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Study Comparing Lorlatinib and Crizotinib for Patients with Advanced 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 specific type of lung cancer known as advanced ALK-positive non-small cell lung cancer. The study is comparing two treatments: lorlatinib, which is also known by its code name PF-06463922, and crizotinib. Both of these are medications taken in tablet form. The purpose of the study is to determine if lorlatinib is more effective than crizotinib in delaying the progression of this type of lung cancer.

Participants in the study will be randomly assigned to receive either lorlatinib or crizotinib as their treatment. The study will monitor the participants over a period to see how the cancer responds to the treatment. This will help researchers understand which medication might be better at controlling the disease. Some participants will receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatments.

The study aims to provide valuable information about the effectiveness and safety of these treatments for patients who have not received prior treatment for their advanced lung cancer. By participating, individuals contribute to research that could improve future treatment options for this type of cancer. The study is expected to continue until the end of 2028.

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

    Randomization

    Upon joining the study, participants are randomly assigned to one of two groups. One group receives lorlatinib and the other receives crizotinib. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment.

  2. Step 2

    Treatment administration

    Participants in the lorlatinib group take the medication orally. The specific dosage and frequency are determined by the study protocol and are communicated to participants by the study team.

    Participants in the crizotinib group also take their medication orally, with the dosage and frequency similarly specified by the study protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the study, participants undergo regular monitoring to assess the effectiveness and safety of the treatment. This includes physical examinations, blood tests, and imaging studies such as CT or MRI scans.

    Participants are also monitored for any side effects or adverse reactions to the medication. This information is collected to ensure participant safety and to evaluate the treatment's impact on the disease.

  4. Step 4

    Progression-free survival evaluation

    The primary goal of the study is to determine if lorlatinib is more effective than crizotinib in delaying the progression of the disease. This is measured by the time during which the disease does not worsen, known as progression-free survival (PFS).

    Evaluations are conducted by an independent review to ensure unbiased results.

  5. Step 5

    Study completion

    The study is expected to continue until December 31, 2028. Participants remain in the study until they complete the treatment protocol or until the study ends.

    Upon completion, participants may receive information about the overall study results and their individual treatment outcomes.

Who can join the trial?

16 criteria

  • Patients must have a confirmed diagnosis of advanced **ALK positive non-small cell lung cancer**. This means the cancer has a specific genetic change called ALK, and it is in an advanced stage.
  • Patients must have at least one measurable tumor outside the brain that has not been treated with radiation before.
  • Patients can have cancer that has spread to the brain if it is not causing symptoms or if it has been treated and they have recovered.
  • Patients must provide a tissue sample from their tumor for testing. If a previous sample is not available, a new biopsy must be done.
  • Female patients who can have children must have a negative pregnancy test before starting the study.
  • Female patients who cannot have children must meet certain criteria, such as being postmenopausal or having had surgery to remove reproductive organs.
  • Patients must sign a consent form to show they understand the study and agree to participate.
  • Patients must be willing and able to attend scheduled visits and follow the study procedures.
  • Patients must not have received any previous treatment for advanced lung cancer, including specific drugs targeting ALK, chemotherapy, or immunotherapy.
  • Patients must have a performance status of 0, 1, or 2, which means they are able to carry out daily activities with varying degrees of assistance.
  • Patients must be at least 18 years old (or 20 years old if required by local regulations).
  • Patients must have adequate bone marrow function, which includes having enough white blood cells, platelets, and hemoglobin.
  • Patients must have adequate pancreatic function, meaning certain enzyme levels in the blood must be within normal limits.
  • Patients must have adequate kidney function, which involves having normal levels of creatinine in the blood or a certain level of kidney filtration.
  • Patients must have adequate liver function, with specific liver enzyme levels within normal limits.
  • Any side effects from previous radiation therapy must have resolved to a mild level or to the level they were before treatment, unless the doctor believes they are not a safety risk.

Who cannot join the trial?

9 criteria

  • Patients who have previously received treatment for their lung cancer.
  • Patients with other types of cancer that are not under control.
  • Patients with serious heart problems.
  • Patients with active infections that require treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of allergic reactions to similar medications.
  • Patients with severe liver or kidney problems.
  • Patients who are unable to follow the study procedures.
  • Patients who are participating in another clinical trial.
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Investigated drugs

  • Lorlatinib

    is a medication used in this clinical trial as a single treatment option for patients with advanced ALK-positive non-small cell lung cancer (NSCLC). It is being tested to see if it can help patients live longer without their cancer getting worse compared to another treatment.

  • Crizotinib

    is another medication used in this trial as a single treatment for the same type of lung cancer. It is being compared to lorlatinib to determine which medication is more effective in delaying the progression of the disease in patients who have not received prior treatment.

What is already known about the treatment

  • Lorlatinib

    Lorlatinib is administered orally in tablet form. It is currently approved for use in treating advanced ALK-positive non-small cell lung cancer (NSCLC) and is well-documented in medical literature for this indication. The medication works by inhibiting the activity of the ALK protein, which is involved in the growth of cancer cells. Lorlatinib belongs to the class of drugs known as tyrosine kinase inhibitors, which block specific enzymes involved in cancer cell proliferation.

  • Crizotinib

    Crizotinib is also taken orally as a capsule. It is an established treatment for advanced ALK-positive non-small cell lung cancer, with extensive documentation in medical literature. Crizotinib functions by targeting and inhibiting the ALK protein, thereby preventing the growth and spread of cancer cells. It is classified as a tyrosine kinase inhibitor, similar to Lorlatinib, and is used to manage specific types of lung cancer.

Investigated diseases

Advanced 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 ALK (anaplastic lymphoma kinase) gene 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 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 ID2023-509169-19-00Protocol codeB7461006Estimated enrolment221 patientsSponsorPfizer Inc.

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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).