Study on the Effectiveness of Osimertinib for Patients with EGFR Mutant Non-Small Cell Lung Cancer Based on TP53 Mutation Status

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as EGFR mutant non-small cell lung cancer (NSCLC). This specific form of lung cancer involves changes in the EGFR gene, which can affect how cancer cells grow. The study is particularly interested in understanding how another gene, called TP53, influences the effectiveness of the treatment. The treatment being tested in this study is a medication called osimertinib, which is also known by its code name AZD9291. Osimertinib is taken as a film-coated tablet and is designed to target and block the activity of the EGFR gene mutations in cancer cells.

The purpose of this study is to evaluate how well osimertinib works in patients who have not received any previous treatment for their advanced EGFR mutant NSCLC. Participants in the study will take osimertinib orally, and the study will monitor their progress over time. The study aims to understand how the presence of the TP53 mutation affects the treatment’s success in controlling the cancer. The trial will follow patients to see how long they can live without the cancer getting worse, which is known as progression-free survival.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the cancer’s response to the treatment. These tests may include imaging techniques like computed tomography (CT) or magnetic resonance imaging (MRI) to measure the size of the cancer. The study will help gather important information on the effectiveness of osimertinib for patients with this specific type of lung cancer, potentially leading to better treatment options in the future.

1 initial consent and eligibility

You will provide informed consent, which means you agree to participate in the study after understanding all the details.

You must be over 18 years old and have a specific type of lung cancer called EGFR mutant NSCLC.

You will need to provide a sample of your tumor tissue for analysis.

You should not have received treatment for your advanced lung cancer before, except for certain therapies completed at least 6 months ago.

Your health status will be assessed to ensure you can participate, including a check that you have a life expectancy of at least 12 weeks.

2 medication administration

You will start taking a medication called osimertinib, which comes in the form of TAGRISSO 80 mg film-coated tablets.

The medication is taken orally, meaning you will swallow the tablet.

You will take the tablet once daily, at the same time each day, for the duration of the study.

3 regular monitoring and visits

You will have scheduled visits to the clinic for monitoring your health and the effects of the medication.

These visits will include examinations and possibly imaging tests like CT or MRI scans to measure the size of your tumor.

You will be required to comply with all scheduled visits and procedures as outlined in the study protocol.

4 follow-up and study completion

After completing the treatment phase, you will continue to be monitored for a period to assess the long-term effects of the medication.

The study is expected to end by December 30, 2025, but your participation may end earlier depending on your health and the study’s progress.

Who Can Join the Study?

Provide informed consent before any study-specific procedures.
Must be a male or female over 18 years of age.
Have locally advanced or metastatic EGFR mutant NSCLC (a type of lung cancer) that cannot be treated with surgery or radiotherapy. Must have a specific genetic change called EGFR exon 19 deletion or exon 21 p. L858R.
Provide a sample of tumor tissue for analysis.
Must not have received treatment for locally advanced or metastatic NSCLC and should be eligible for first-line treatment with osimertinib (a cancer medication). Previous treatments like chemotherapy or radiotherapy are allowed if they ended at least 6 months before joining the study.
Have a World Health Organization (WHO) performance status of 0-1, meaning you are fully active or have some symptoms but do not need bed rest.
Have a life expectancy of at least 12 weeks.
Females must use adequate birth control, not be breastfeeding, and have a negative pregnancy test if they can have children. They must show they cannot have children by being post-menopausal or having had certain surgeries.
Male patients should agree to use barrier contraception.
Be willing and able to follow the study protocol, including treatment, visits, and examinations.
Have at least one measurable lesion (a tumor that can be measured) that has not been treated with radiation, which is at least 10 mm in size (or 15 mm for lymph nodes) and can be measured accurately with a CT or MRI scan.

Who Cannot Join the Study?

Patients who do not have a mutation in the EGFR gene. EGFR stands for Epidermal Growth Factor Receptor, which is a protein that helps cells grow and divide.
Patients with a specific mutation in the TP53 gene. The TP53 gene helps control cell division and can prevent cancer.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
IRCCS Ospedale Sacro Cuore Don Calabria	Negrar di Valpolicella	Italy
Allufzd Olvixdkgzpe Uozxgkwtzgetd Pzmtv	Parma	Italy
Aumhmpe Ornnikpsqvj S Gzykruwk Alxdicqmzu	Rome	Italy
Adk Pmhgixiccoisvwhp Onjtkbbeyqq Pjgbawa	Pescara	Italy
Aug Oyxduopa Rtcjxkh Uqfmmrd Iwtpakaxwwknyqgjl dk Apsftf	Ancona	Italy
Ohsxhnkm Sfi Badtlep dy Vwafgpb	Vicenza	Italy
Ukgpafvhvo Djlyf Skkbg Dz Rqoe Lq Sxthegxh	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.09.2021

Trial locations

Investigated drugs:

Osimertinib

Osimertinib is a medication used in this clinical trial to treat patients with a specific type of lung cancer known as non-small cell lung cancer (NSCLC) that has certain genetic changes, specifically mutations in the EGFR gene. This medication works by targeting and blocking the activity of the EGFR protein, which is involved in the growth and spread of cancer cells. By inhibiting this protein, osimertinib can help slow down or stop the progression of the cancer, providing a potential treatment option for patients with this type of lung cancer.

Non-Small Cell Lung Cancer (NSCLC) – 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 typically begins in the tissues of 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 spreads to lymph nodes and other organs. As it advances, symptoms may include persistent cough, chest pain, and difficulty breathing. The progression rate can vary, and it often depends on genetic factors, such as mutations in the EGFR and TP53 genes. Understanding these mutations can help in studying the disease’s behavior and progression.

Trial ID:

2024-517424-18-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Osimertinib for Patients with EGFR Mutant Non-Small Cell Lung Cancer Based on TP53 Mutation Status

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?