Study on the Effectiveness and Safety of Osimertinib for Patients with Early-Stage Non-Small Cell Lung Cancer After Tumor Removal

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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 genetic changes called EGFR mutations. These mutations are known as Ex19del and L858R. The study is for patients who have undergone surgery to completely remove the tumor. The treatment being tested is a medication called osimertinib, which is also known by its code name AZD9291. Osimertinib is taken in the form of film-coated tablets and is being compared to a placebo to see how effective it is in preventing the cancer from returning.

The purpose of the study is to assess how well osimertinib works in keeping the cancer from coming back after surgery. Participants in the study will be randomly assigned to receive either osimertinib or a placebo. The study will last for a period of up to 36 months, during which time participants will take the medication daily. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are not biased.

Throughout the study, the safety and side effects of osimertinib will be closely monitored. The main goal is to see if osimertinib can help patients live longer without the cancer returning, which is referred to as disease-free survival. The study will also look at overall survival rates and how the treatment affects participants’ physical functioning. By the end of the study, researchers hope to have a clearer understanding of the benefits and risks of using osimertinib for treating this type of lung cancer.

1 randomization

After confirming eligibility, participants are randomly assigned to receive either osimertinib or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

2 treatment administration

Participants receive the assigned treatment. If assigned to osimertinib, the dosage is either 40 mg or 80 mg, taken orally once daily. If assigned to the placebo, it is also taken orally once daily.

The treatment continues for a specified duration, which is determined by the study protocol and the participant’s response to the treatment.

3 regular assessments

Participants undergo regular assessments to monitor their health and the effectiveness of the treatment. These assessments include physical examinations, imaging tests, and laboratory tests.

The frequency and type of assessments are determined by the study protocol.

4 disease-free survival evaluation

The primary goal is to evaluate disease-free survival (DFS), which measures the length of time after treatment during which the participant remains free from cancer.

This evaluation is conducted by the study investigators and is a key measure of the treatment’s effectiveness.

5 secondary evaluations

Secondary evaluations include overall survival, impact on physical functioning, and central nervous system disease-free survival.

These evaluations help to provide a comprehensive understanding of the treatment’s impact on the participant’s health and quality of life.

6 safety and tolerability monitoring

Throughout the trial, the safety and tolerability of osimertinib versus placebo are closely monitored.

Any side effects or adverse reactions are documented and addressed according to the study protocol.

7 trial completion

Upon completion of the treatment period, participants undergo a final set of assessments to evaluate their overall health and the outcomes of the treatment.

The data collected during the trial is analyzed to determine the efficacy and safety of osimertinib compared to placebo.

Who Can Join the Study?

Must be a male or female who is at least 18 years old.
If female and able to have children, must use highly effective birth control and have a negative pregnancy test before starting the study. If not able to have children, must show proof. Male participants must agree to use barrier contraception.
Must have a type of lung cancer called non-small cell lung cancer (NSCLC) that is not of the squamous type.
Must have Stage IA2 or IA3 disease, which is a way to describe the size and spread of the cancer.
Must have had a complete surgical removal of the lung cancer through specific types of surgery like lobectomy, bilobectomy, segmentectomy, or sleeve resection.
Must have fully recovered from surgery at the time of joining the study. The study treatment cannot start until at least 4 weeks after surgery, and no more than 12 weeks should have passed since surgery.
Must have a World Health Organization performance status of 0 or 1, which means the person is fully active or has some symptoms but can still do light work.
Must provide a sample of the tumor for testing to check for specific risk factors and to confirm the presence of an EGFR mutation before joining the study.
The tumor must have one of the two specific EGFR mutations known as Ex19del or L858R.
Must have a minimum life expectancy of more than 6 months.

Who Cannot Join the Study?

Patients who have not had a complete removal of the tumor cannot participate.
Patients without the specific EGFR mutation type (Ex19del, L858R) are excluded. EGFR mutation refers to a change in a gene that can affect how cells grow.
Patients with a different stage of lung cancer than Stage IA2-IA3 are not eligible.
Patients who are not considered high-risk according to the study’s criteria cannot join.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Franziskus Hospital Harderberg	Georgsmarienhütte	Germany
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
ARNAS Garibaldi Di Catania	Catania	Italy
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Oncolab S.R.L.	Craiova	Romania
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Radiotherapy Center Cluj S.R.L.	Floresti	Romania
Klinikum Esslingen GmbH	Esslingen Am Neckar	Germany
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH	Berlin	Germany
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti	Bucharest	Romania
Ovidius Clinical Hospital S.R.L.	Ovidiu	Romania
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Hospital Clinico Universitario De Valencia	Valencia	Spain
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Ludwig Maximilian University Of Munich	Munich	Germany
Spitalul Universitar De Urgenta Bucuresti	Bucharest	Romania
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow	Poznan	Poland
Klinikum Wuerzburg Mitte gGmbH	Wuerzburg	Germany
Hospital Alvaro Cunqueiro	Vigo	Spain
Alsfqyd Ojtzsplpklk Ukclwjoopyvlv Puhtu	Parma	Italy
Iltveg Ifqlfyet Fhgkjcbilesxp Odbyuqixmvh	Rome	Italy
Nllhdwtm Iburcewuj Ow Tdkywhanxskt Adc Ledk Dzplxdho	Warsaw	Poland
Hvfzhvui Ubybgfacwovvr Rczctkeq Dv Mwvxjs	Malaga	Spain
Hrfkwgyn Dg Lt Skteu Cprw I Sdji Pke	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	09.08.2024
Italy	Not recruiting	09.08.2024
Poland	Not recruiting	09.08.2024
Romania	Not recruiting	09.08.2024
Spain	Not recruiting	09.08.2024

Trial locations

Investigated drugs:

Osimertinib

Osimertinib is a medication used in this clinical trial to help prevent the return of non-small cell lung cancer after surgery. It works by targeting specific mutations in the cancer cells, which can help stop the cancer from growing and spreading. This trial is testing how effective and safe osimertinib is for patients with certain genetic changes in their cancer.

Investigated diseases:

Non-small cell lung cancer

Non-small cell lung carcinoma – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma and squamous cell carcinoma. It is characterized by the uncontrolled growth of cells in the lung tissues, which can form tumors. The disease progresses by spreading to nearby tissues and potentially to other parts of the body. In the case of Stage IA2-IA3, the cancer is relatively small and has not spread to lymph nodes or distant sites. The presence of specific mutations, such as EGFR mutations (Ex19del, L858R), can influence the behavior of the cancer. Following complete tumor resection, monitoring for recurrence is crucial, as the disease can return even after initial treatment.

Trial ID:

2023-509943-28-00

Protocol code:

D516FC00001(ADAURA2)

NCT ID:

NCT05120349

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Osimertinib for Patients with Early-Stage Non-Small Cell Lung Cancer After Tumor Removal

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?