Study on the Effectiveness and Safety of Osimertinib for Patients with Stage IB-IIIA 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) in its early stages, specifically stages IB to IIIA. The study is particularly interested in patients whose cancer has specific changes in the epidermal growth factor receptor (EGFR) gene, which are known to respond to certain treatments. The treatment being tested is a medication called osimertinib, also known by its code name AZD9291. This medication is compared to a placebo to evaluate its effectiveness and safety in preventing the return of cancer after the tumor has been completely removed through surgery, with or without additional chemotherapy.

The purpose of the study is to determine how well osimertinib works in keeping the cancer from coming back, which is referred to as disease-free survival. Participants in the study will be randomly assigned to receive either osimertinib or a placebo. The study will be conducted in a way that neither the participants nor the researchers know who is receiving the actual medication or the placebo, a method known as double-blind. This helps ensure that the results are not influenced by expectations about the treatment.

Throughout the study, participants will be monitored for several years to assess the long-term effects of the treatment. This includes regular check-ups and tests to track their health and any changes in their condition. The study will also look at overall survival rates and the quality of life of the participants, using questionnaires and other assessments. The safety of the treatment will be closely watched by checking for any side effects or health changes during the study period.

1 joining the study

Upon joining the study, the patient will be randomly assigned to receive either the medication osimertinib or a placebo. This process is double-blind, meaning neither the patient nor the researchers will know which treatment the patient is receiving.

2 medication administration

The patient will take the assigned medication orally in the form of film-coated tablets. If assigned osimertinib, the dosage will be either 80 mg or 40 mg, depending on the specific group assignment. The medication is to be taken once daily.

3 monitoring and assessments

Throughout the study, the patient’s health will be monitored through regular assessments. These include checking for disease-free survival, which means the time the patient remains free from cancer after treatment.

Additional assessments will be conducted at 2, 3, 4, and 5 years to evaluate the patient’s overall survival and quality of life. This will involve completing a health-related quality of life questionnaire.

4 safety evaluations

The safety and tolerability of the treatment will be assessed by monitoring any adverse events, changes in clinical chemistry, blood tests, urine tests, vital signs, physical examinations, body weight, heart function, and eye health.

5 study duration

The study is expected to continue until January 31, 2029. The patient’s participation will involve regular follow-ups and assessments throughout this period.

Who Can Join the Study?

  • Must be a male or female who is at least 18 years old.
  • Must have a confirmed diagnosis of primary non-small cell lung cancer (NSCLC), which is a type of lung cancer, with mostly non-squamous cells.
  • Must have had an MRI or CT scan of the brain before surgery, as this is a standard procedure.
  • After surgery, the cancer must be classified as Stage IB, II, or IIIA based on specific medical criteria.
  • The tumor must have one of the two common EGFR mutations, which are changes in the cancer cells that can affect treatment. These mutations are called Ex19del and L858R, and they may be present alone or with other mutations like T790M.
  • The primary lung cancer must have been completely removed through surgery, with no visible disease left. All edges of the removed tissue must be free of cancer.
  • Must have fully recovered from surgery and any standard treatments after surgery at the time of joining the study.
  • Must have a World Health Organization Performance Status of 0 to 1, which means the person is fully active or has some symptoms but can still carry out light work.
  • Female participants must use effective birth control, not be breastfeeding, and have a negative pregnancy test before starting the study drug. Alternatively, they must be unable to have children.

Who Cannot Join the Study?

  • Patients who have not had a complete removal of their lung tumor.
  • Patients who do not have the specific type of lung cancer called non-small cell lung carcinoma with certain EGFR mutations. EGFR mutations are changes in a gene that can affect how cancer grows.
  • Patients who have not been confirmed to have these mutations by a central lab.
  • Patients who have not reached the required stage of cancer, which is between Stage IB and Stage IIIA. These stages describe the size of the cancer and how far it has spread.
  • Patients who have not had surgery to remove their tumor, with or without additional treatment like chemotherapy. Chemotherapy is a type of cancer treatment that uses drugs to kill cancer cells.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Hospital Clinico San Carlos Madrid Spain
Centre Hospitalier Universitaire De Lille Lille France

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Hopital Tenon Paris France
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Region Oestergoetland Linkoping Sweden
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Instytut Msf Sp. z o.o. Lodz Poland
Szpital Rejonowy Im. Dr Jozefa Rostka W Raciborzu Raciborz Poland
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH Berlin Germany
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Mazowiecki Szpital Onkologiczny Sp. z o.o. Wieliszew Poland
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Kliniken der Stadt Koeln gGmbH Cologne Germany
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Klinikum Wuerzburg Mitte gGmbH Wuerzburg Germany
Vrije Universiteit Brussel Jette Belgium
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy Otwock Poland
Lungenfachklinik Immenhausen Immenhausen Germany
Aiezdwk Oybdczhqytf Uflwvozxmenqv Pmvle Parma Italy
Cnpgsx Luhy Bzbcis Lyon France
Iffmsyzf Rlzhspqyy Pmm La Slzmqo Dkt Tbrftj Dzvh Acxdlhn Ikrp Saagph Meldola Italy
Hgzcyiai Upfdhbaxnndyi Dgssdkvw Donostia / San Sebastian Spain
Ntakqfvk Injaaksi Okmvatzrs Iwh Mkipl Suvzdguopggfdzwivxncivfsumws Ikvysojo Bdblicjj Cracow Poland
Actazrx Uldmk Sapiituhc Lnvpna Dz Btgjspn Bologna Italy
Hbreqoyb Dy Ly Saotb Cpsp I Szti Pyf Barcelona Spain
Aowqaqn Oupbbvzinui Puix Gjgcyrfm Xnowu Bergamo Italy
Flanjmomb Pqhn Lx Iqqukxhpqoals Bsqqpnmxu Dlr Hrypzfng Utpjxwpsitywi La Pro Madrid Spain
Htajbdlc Vgsz dcoogduu Barcelona Spain

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
07.05.2024
France France
Not recruiting
07.05.2024
Germany Germany
Not recruiting
07.05.2024
Italy Italy
Not recruiting
07.05.2024
Poland Poland
Not recruiting
07.05.2024
Spain Spain
Not recruiting
07.05.2024
Sweden Sweden
Not recruiting
07.05.2024

Trial locations

Investigated drugs:

AZD9291: This is an investigational medication being studied for its effectiveness in treating patients with a specific type of lung cancer known as non-small cell lung carcinoma. It targets a mutation in the Epidermal Growth Factor Receptor (EGFR), which is often found in this type of cancer. The goal of using this medication is to prevent the cancer from returning after the tumor has been surgically removed.

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 as these tumors grow and potentially spread to other parts of the body. In the context of this study, the focus is on stages IB to IIIA, where the cancer is present in the lung and possibly nearby lymph nodes but has not spread to distant organs. The presence of specific EGFR mutations, such as Ex19del and L858R, is a key factor in the progression and behavior of the cancer. These mutations can influence how the cancer cells grow and respond to certain treatments.

Trial ID:
2023-506524-82-00
Protocol code:
ADAURA – D5164C00001
NCT ID:
NCT02511106
Trial Phase:
Therapeutic confirmatory (Phase III)

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