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Study Comparing Repotrectinib and Crizotinib for Patients with Advanced or Metastatic ROS1-positive Non-Small Cell Lung Cancer

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 Non-Small Cell Lung Cancer (NSCLC). The study is specifically looking at cases where the cancer is locally advanced or has spread to other parts of the body, and where patients have a specific genetic feature called ROS1-positive. The trial will compare two treatments: Repotrectinib (TPX-0005) and Crizotinib. Both of these medications are taken orally in the form of hard capsules and are designed to target and inhibit certain proteins that help cancer cells grow.

The purpose of this study is to see how well these treatments work in preventing the cancer from getting worse. Participants in the trial will be randomly assigned to receive either Repotrectinib or Crizotinib. The study will monitor the participants over time to assess the effectiveness of the treatments in controlling the cancer. This will involve regular check-ups and assessments by medical professionals to track the progress of the disease and any side effects from the medications.

Throughout the study, the main focus will be on how long the participants can live without their cancer progressing, which is known as progression-free survival. Other aspects being studied include overall survival, how well the cancer responds to the treatment, and the duration of this response. The trial will also look at the time it takes for the treatment to start working and any potential side effects. The study aims to provide valuable information that could help improve treatment options for people with this type of lung cancer in the future.

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, you will be randomly assigned to receive either Repotrectinib or Crizotinib. This is to compare the effectiveness of these medications in treating your condition.

  2. Step 2

    Medication administration

    If assigned to Repotrectinib, you will take it orally in the form of hard capsules. The specific dosage and frequency will be provided by the study team.

    If assigned to Crizotinib, you will also take it orally in the form of hard capsules. The dosage could be either 250 mg or 200 mg, and the frequency will be specified by the study team.

  3. Step 3

    Regular check-ups

    Throughout the study, regular check-ups will be scheduled to monitor your health and the effectiveness of the treatment. These check-ups will include various tests and assessments as determined by the study protocol.

  4. Step 4

    Progress evaluation

    Your progress will be evaluated based on Progression Free Survival (PFS), which measures the time during and after treatment that you live with the disease without it getting worse.

    Other evaluations will include overall survival, response rates, and any side effects experienced during the trial.

  5. Step 5

    Completion of the study

    The study is expected to continue until July 25, 2031. Upon completion, you will have a final assessment to evaluate the overall impact of the treatment.

Who can join the trial?

8 criteria

  • The participant must have a confirmed diagnosis of locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). This means the cancer has spread beyond the lungs.
  • The participant must have a ROS1 gene rearrangement/fusion. This is a specific change in the genes that can be detected by a test.
  • The participant must have at least one measurable tumor or lesion, which is a growth or area of disease that can be measured by the doctor.
  • The participant must not have been treated before with certain drugs called TKIs that work on ROS1-positive NSCLC.
  • The participant can have had up to one previous treatment for NSCLC.
  • The participant must have an ECOG Performance Status of 0, 1, or 2. This is a scale that measures how well a person can perform daily activities. A lower number means the person is more active.
  • Both male and female participants are eligible.
  • Participants from vulnerable populations are eligible.

Who cannot join the trial?

9 criteria

  • Patients with any other type of cancer besides Non-Small Cell Lung Cancer (NSCLC) cannot participate.
  • Patients who have had another cancer within the last 3 years, except for certain skin cancers or in situ cervical cancer, are excluded.
  • Patients who have received certain treatments for NSCLC, such as chemotherapy or targeted therapy, within a specific time frame before the study starts, are not eligible.
  • Patients with uncontrolled or severe heart conditions, such as heart failure or irregular heartbeats, cannot join the study.
  • Patients with active infections that require treatment with antibiotics or antiviral medications are excluded.
  • Patients with known allergies to the study drugs or similar drugs cannot participate.
  • Patients who are pregnant or breastfeeding are not eligible for the study.
  • Patients who have participated in another clinical trial within a certain period before this study starts are excluded.
  • Patients with any condition that the study doctors believe would make it unsafe for them to participate are not eligible.
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Investigated drugs

  • Repotrectinib

    is a medication being studied for its potential to treat a type of lung cancer known as non-small cell lung cancer (NSCLC) that is positive for a specific protein called ROS1. This medication works by blocking certain proteins in cancer cells that help them grow and spread. By doing this, repotrectinib may help to slow down or stop the progression of the cancer.

  • Crizotinib

    is another medication used in this study, which is already approved for treating certain types of lung cancer. It targets and blocks specific proteins in cancer cells, similar to repotrectinib, to help prevent the cancer from growing and spreading. In this trial, crizotinib is being compared to repotrectinib to see which one is more effective in treating patients with ROS1 positive non-small cell lung cancer.

What is already known about the treatment

  • Repotrectinib

    Repotrectinib is administered orally in the form of a pill. It is currently being studied in clinical trials for its effectiveness in treating non-small cell lung cancer (NSCLC) that is positive for ROS1, a specific genetic marker. The main therapeutic use of repotrectinib is to slow down or stop the progression of this type of lung cancer. At the molecular level, it works by blocking certain proteins called tyrosine kinases, which are involved in the growth and spread of cancer cells. Repotrectinib is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

  • Crizotinib

    Crizotinib is also taken orally as a pill and is an established medication used in the treatment of non-small cell lung cancer (NSCLC) with specific genetic changes, such as ROS1 positivity. It is used to manage and control the progression of this cancer. Crizotinib works by inhibiting the activity of certain proteins known as tyrosine kinases, which play a role in the growth and division of cancer cells. It belongs to the pharmacological class of tyrosine kinase inhibitors, which are designed to target and block these proteins to help control cancer.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC) – Non-Small Cell Lung Cancer is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It generally starts in the tissues of the lungs and can spread to other parts of the body. The disease progresses as cancer cells grow uncontrollably, forming tumors that can interfere with normal lung function. As it advances, it may invade nearby tissues and organs, potentially spreading to lymph nodes and other areas. The progression can lead to symptoms like persistent cough, chest pain, and difficulty breathing. Over time, the disease can affect the overall health and function of the respiratory system.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505604-32-00Protocol codeCA127-1030Estimated enrolment317 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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