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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Hôpital Européen Georges-Pompidou	Paris	France
Hospital Clinico San Carlos	Madrid	Spain
Aix Marseille University	Marseille	France
Institut Gustave Roussy	Villejuif	France

Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Instytut Centrum Zdrowia Matki Polki	Lodz	Poland
Institut Godinot	Reims	France
Micancer Center S.L.P.	Barcelona	Spain
Hospital Universitario Ramon Y Cajal	Madrid	Spain
Hospital Clinico Universitario De Valencia	Valencia	Spain
Hospital Universitario Virgen Macarena	Sevilla	Spain
Ospedale San Raffaele S.r.l.	Milan	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Hôpital Pontchaillou-CHU Rennes	Rennes	France
Caqgqj Lmeo Busemi	Lyon	France
Ijrwzlee Citnav Dbvewssvibhvktifa	L'hospitalet De Llobregat	Spain
Hfreqedy Unwrbbolnehhf Rkiicyfo Dp Mtkndl	Malaga	Spain
Fkgyqltsc Prnd Lf Ipfxpwgnrxztj Bjzwskyhf Dds Hiluldnh Uxqlokuqjyhcq Lz Phr	Madrid	Spain
Hhhzxcck Vitm deppeges	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	08.08.2022
Italy	Not recruiting	08.08.2022
Poland	Not recruiting	08.08.2022
Spain	Not recruiting	08.08.2022

Trial locations

Investigated drugs:

Taletrectinib

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.

Investigated diseases:

Non-small cell lung cancer recurrent

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.

Trial ID:

2024-516604-41-00

Protocol code:

AB-106-G208

NCT ID:

NCT04919811

Trial Phase:

Therapeutic exploratory (Phase II)

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

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