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Study of TAS3351 for Patients with Advanced Non-Small Cell Lung Cancer with EGFR Mutations

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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 specific changes in the EGFR gene, particularly the C797S mutation. The study is testing a new treatment called TAS3351, which is taken as a tablet. The purpose of the study is to explore the safety and effectiveness of TAS3351 in patients with advanced stages of this type of lung cancer.

The study is divided into different phases. Initially, the study will focus on finding the safest dose of TAS3351 and determining the best schedule for taking it. After establishing the appropriate dose, the study will further explore how well the treatment works in controlling the cancer. Participants will take the medication orally, and their health will be monitored throughout the study to assess the treatment’s impact.

In addition to the medication, a special test called the QIAGEN therascreen EGFR Plus RGQ PCR Kit will be used. This test helps identify specific changes in the EGFR gene, which can guide the treatment process. The study aims to provide valuable information about the potential benefits of TAS3351 for patients with this specific type of lung cancer.

1 initial visit

Upon joining the study, an initial visit is scheduled. During this visit, a detailed explanation of the study is provided, and written informed consent is obtained.

A series of tests are conducted to confirm eligibility, including assessments of organ function and overall health status.

2 treatment phase 1

The first phase of treatment involves taking the medication TAS3351 in tablet form. The dosage and frequency are determined based on safety assessments.

Regular monitoring is conducted to evaluate safety and determine the appropriate dose for the next phase.

3 treatment phase 2

In the second phase, the effectiveness of TAS3351 is assessed. The dosage is based on findings from the first phase.

Continued monitoring includes regular health check-ups and assessments of how the cancer responds to the treatment.

4 follow-up visits

After completing the treatment phases, follow-up visits are scheduled to monitor long-term effects and overall health.

These visits help in understanding the duration of response to the treatment and any potential side effects.

Who Can Join the Study?

  • Provide written informed consent, which means you agree to participate in the study after being informed about all aspects of it.
  • Be at least 18 years old or meet the legal adult age in your country.
  • Have a confirmed diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC) that cannot be removed by surgery.
  • Have received certain prior treatments, including no more than two lines of chemotherapy for advanced cancer.
  • Have a specific type of genetic change in the cancer called EGFR mutation, confirmed by a certified laboratory.
  • Have tumor tissue available for testing after the most recent treatment, if required.
  • Have measurable disease according to specific medical guidelines (optional for some participants).
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means you are fully active or have some symptoms but do not need to stay in bed for more than half of the day.
  • Have adequate organ function, which includes:
    • Enough white blood cells (absolute neutrophil count) and platelets in your blood.
    • Hemoglobin levels of at least 9.0 g/dL.
    • Liver enzymes (ALT and AST) within acceptable limits.
    • Total bilirubin within acceptable limits, unless you have a specific condition called Gilbert’s syndrome.
    • Kidney function with a creatinine clearance of at least 50 mL/min.
    • Potassium levels in your blood of at least 3.0 mmol/L.
  • Women who can become pregnant must have a negative pregnancy test before starting the study treatment.
  • Both men and women who can have children must agree to use highly effective birth control during the study and for a period after the last dose of study treatment (6 months for women, 3 months for men).

Who Cannot Join the Study?

  • Patients who do not have locally advanced or metastatic non-small cell lung cancer (NSCLC) with a specific genetic change called an acquired C797S epidermal growth factor receptor (EGFR) mutation.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who are not considered part of a vulnerable population, which means they do not need special protection or consideration in 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
Institut Gustave Roussy Villejuif France

Other Sites

Site Name City Country Status
Academisch Ziekenhuis Leiden Leiden The Netherlands
Netherlands Cancer Institute Amsterdam The Netherlands
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital Universitario 12 De Octubre Madrid Spain
Uxefigzrvs Hbbazbaa Cwvnbok Cologne Germany
Hythizkp Vdpo dtasdbae Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
11.07.2023
Germany Germany
Not recruiting
11.07.2023
Italy Italy
Not recruiting
11.07.2023
Spain Spain
Not recruiting
11.07.2023
The Netherlands The Netherlands
Not recruiting
11.07.2023

Trial locations

Investigated drugs:

TAS3351 is a new medication being studied for its potential to treat advanced non-small cell lung cancer, specifically in patients who have certain changes in a gene called EGFR. This medication is being tested to see if it is safe for patients to use and to find out the best dose to use in future studies. Researchers are also looking at how well it works to treat this type of lung cancer. The study is in its early stages, which means that the medication is still being tested to understand its effects and how it can help patients with this condition.

Investigated diseases:

Non-Small Cell Lung Cancer (NSCLC) with C797S EGFR Mutation – 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 is characterized by the uncontrolled growth of cells in the lung tissues. The C797S mutation in the epidermal growth factor receptor (EGFR) is an acquired genetic change that can occur in NSCLC, leading to resistance to certain targeted therapies. This mutation affects the progression of the disease by altering the cancer cells’ response to treatment. As the disease progresses, it can spread to other parts of the body, a process known as metastasis. The progression of NSCLC can vary, with some cases advancing more rapidly than others.

Trial ID:
2022-502595-23-00
Protocol code:
10073010
NCT ID:
NCT05765734
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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