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Study for Patients with Various Tumor Types Continuing Osimertinib Treatment After Previous Oncology Study Completion

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What is this study about?

This clinical trial is focused on patients with various types of tumors who have previously participated in an oncology study. The treatment being studied is called osimertinib, also known by its brand name TAGRISSO. This medication is available in the form of film-coated tablets and is taken orally. The purpose of the study is to continue providing treatment to patients who are still benefiting from osimertinib after completing a previous study, while also monitoring the safety and how well patients tolerate the medication.

Participants in this study will continue to receive osimertinib as long as they are benefiting from it, according to the judgment of their doctor. The study will keep track of any serious side effects that occur up to 28 days after the last dose of the medication. The study is designed to ensure that patients who are doing well on osimertinib can continue their treatment without interruption.

This trial is part of a larger effort to understand how osimertinib can help patients with different types of tumors. The study will run until March 2026, and it began recruiting participants in June 2023. The goal is to provide ongoing treatment to those who need it while gathering important information about the medication’s safety and effectiveness.

1 joining the study

Upon joining the study, ensure that a signed and dated written informed consent form is provided. This document confirms understanding and agreement to participate in the study.

Confirm that you are currently benefiting from the treatment with osimertinib (TAGRISSO) as part of a previous study. This will be assessed by the study investigator.

2 medication details

Continue taking osimertinib (TAGRISSO) as prescribed. The medication is available in two forms: 80 mg and 40 mg film-coated tablets.

The medication is taken orally. Follow the dosage and frequency as advised by the healthcare provider.

3 safety monitoring

Throughout the study, safety and tolerability of the medication will be monitored. This involves regular check-ups and reporting any side effects experienced.

Serious adverse events (SAEs) and serious adverse events of special interest (AESIs) will be recorded until 28 days after the last dose of the study treatment.

4 contraceptive measures

If you are a female of childbearing potential, use adequate contraceptive measures during the study.

Male participants should be willing to use barrier contraception, such as condoms, during the study.

5 study duration

The estimated end date for the study is March 31, 2026. Continue participating in the study as long as you are benefiting from the treatment and as advised by the healthcare provider.

Who Can Join the Study?

  • Provide a signed and dated written consent form to participate in the study.
  • The patient must currently be benefiting from treatment with osimertinib (TAGRISSO), as determined by the study doctor. This treatment should have been part of a previous study that has ended or stopped.
  • If the patient is a female who can have children, she should use effective birth control methods. Male patients should be willing to use barrier contraception, such as condoms.

Who Cannot Join the Study?

  • Patients who have not completed the previous clinical trial they were part of.
  • Patients who have experienced severe side effects from the study medication in the previous trial.
  • Patients with any other medical condition that might interfere with the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who are not willing to use effective birth control methods during the study.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients with a history of allergic reactions to the study medication or similar drugs.
  • Patients with severe heart problems.
  • Patients with uncontrolled high blood pressure.
  • Patients with active infections that require treatment.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures or attend the required visits.

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
One Day Med Sp. z o.o. Szczecin Poland

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

Trial status

Country Status Recruitment Start
France France
Recruiting
01.06.2023
Poland Poland
Recruiting
01.06.2023

Trial locations

Investigated drugs:

Osimertinib (TAGRISSO) is a medication used in the treatment of certain types of lung cancer. It works by targeting and blocking specific proteins that help cancer cells grow and spread. This medication is often used when other treatments have not been effective, and it is designed to help control the disease and improve symptoms. In this clinical trial, patients who have already been treated with Osimertinib and are still benefiting from it will continue to receive the medication to maintain their health and monitor any side effects.

Investigated diseases:

Various tumor types – Tumors are abnormal growths of tissue that can occur in any part of the body. They can be benign, meaning they do not spread to other parts of the body, or malignant, which means they can invade nearby tissues and spread to other areas. Tumors develop when cells grow uncontrollably and do not die when they should. The progression of tumors varies depending on their type and location. Some tumors grow slowly and may not cause symptoms for a long time, while others can grow rapidly and cause significant health issues. The behavior and impact of a tumor depend on its specific characteristics and the body’s response to it.

Trial ID:
2022-501528-58-00
Protocol code:
D5161N00007
Trial Phase:
Therapeutic confirmatory (Phase III)

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