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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

9 criteria

  • 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 trial?

5 criteria

  • 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.
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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.

What is already known about the treatment

Osimertinib – Osimertinib is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating certain types of lung cancer, specifically stage IB-IIIA non-small cell lung carcinoma with specific EGFR mutations. The medication works by targeting and inhibiting the activity of the epidermal growth factor receptor (EGFR) with mutations, which are often involved in the growth and spread of cancer cells. Osimertinib is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506524-82-00Protocol codeADAURA - D5164C00001Estimated enrolment499 patientsSponsorAstraZeneca AB

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