Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of Osimertinib and Chemotherapy for Patients with EGFR Mutation Positive Resectable Non-Small Cell Lung Cancer

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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) that can be surgically removed. The study is specifically for patients whose cancer has a mutation in the Epidermal Growth Factor Receptor (EGFR), which is a protein that can affect how cancer cells grow. The trial will explore the effectiveness of a medication called Osimertinib, also known by its code name AZD9291, used alone or in combination with chemotherapy, compared to chemotherapy alone. Chemotherapy drugs used in this study include Cisplatin, Carboplatin, and Pemetrexed. A placebo, which looks like the real medication but has no active ingredients, may also be used in some cases.

The purpose of the study is to determine how well Osimertinib works as a treatment before surgery, either by itself or with chemotherapy, compared to just using chemotherapy. Participants will receive treatment over a period of time, and their response to the treatment will be monitored. The study will involve taking the medication in the form of tablets or through an intravenous infusion, which means the medication is given directly into a vein.

Throughout the study, the main focus will be on how the cancer responds to the treatment, particularly looking at the number of cancer cells remaining after treatment. Other aspects, such as the overall survival of participants and any changes in their quality of life, will also be observed. The study aims to provide valuable information on the best treatment approach for patients with this specific type of lung cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    Eligibility criteria include being at least 18 years old, having a specific type of lung cancer that can be surgically removed, and having certain genetic mutations.

  2. Step 2

    Treatment group assignment

    Participants are randomly assigned to one of three treatment groups: osimertinib alone, osimertinib with chemotherapy, or chemotherapy alone.

    Osimertinib is a medication taken orally, while chemotherapy involves drugs administered intravenously.

  3. Step 3

    Treatment phase

    For those receiving osimertinib alone, the medication is taken as a 40 mg or 80 mg film-coated tablet daily.

    Participants in the combination group receive osimertinib along with chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed, administered intravenously.

    The chemotherapy alone group receives cisplatin, carboplatin, and pemetrexed intravenously.

  4. Step 4

    Surgery

    After the treatment phase, surgery is performed to remove the lung cancer.

    The goal is to achieve a complete surgical resection of the cancer.

  5. Step 5

    Post-surgery assessment

    Following surgery, an assessment is conducted to evaluate the response to treatment.

    This includes checking for any remaining cancer cells in the removed tissue.

  6. Step 6

    Follow-up

    Regular follow-up visits are scheduled to monitor health and any signs of cancer recurrence.

    These visits may include physical exams, imaging tests, and blood tests.

Who can join the trial?

5 criteria

  • Must be a male or female who is at least 18 years old. If under 20 years old and in Japan, written consent is needed from both the patient and a legal representative.
  • Must have a type of lung cancer called non-squamous NSCLC that can be completely removed by surgery. This is determined by a team of doctors, including a lung surgeon.
  • The cancer must be at a stage where complete surgical removal is possible, as evaluated by a team of specialists.
  • Must have an ECOG PS score of 0 or 1. This is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
  • The tumor must have specific changes in the EGFR gene, which are known to respond to certain treatments. These changes include Ex19del, L858R, and possibly others like T790M, G719X, Exon20 insertions, S7681, and L861Q.

Who cannot join the trial?

5 criteria

  • Patients who do not have a type of lung cancer called non-squamous NSCLC that can be completely removed by surgery.
  • Patients whose lung cancer is not in stages II to IIIB N2. These stages describe how much the cancer has spread.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to receive the study treatments safely.
  • Patients who are part of a vulnerable population that the study cannot safely include.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Osimertinib

    is a medication used in this trial as a treatment for patients with a specific type of lung cancer that has a mutation in the epidermal growth factor receptor (EGFR). It is being tested to see how effective it is when used alone or in combination with chemotherapy before surgery.

  • Chemotherapy

    is a standard cancer treatment that uses drugs to kill cancer cells or stop them from growing. In this trial, chemotherapy is used as a comparison to see how well it works on its own versus when combined with osimertinib for treating patients with EGFR mutation-positive lung cancer before surgery.

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 non-small cell lung cancer (NSCLC) with specific genetic mutations. The main therapeutic indication is for patients with resectable NSCLC that have mutations in the epidermal growth factor receptor (EGFR). At the molecular level, osimertinib works by inhibiting the activity of the EGFR, which is often overactive in certain types of cancer cells, leading to their growth and division. It is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the lung tissues, which can form tumors. NSCLC is known for its slower growth compared to small cell lung cancer, and it often spreads to other parts of the body. The disease is staged from I to IV, with Stage II to IIIB indicating more advanced local spread but not distant metastasis. Symptoms may include persistent cough, chest pain, and difficulty breathing. The progression of NSCLC can vary, with some cases remaining localized while others may spread to lymph nodes or other organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502606-33-00Protocol codeD516AC00001Estimated enrolment335 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.