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Study on Lorlatinib for Patients with Advanced ROS1-positive Non-Small Cell Lung Cancer After First-line Treatment Failure

Verified siteRegistered drugNo placebo
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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 advanced ROS1-positive non-small cell lung cancer (NSCLC). The treatment being tested is a medication called Lorlatinib, which is also known by its code name PF-06463922. This medication is taken in the form of film-coated tablets. The purpose of the study is to evaluate how effective Lorlatinib is for patients whose cancer has progressed after initial treatment with other medications called tyrosine kinase inhibitors, specifically crizotinib or entrectinib.

Participants in the study will take Lorlatinib orally, which means by mouth, for a period of up to 72 weeks. The study will monitor the participants' response to the treatment, including any changes in their cancer and overall health. The study aims to see if Lorlatinib can help control the cancer and improve the patients' quality of life. Throughout the study, participants will have regular check-ups and tests to track their progress and any side effects they might experience.

The study will also look at how long participants live without their cancer getting worse, known as progression-free survival, and overall survival, which is the time from starting the treatment until death from any cause. Additionally, the study will assess the impact of Lorlatinib on brain metastases, which are cancer cells that have spread to the brain. Participants will be closely monitored to ensure their safety and to gather information on how well the treatment works in different molecular subgroups of patients with this type of lung cancer.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, the patient will begin by taking lorlatinib, a medication used to treat advanced ROS1-positive non-small cell lung cancer. This medication is administered orally in the form of film-coated tablets.

    The patient will receive either Lorviqua 100 mg or Lorviqua 25 mg tablets, depending on the prescribed dosage.

  2. Step 2

    Treatment administration

    The patient will take the prescribed dosage of lorlatinib daily. The exact dosage and frequency will be determined by the healthcare provider based on individual needs and response to the treatment.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient's response to the treatment will be closely monitored. This includes regular visits to the healthcare provider for assessments and laboratory tests.

    The primary goal is to evaluate the effectiveness of lorlatinib in treating the cancer, with assessments occurring at 8 weeks and confirmation at 16 weeks.

  4. Step 4

    Progress evaluation

    The patient's progress will be evaluated using criteria such as the objective response rate, progression-free survival, and overall survival. These evaluations help determine the treatment's impact on the cancer.

  5. Step 5

    Completion of the study

    The study is expected to continue until January 15, 2027. The patient's participation will involve ongoing assessments and treatment until the study's conclusion or until the healthcare provider determines it is appropriate to stop.

Who can join the trial?

20 criteria

  • Must have signed a written informed consent form, showing understanding of the study and willingness to participate.
  • Must be able to attend scheduled visits, follow the treatment plan, and undergo necessary tests.
  • Must have a confirmed diagnosis of advanced **ROS1-positive non-small cell lung cancer** (NSCLC), which means the cancer has a specific genetic change called ROS1 rearrangement.
  • Must have adequate **bone marrow function**, which includes having enough white blood cells, platelets, and hemoglobin.
  • Must have adequate **pancreatic function**, meaning normal levels of a digestive enzyme called lipase.
  • Must have adequate **renal function**, which means normal levels of a waste product called creatinine or a certain level of kidney function.
  • Must have adequate **liver function**, meaning normal levels of bilirubin and liver enzymes (AST and ALT).
  • Must have recovered from any side effects of previous treatments to a mild level, except for those that are not considered a safety risk.
  • Must have recovered from any major surgery or significant injury at least 35 days before starting the study treatment.
  • Females of childbearing potential must have a negative pregnancy test and agree to use effective birth control methods during the study and for 90 days after the last dose.
  • Males must agree to use effective birth control methods during the study and for 14 weeks after the last dose, and not donate sperm during this time.
  • Must have national health insurance coverage.
  • If previously treated with a drug called ROS1-TKI, must wait 7 days after the last dose before starting the study treatment, unless the doctor decides otherwise.
  • Must have experienced disease progression after one prior treatment with crizotinib or entrectinib, and possibly chemotherapy.
  • Must have at least one measurable tumor according to specific guidelines.
  • Patients with stable brain metastases (cancer spread to the brain) may be eligible if they are not causing symptoms and are controlled with stable or decreasing steroid use.
  • Must provide a tumor sample for analysis, either from a biopsy or blood samples if the biopsy is not usable.
  • Must be at least 18 years old.
  • Must have a life expectancy of at least 12 weeks, as judged by the doctor.
  • Must have an **ECOG Performance Status** of 2 or less, which is a measure of the patient's ability to perform daily activities.

Who cannot join the trial?

6 criteria

  • Patients who do not have advanced ROS1-positive non-small cell lung cancer cannot participate. This means the cancer must be of a specific type and stage.
  • Patients who have not had a molecular analysis of their disease progression after first-line treatment with specific drugs (crizotinib or entrectinib) are excluded. This analysis checks for changes in the cancer at a molecular level.
  • Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
  • Patients who are not part of the specified clinical trial groups are excluded. This means the study is looking for participants with certain characteristics or conditions.
  • Both male and female patients are eligible, so exclusion is not based on gender.
  • Patients who are considered part of a vulnerable population may be excluded. This refers to groups who might be at higher risk or need special protection in research.
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Investigated drugs

  • Lorlatinib

    is a medication being studied for its effectiveness in treating patients with advanced non-small cell lung cancer that is positive for the ROS1 gene. It is used after the disease has progressed despite initial treatment with other medications. Lorlatinib works by targeting specific proteins in cancer cells, which may help to stop their growth and spread.

  • Crizotinib

    is a medication that was used as a first-line treatment for patients with advanced ROS1-positive non-small cell lung cancer. It works by blocking certain proteins that are involved in the growth of cancer cells. This medication is used before trying lorlatinib if the cancer progresses.

  • Entrectinib

    is another first-line treatment option for patients with advanced ROS1-positive non-small cell lung cancer. Like crizotinib, it targets specific proteins in cancer cells to help prevent their growth. It is used prior to lorlatinib if the initial treatment does not stop the cancer from progressing.

What is already known about the treatment

Lorlatinib – Lorlatinib is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating advanced ROS1-positive non-small cell lung cancer, particularly after the failure of first-line treatments like crizotinib or entrectinib. The main therapeutic indication for lorlatinib is advanced non-small cell lung cancer with specific genetic mutations. At the molecular level, lorlatinib works by inhibiting the activity of certain proteins involved in cancer cell growth, specifically targeting the ROS1 protein. It is classified pharmacologically as a tyrosine kinase inhibitor, which helps to block the signals that promote cancer cell proliferation.

Investigated diseases

Advanced ROS1-positive non-small cell lung cancer – This is a type of lung cancer characterized by the presence of a specific genetic alteration known as ROS1 rearrangement. It primarily affects the cells lining the lungs and is classified as non-small cell, which is the most common type of lung cancer. The disease tends to progress by spreading to other parts of the body, including the brain and bones. Patients with this condition often experience symptoms such as persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary, with some patients experiencing rapid advancement while others may have a slower course. The presence of ROS1 rearrangement can influence the behavior of the cancer and its response to certain treatments.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512028-12-00Protocol codeIFCT-2003Estimated enrolment84 patientsSponsorIntergroupe Francophone De Cancerologie Thoracique

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