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Study on Afatinib and Osimertinib for Patients with EGFR-Mutated, T790M Negative Non-Squamous Non-Small Cell Lung Cancer in First-Line Treatment

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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) that has specific genetic changes called EGFR mutations but does not have the T790M mutation. The study is investigating the effectiveness and safety of two medications, afatinib and osimertinib, which are both taken as film-coated tablets. These medications are known as EGFR-Tyrosine kinase inhibitors, which work by blocking certain proteins that help cancer cells grow.

The purpose of the study is to compare the treatment sequence of taking afatinib first, followed by osimertinib, against taking osimertinib alone. Participants will be randomly assigned to one of these treatment groups. The study will last for up to 48 months, during which participants will take the medication orally. The study aims to see if the time until the cancer progresses is longer with the combination of afatinib followed by osimertinib compared to osimertinib alone.

Throughout the study, participants will be monitored for their response to the treatment, including how long they live without the cancer getting worse, their overall survival, and any side effects they experience. The study will also assess how the treatment affects participants' quality of life. This information will help determine the best treatment approach for patients with this type of lung cancer.

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 is confirmed to have non-squamous non-small cell lung cancer (NSCLC) with a specific genetic mutation known as EGFR mutation positive but T790M mutation negative.

    The patient must meet certain health criteria, including adequate organ function and a specific performance status, to ensure safety during the trial.

  2. Step 2

    Initial treatment phase

    The patient begins treatment with afatinib, which is administered orally. The dosage is determined based on the specific needs of the patient, with available options being 20 mg, 30 mg, or 40 mg film-coated tablets.

    This phase continues until the patient experiences a progression of the disease or unacceptable side effects.

  3. Step 3

    Subsequent treatment phase

    If the disease progresses or side effects are intolerable, the treatment is switched to osimertinib, also administered orally. The available dosages are 40 mg or 80 mg film-coated tablets.

    This phase aims to manage the disease effectively and is continued as long as it is beneficial for the patient.

  4. Step 4

    Monitoring and evaluation

    Throughout the trial, the patient's health and response to treatment are closely monitored. This includes regular assessments of disease progression and any side effects experienced.

    The effectiveness of the treatment is evaluated at specific intervals, such as 12 months and 24 months, to determine the response rate and disease control rate.

  5. Step 5

    Completion of the trial

    The trial is expected to conclude by November 2026. At this point, the overall survival and progression-free survival rates are analyzed to assess the long-term benefits of the treatment sequence.

    Patient-reported outcomes, including quality of life, are also considered to evaluate the impact of the treatment on daily living.

Who can join the trial?

14 criteria

  • The patient must have a type of lung cancer called non-squamous NSCLC with a specific change in the EGFR gene but not the T790M mutation.
  • The cancer must be at a stage that cannot be removed by surgery (unresectable) or has spread to other parts of the body (metastatic).
  • The patient should not have received a type of treatment called TKI for metastatic NSCLC, but previous chemotherapy before or after surgery is allowed.
  • There must be at least one area of cancer that can be measured according to specific guidelines (RECIST v1.1).
  • The patient must be 18 years of age or older.
  • The patient should have a general health status that allows them to perform daily activities, rated as 0 to 2 on the ECOG performance status scale.
  • The patient must have proper functioning of their organs, which includes:
    • A certain level of white blood cells called neutrophils (ANC ≥ 1500/mm³, or ANC > 1000/mm³ in special cases).
    • A platelet count of at least 75,000/mm³.
    • A kidney function measure called eGFR greater than 45 ml/min/1.73 m².
    • If there is a history of heart problems, the heart's pumping ability should be at least 50%.
    • A liver function test called total bilirubin should be no more than 1.5 times the normal limit (or 3 times if related to liver cancer spread).
    • Another liver function test, AST or ALT, should be no more than 3 times the normal limit (or 5 times if related to liver cancer spread).
    • The patient must have recovered from any side effects of previous treatments to a mild level (Grade 1 or less), except for stable mild nerve damage (Grade 2) and hair loss.
    • The patient must provide written consent to participate in the study.

Who cannot join the trial?

5 criteria

  • Patients who do not have a specific type of lung cancer called **EGFRmutated/T790M Mutation negative non-squamous NSCLC** cannot participate. This means the cancer does not have certain genetic changes.
  • Patients who are not in the age range specified for the study cannot participate. The study is looking for people in certain age groups.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for people with certain characteristics or conditions.
  • Both **male** and **female** patients can participate, but if a patient does not fit the gender criteria, they cannot participate.
  • Patients who are considered part of a **vulnerable population** cannot participate. This means people who might need special protection or care.
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Investigated drugs

  • Afatinib

    is a medication used in this clinical trial to treat patients with a specific type of lung cancer known as non-squamous non-small cell lung cancer (NSCLC) that has certain mutations. It is used as a first-line treatment to help control the growth of cancer cells by blocking the signals that tell the cancer cells to grow.

  • Osimertinib

    is another medication used in the trial, also for treating non-squamous non-small cell lung cancer (NSCLC) with specific mutations. It is used after afatinib in the treatment sequence to target cancer cells that have developed resistance to the initial treatment. This medication helps to further control the cancer by targeting and inhibiting the growth of these resistant cancer cells.

What is already known about the treatment

  • Afatinib

    Afatinib is administered orally in tablet form. It is currently used in the treatment of certain types of non-small cell lung cancer (NSCLC) that have specific mutations in the EGFR gene. The medication works by blocking the activity of the EGFR protein, which is involved in the growth and spread of cancer cells. Afatinib is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

  • Osimertinib

    Osimertinib is also taken orally as a tablet. It is approved for use in patients with non-small cell lung cancer (NSCLC) that has specific mutations in the EGFR gene, including the T790M mutation. The drug targets and inhibits the EGFR protein, which helps to slow down or stop the growth of cancer cells. Osimertinib belongs to the class of medications known as tyrosine kinase inhibitors, which are designed to target specific proteins involved in cancer cell growth.

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, leading to the formation of tumors. NSCLC is the most common type of lung cancer, accounting for about 85% of all cases. The disease progresses as the cancer cells grow and potentially spread to other parts of the body. Mutations in the EGFR gene, such as T790M, can influence the behavior and treatment response of the cancer. The progression of NSCLC can vary, with some cases remaining localized while others may metastasize to distant organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511625-55-00Protocol codeAFAMOSIEstimated enrolment126 patientsSponsorUniversitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

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