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Study on the Effectiveness and Safety of Carboplatin, Pemetrexed, and Lorlatinib for ALK Positive Non-Small Cell Lung Cancer with Extracranial Progression

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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 (NSCLC). This specific type of cancer is characterized by changes in the ALK gene, which can lead to cancer growth. The study is investigating the effectiveness and safety of a treatment combination that includes Platinum-Pemetrexed based chemotherapy and a medication called Lorlatinib. Lorlatinib is a drug that targets specific proteins involved in cancer cell growth and is also known by its code name, PF-06463922.

The purpose of the study is to evaluate how well this combination works in patients whose cancer has progressed outside the brain while on Lorlatinib. The study will involve taking Lorlatinib in the form of film-coated tablets, and the chemotherapy drugs, which include Carboplatin, Cisplatin, and Pemetrexed, will be administered as solutions for infusion, meaning they are given directly into the bloodstream through a vein. The study will follow participants over a period to monitor the progression of the disease and any side effects experienced.

Participants will receive the treatment and be monitored regularly to assess the impact on their cancer and overall health. The study aims to provide insights into whether this combination of treatments can help manage the disease more effectively compared to previous data. The trial will also collect information on the quality of life of participants and any adverse effects they may experience during the treatment period.

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
Joining the study
Upon joining the study, the patient will begin the treatment protocol designed for ALK positive Non-Small Cell Lung Cancer (NSCLC) with extracranial progression.
The study involves a combination of chemotherapy and a targeted therapy drug called lorlatinib.
Step 2
Treatment initiation
The treatment includes carboplatin and pemetrexed, both administered as an intravenous infusion. Carboplatin is given at a concentration of 10 mg/ml, and pemetrexed at 25 mg/ml.
Additionally, cisplatin may be used as an alternative to carboplatin, also administered intravenously at a concentration of 1 mg/ml.
Step 3
Oral medication
The patient will take lorlatinib orally in the form of film-coated tablets. The dosage is either 100 mg or 25 mg, depending on the specific treatment plan.
The frequency and duration of lorlatinib administration will be determined by the healthcare provider based on the patient's response to treatment.
Step 4
Monitoring and follow-up
Throughout the study, the patient's health and response to treatment will be closely monitored. This includes regular imaging tests such as CT and MRI scans to assess disease progression.
The study aims to evaluate the time until disease progression or any adverse effects, as well as the overall survival rate.
Step 5
Completion of study
The study is expected to continue until April 2028, with regular assessments to determine the effectiveness and safety of the treatment combination.
Upon completion, the data collected will contribute to understanding the treatment's impact on ALK positive NSCLC.

Who can join the trial?

11 criteria

You must provide written informed consent before starting any specific procedures related to the study. This means you agree to participate and understand what the study involves.
You should have an estimated life expectancy of at least 3 months, regardless of your diagnosis.
If you are a woman who can have children or a man with a partner who can have children, you must agree to avoid pregnancy by using effective birth control methods or abstaining from sex during the study and for at least 14 weeks after the last dose of study drugs.
You must be at least 18 years old when you sign the informed consent.
Your physical condition should be good, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. This means you are fully active or have some symptoms but can still carry out light work.
You must have a confirmed diagnosis of stage IV **ALK positive Non-Small Cell Lung Cancer (NSCLC)**. ALK positivity can be determined by specific tests like FISH, IHC, or NGS.
You should have measurable disease according to RECIST 1.1, which is a standard way to measure how well a cancer treatment works, using CT and MRI scans.
Your cancer must be progressing outside the brain while on Lorlatinib treatment. Lorlatinib can be your first or later treatment, and there are no limits on previous treatments. If you have had platinum-based treatment before, your eligibility for PT-pem chemotherapy will be decided by the study doctor.
You must have confirmed multiple progressions outside the brain on Lorlatinib, without new progressions in the central nervous system (CNS). This means no new brain metastasis or stable brain metastasis on Lorlatinib or after specific brain radiation treatments. Any previous brain radiation must have been completed at least 4 weeks before joining the study.
Your organs, like kidneys, bone marrow, and liver, must be functioning well. This includes specific blood counts and liver and kidney function tests within normal ranges.
If possible, a fresh tissue biopsy showing ALK translocation should be available, taken within 3 months before joining the study, and assessed by a local lab.

Who cannot join the trial?

5 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 for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who have not been treated with **Lorlatinib** before cannot participate. Lorlatinib is a medication used to treat certain types of cancer.
Patients who are not eligible for **PT/pem-based chemotherapy** cannot participate. This is a type of cancer treatment that uses specific drugs.

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Verified sites

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

Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Azienda Ospedaliero Universitaria Parma
Responsive
Parma, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy

Trial locations

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Investigated drugs

Platinum-based Chemotherapy
is a type of cancer treatment that uses drugs containing the metal platinum. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing. This therapy is often used to treat various types of cancer, including lung cancer.
Pemetrexed
is a chemotherapy drug that interferes with the growth of cancer cells. It is used in combination with other medications to treat non-small cell lung cancer. Pemetrexed works by blocking the enzymes needed for cancer cell replication.
Lorlatinib
is a targeted therapy used to treat non-small cell lung cancer that is positive for a specific genetic mutation known as ALK. It works by blocking the activity of the ALK protein, which helps stop the growth and spread of cancer cells.

What is already known about the treatment

Lorlatinib – Lorlatinib is administered orally in tablet form and is currently being studied in clinical trials for its effectiveness in treating ALK-positive Non-Small Cell Lung Cancer (NSCLC). It is approved for use in patients with this type of cancer, particularly when the disease has progressed outside the brain. Lorlatinib works by inhibiting the activity of an enzyme called anaplastic lymphoma kinase (ALK), which is involved in the growth and spread of cancer cells. It belongs to a class of medications known as ALK inhibitors, which are targeted therapies designed to block specific proteins that contribute to cancer development.

Investigated diseases

ALK positive Non-Small Cell Lung Cancer – This is a type of lung cancer characterized by the presence of an abnormal version of the anaplastic lymphoma kinase (ALK) gene. It is a subset of non-small cell lung cancer (NSCLC), 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. Patients with this condition often experience symptoms such as persistent cough, chest pain, and shortness of breath. The progression of the disease can vary, with some patients experiencing a slow progression while others may have a more rapid course. The presence of the ALK gene mutation can influence the behavior of the cancer and its response to certain treatments.