039

NCT ID:

NCT05144997

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Lorlatinib for Patients with ALK-Positive or ROS1-Positive Non-Small Cell Lung Cancer Continuing from Previous Studies

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?