RecruitingRare disease

Study of Taletrectinib for Patients with Advanced or Metastatic ROS1 Positive Non-Small Cell Lung Cancer

Verified siteInvestigationalNo 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 the effects of a medication called Taletrectinib in patients with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) and other solid tumors that are positive for a specific genetic change known as ROS1. The purpose of the study is to evaluate how effective and safe Taletrectinib is for these patients. Taletrectinib is taken orally in the form of a capsule.

The study is designed to observe the response of the cancer to the treatment with Taletrectinib. Patients participating in the study will receive the medication and will be monitored over a period of time to assess how their cancer responds. The study will also look at the safety of the medication, which means checking for any side effects that might occur. Some patients in the study may receive a placebo, which is a substance with no active medication, to compare the effects of Taletrectinib.

Throughout the study, patients will have regular visits to the clinic for check-ups and tests to monitor their health and the progress of their cancer. These visits will help the researchers understand how well Taletrectinib works and how safe it is for patients with ROS1-positive cancers. The study aims to provide valuable information that could lead to better treatment options for patients with these types of cancers 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.

Step 1
Initial visit
Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on specific criteria, including age, health status, and medical history.
A physical examination is conducted, and blood samples are taken to assess organ function and overall health. A pregnancy test is performed for females of childbearing potential.
Step 2
Treatment initiation
The treatment phase begins with the administration of the study medication, taletrectinib. This medication is provided in capsule form and is taken orally.
The dosage and frequency of taletrectinib are determined by the study protocol and are explained in detail by the healthcare team.
Step 3
Regular follow-up visits
Regular follow-up visits are scheduled to monitor health and response to the treatment. These visits include physical examinations, blood tests, and imaging studies to assess the progress of the disease.
The healthcare team evaluates any side effects or changes in health status and adjusts the treatment plan as necessary.
Step 4
Ongoing monitoring
Throughout the study, ongoing monitoring is conducted to ensure safety and effectiveness of the treatment. This includes regular communication with the healthcare team and reporting any new symptoms or concerns.
Participants are required to adhere to the study schedule and follow the instructions provided by the healthcare team.
Step 5
End of treatment
At the end of the treatment period, a final evaluation is conducted. This includes a comprehensive assessment of health status and the effectiveness of the treatment.
Participants may be asked to return for additional follow-up visits to monitor long-term effects and overall health.

Who can join the trial?

15 criteria

Must be at least 18 years old (or 20 years old if required by local rules).
Must have a life expectancy of at least 12 weeks as judged by the study doctor.
Both males and females can participate. Males must agree to use effective birth control or abstain from sex during the study and for 90 days after the last dose. Females must use two effective birth control methods or abstain from sex from the time of consent until 45 days after the last dose.
Females of childbearing potential must have a negative pregnancy test within 7 days before starting the study treatment.
Must be willing and able to provide written informed consent.
Must be willing and able to attend scheduled visits, follow treatment plans, and undergo tests and procedures.
Must be willing and able to follow the study site's COVID-19 policies.
Must have adequate organ function, including specific levels for liver enzymes, bilirubin, blood cell counts, and kidney function.
Must have a confirmed diagnosis of locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) or other solid tumors.
Must have evidence of ROS1 fusion in their cancer, confirmed by specific laboratory tests.
Must provide enough tumor tissue for testing, either from previous samples or a new biopsy if needed.
Patients with central nervous system (CNS) involvement are allowed if the condition is stable and controlled.
Must be either ROS1 TKI treatment naive or have been treated with prior ROS1 TKI(s) as specified for different patient groups.
Must have at least one measurable disease as assessed by the study doctor.
Must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but able to carry out light work.

Who cannot join the trial?

8 criteria

Patients who do not have Non-small Cell Lung Cancer cannot participate.
Patients who do not have advanced or metastatic ROS1 positive NSCLC cannot participate. Metastatic means the cancer has spread to other parts of the body.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are not willing or able to follow the study procedures cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have allergies or reactions to the study medication cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Naples, Italy
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Responsive
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy

Trial locations

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Investigated drugs

Taletrectinib is a medication being studied for its potential to treat certain types of cancer, specifically advanced or metastatic ROS1 positive non-small cell lung cancer (NSCLC) and other solid tumors. It works by targeting and blocking specific proteins that help cancer cells grow and spread. By inhibiting these proteins, taletrectinib may help to slow down or stop the progression of the cancer, providing a potential treatment option for patients with these types of tumors.

Taletrectinib

What is already known about the treatment

Taletrectinib – Taletrectinib is administered orally in the form of tablets and is currently being studied in clinical trials for its effectiveness and safety in treating advanced or metastatic non-small cell lung cancer (NSCLC) that is positive for the ROS1 gene, as well as other solid tumors. It is not yet widely used in medicine, as it is still under investigation. The main therapeutic indication for taletrectinib is for patients with ROS1-positive NSCLC. At the molecular level, taletrectinib works by inhibiting the activity of specific proteins that promote cancer cell growth, thereby slowing down or stopping the progression of the disease. It is classified pharmacologically as a tyrosine kinase inhibitor, which is a type of targeted cancer therapy.

Investigated diseases

Non-small Cell Lung Cancer – Non-small Cell Lung Cancer (NSCLC) is a group of lung cancers that behave similarly and are the most common type of lung cancer. It typically begins in the epithelial cells lining the lungs and can spread to other parts of the body. The disease progresses through stages, starting from a localized tumor to more advanced stages where it may invade nearby tissues or spread to distant organs. NSCLC is often categorized into subtypes, including adenocarcinoma, squamous cell carcinoma, and large cell carcinoma, based on the type of cells involved. As the disease advances, symptoms such as persistent cough, chest pain, and difficulty breathing may become more pronounced. The progression of NSCLC can vary significantly among individuals, influenced by factors such as genetic mutations and environmental exposures.