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Study of Repotrectinib for Frail or Elderly Patients with Advanced Non-Small Cell Lung Cancer with ROS1 Gene Rearrangement

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as non-small-cell lung cancer (NSCLC) that has a specific change in its genes called ROS1 gene rearrangement. The study is testing a medication called Repotrectinib (TPX-0005), which is taken as a hard capsule. The purpose of the study is to see how well Repotrectinib works in treating this type of lung cancer, especially in patients who are older or have a lower ability to perform daily activities.

Participants in the study will take Repotrectinib by mouth. The study will observe how the cancer responds to the treatment over time. This includes checking if the cancer shrinks or stops growing. The study will also look at how long patients live without the cancer getting worse and how the treatment affects their overall quality of life. Some patients may receive a placebo, which is a substance with no active medication, to compare the effects of Repotrectinib.

The study will last for several years, and during this time, patients will have regular check-ups and tests to monitor their health and the cancer’s response to the treatment. The goal is to gather information that could help improve treatment options for people with this specific type of lung cancer. Participants will be closely monitored by a team of healthcare professionals throughout the study to ensure their safety and well-being.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s objectives and procedures. The patient must provide written consent to participate in the study.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes verifying the diagnosis of advanced non-small-cell lung cancer (NSCLC) with an ROS1 gene rearrangement and ensuring adequate organ function and blood counts.

3 treatment initiation

The patient will begin treatment with repotrectinib, administered orally in the form of hard capsules. The dosage and frequency will be determined by the study protocol.

4 regular monitoring

Throughout the study, the patient will attend regular appointments for monitoring. This includes assessing the response to treatment using imaging techniques and evaluating any side effects.

5 response evaluation

The patient’s response to the treatment will be evaluated based on the criteria set by the study. This involves determining if there is a complete or partial response to the treatment.

6 continuation or adjustment of treatment

Depending on the patient’s response and any side effects experienced, the treatment plan may be continued or adjusted. This decision will be made by the study team based on the patient’s condition.

7 end of treatment

The treatment will continue until the study’s end date or until the patient experiences disease progression or unacceptable side effects. The estimated end date for the study is August 31, 2031.

8 follow-up

After completing the treatment, the patient will have follow-up visits to monitor their health and any long-term effects of the treatment.

Who Can Join the Study?

  • Must be at least 18 years old.
  • Expected to live for at least 3 more months.
  • Must be part of a suitable social security system.
  • Must have good blood and organ function, which includes:
    • Enough white blood cells and platelets without needing extra support or transfusions.
    • Hemoglobin level of at least 9.0 g/dL (can receive transfusions to meet this).
    • Normal blood clotting levels unless on blood thinners, which should be stable.
    • Liver enzymes and other markers within specific limits, with some exceptions for liver or bone conditions.
    • Kidney function with a creatinine clearance of at least 45 mL/min.
  • Must use a reliable method of birth control during the study:
    • Women must avoid pregnancy and use effective birth control during and for 2 months after the study.
    • Men must use condoms during and for 4 months after the study, even if they had a vasectomy.
  • Must have a confirmed diagnosis of advanced or spreading non-small-cell lung cancer (NSCLC) with a specific gene change called ROS1 gene rearrangement.
  • Must agree to and be able to provide written consent to participate in the study.
  • Must have at least one measurable tumor according to specific criteria, including those in the central nervous system (CNS).
  • Previous chemotherapy for advanced cancer is allowed, but there must be a break of at least 14 days or 5 half-lives (whichever is shorter) before starting the study treatment. For certain drugs, a 42-day break is required.
  • Previous immunotherapy is allowed, but there must be a 14-day break before starting the study treatment, and any side effects must be resolved.
  • For those who have not taken a specific type of drug called ROS1 TKI, they can join the study.
  • For those who have taken ROS1 TKI before, they can join if no more than 30% of participants have done so. There must be a 7-day break or 5 half-lives (whichever is shorter) since the last dose, and side effects must be resolved.
  • People with symptoms in the CNS or a condition called leptomeningeal carcinomatosis can participate.

Who Cannot Join the Study?

  • Patients with a different type of cancer than the one specified in the study.
  • Patients who do not have the specific genetic change called ROS1 gene rearrangement. This is a change in the DNA that can affect how cancer grows.
  • Patients who are not in the age range specified for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who do not meet the specific health conditions required for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Intercommunal Creteil Creteil France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier De Colmar Colmar France
Centre Hospitalier Universitaire Rouen Rouen France
Hospital Foch Suresnes France
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis Aix En Provence France
HIA Sainte Anne Toulon France
Centre Hospitalier Metropole Savoie Chambery France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Centre Francois Baclesse Caen France
Les Hopitaux Nord-Ouest Villefranche sur Saône France
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Cceciz Hpabffblewg Rwwklxfr Depungrwwczwtv Angers France

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Trial status

Country Status Recruitment Start
France France
Recruiting
01.09.2024

Trial locations

Investigated drugs:

Repotrectinib is a medication being studied for its effectiveness in treating patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic change known as ROS1 rearrangement. This study focuses on patients who are either frail or elderly. The goal is to see how well the cancer responds to this treatment, using specific criteria to measure any reduction in tumor size.

Investigated diseases:

Stage III/IV Non-Small-Cell Lung Cancer (NSCLC) with ROS1 Gene Rearrangement – This is a type of lung cancer that occurs when cells in the lung grow uncontrollably, forming tumors. It is classified as non-small-cell, which is the most common type of lung cancer, and is characterized by a specific genetic change known as ROS1 gene rearrangement. This genetic alteration can drive the growth of cancer cells. In stages III and IV, the cancer has spread beyond the lungs to other parts of the body, making it more advanced. The progression of this disease involves the growth and spread of cancerous cells, which can lead to symptoms such as coughing, chest pain, and difficulty breathing. The disease’s progression is monitored through imaging and other assessments to evaluate the response to treatment.

Trial ID:
2023-509073-23-00
Protocol code:
REPOROS GFPC 04-2023
Trial Phase:
Therapeutic exploratory (Phase II)

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