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Study Comparing Entrectinib and Crizotinib for Patients with Advanced Non-Small Cell Lung Cancer with ROS1 Gene Changes, With or Without Brain Metastases

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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 non-small cell lung cancer (NSCLC) that has a specific genetic change called the ROS1 gene rearrangement. This study is comparing two treatments: Entrectinib (also known by its code name RO 710-2122) and Crizotinib. Both medications are taken orally in the form of hard capsules. The purpose of the study is to evaluate how effective and safe these treatments are for patients with advanced or metastatic NSCLC, which means the cancer has spread to other parts of the body, including the brain.

Participants in the study will be randomly assigned to receive either Entrectinib or Crizotinib. The study will monitor the participants over a period of time to see how the cancer responds to the treatment and to check for any side effects. The study will also look at how long the participants live without the cancer getting worse and how the treatments affect their quality of life. Some participants may 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 on which treatment might be more beneficial for patients with this specific type of lung cancer. It will also help understand the impact of these treatments on the brain, as some patients may have cancer that has spread to the central nervous system. The results of this study could lead to better treatment options for people with ROS1-positive NSCLC in the future.

The research process

The trial runs in 6 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, a diagnosis of advanced or recurrent non-small cell lung cancer (NSCLC) with a specific gene rearrangement is confirmed.

    Eligibility is determined based on criteria such as no prior treatment with certain inhibitors or chemotherapy, and a life expectancy of at least 12 weeks.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either entrectinib or crizotinib.

    This process ensures that each participant has an equal chance of receiving either medication.

  3. Step 3

    Medication administration

    Participants take the assigned medication orally in the form of hard capsules.

    The specific dosage and frequency are determined by the study protocol and are monitored by the study team.

  4. Step 4

    Monitoring and assessments

    Regular assessments are conducted to monitor the progression of the disease and the participant's response to the medication.

    These assessments include imaging tests and evaluations of overall health and quality of life.

  5. Step 5

    Evaluation of outcomes

    The primary outcome measured is progression-free survival, which is the time until the disease progresses or the participant passes away.

    Secondary outcomes include overall response rate, duration of response, and overall survival, among others.

  6. Step 6

    Completion of the study

    The study is estimated to end in December 2027.

    Upon completion, the data collected will be analyzed to determine the efficacy and safety of the medications.

Who can join the trial?

8 criteria

  • Must have a confirmed diagnosis of advanced or recurrent non-small cell lung cancer (NSCLC) with a specific change in the ROS1 gene.
  • Must not have received any previous treatment with a ROS1 tyrosine kinase inhibitor, chemotherapy, or other treatments for advanced or recurrent NSCLC.
  • Previous radiotherapy is allowed if it was completed more than 14 days before joining the study.
  • Must have a measurable disease according to specific guidelines called RECIST v1.1, which are used to assess the size of tumors.
  • Can have measurable or non-measurable lesions in the central nervous system (CNS), including a condition called leptomeningeal carcinomatosis, which is cancer spread to the membranes surrounding the brain and spinal cord.
  • Must have a life expectancy of at least 12 weeks.
  • Both males and females are eligible to participate.
  • Participants from vulnerable populations are allowed to join the study.
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Investigated drugs

  • Entrectinib

    is a medication being studied for its effectiveness in treating patients with a specific type of lung cancer known as non-small cell lung cancer (NSCLC) that has a genetic change called ROS1 rearrangement. This medication is being tested to see how well it works in patients whose cancer has spread to the brain.

  • Crizotinib

    is another medication used in this study. It is already used to treat certain types of lung cancer, including those with ROS1 rearrangements. In this trial, it is being compared to entrectinib to see which one is more effective for patients with this type of lung cancer, especially when the cancer has also spread to the brain.

What is already known about the treatment

  • Entrectinib

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating non-small cell lung cancer (NSCLC) with specific genetic changes known as ROS1 gene rearrangements. It is designed to target and inhibit certain proteins involved in the growth and spread of cancer cells. Entrectinib is classified as a tyrosine kinase inhibitor, which works by blocking the action of enzymes that promote cancer cell proliferation. It is being compared to another medication, crizotinib, to determine its efficacy, especially in patients with cancer that has spread to the brain.

  • Crizotinib

    This medication is also taken orally and is well-established in medical literature as a treatment for non-small cell lung cancer with ROS1 gene rearrangements. It is used to manage cancer by inhibiting specific proteins that contribute to tumor growth. Crizotinib belongs to the pharmacological class of tyrosine kinase inhibitors, which help to slow down or stop the progression of cancer by blocking the signals that cause cancer cells to multiply. It is being evaluated against entrectinib in clinical trials to assess its effectiveness, particularly in cases where the cancer has metastasized to the central nervous system.

Investigated diseases

Non-small cell lung cancer with ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) gene rearrangements – This type of lung cancer is characterized by changes in the ROS1 gene, which can lead to abnormal cell growth. It is a subtype of non-small cell lung cancer, which is the most common type of lung cancer. The disease often begins in the cells lining the lungs and can spread to other parts of the body. Patients with this condition may experience symptoms such as coughing, 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 course. The presence of ROS1 gene rearrangements can influence the behavior of the cancer and its response to certain treatments.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507494-18-00Protocol codeMO41552Estimated enrolment206 patientsSponsorF. Hoffmann-La Roche AG

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