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Study of Zipalertinib with Chemotherapy vs. Chemotherapy Alone for Patients with Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

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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 changes in the Epidermal Growth Factor Receptor (EGFR) gene, called Exon 20 insertion mutations. The study is investigating the effectiveness and safety of a new treatment approach that combines a medication called Zipalertinib with chemotherapy, compared to chemotherapy alone. Chemotherapy in this study includes drugs like Pemetrexed, Carboplatin, and Cisplatin, which are commonly used to treat various cancers.

The purpose of the study is to determine if adding Zipalertinib to the chemotherapy regimen can improve outcomes for patients who have not received prior treatment for their advanced or metastatic NSCLC. The study is divided into two parts. In the first part, researchers aim to find the best dose of Zipalertinib when used with chemotherapy. In the second part, they will compare how long patients live without their cancer getting worse between those receiving the combination treatment and those receiving only chemotherapy.

Participants in the study will receive treatment over a period of time, with regular monitoring to assess the effects of the treatment. The study will help to understand if the combination of Zipalertinib and chemotherapy offers a better treatment option for patients with this specific type of lung cancer. The trial is open-label, meaning both the researchers and participants know which treatment is being administered. The study aims to provide valuable information that could lead to improved treatment strategies for patients with advanced NSCLC.

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 one of two groups: one receiving zipalertinib with chemotherapy, and the other receiving chemotherapy alone.

    The study focuses on patients with advanced non-small cell lung cancer with specific genetic mutations.

  2. Step 2

    Treatment administration

    Patients in the zipalertinib group will take zipalertinib orally in tablet form. The dosage and frequency will be determined during the study.

    All patients will receive chemotherapy, which includes pemetrexed and a platinum agent such as carboplatin or cisplatin. These medications are administered intravenously as a solution for infusion.

  3. Step 3

    Treatment cycles

    The treatment is given in cycles. Each cycle's duration and the number of cycles will be specified during the study.

    Patients will be monitored for any side effects and the effectiveness of the treatment throughout the cycles.

  4. Step 4

    Monitoring and assessments

    Regular assessments will be conducted to monitor the patient's health and the progression of the disease.

    These assessments may include imaging tests and laboratory evaluations to ensure the treatment is working and to adjust dosages if necessary.

  5. Step 5

    End of treatment

    The study will continue until the estimated end date in November 2026, or until the patient completes the treatment cycles.

    After completing the treatment, follow-up assessments will be conducted to evaluate the long-term effects and outcomes of the treatment.

Who can join the trial?

13 criteria

  • Provide written informed consent, which means you agree to participate in the study after understanding all the details.
  • Have adequate organ function, which will be checked through lab tests to ensure your organs are working well enough.
  • Have a life expectancy of at least 3 months, as determined by the doctor conducting the study.
  • Women who can have children must have a negative pregnancy test before starting the study treatment. Women are not considered able to have children if they have gone through menopause (no periods for 12 months without another reason) or have had surgery to remove reproductive organs.
  • Both men and women who can have children must agree to use effective birth control during the study and for 6 months after the last dose of study treatment.
  • Be at least 18 years old or meet the legal adult age in your country, whichever is older.
  • Have a confirmed diagnosis of locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC), which means the cancer has spread beyond the lungs.
  • Have not received any prior systemic treatment for advanced or metastatic nonsquamous NSCLC. Previous treatment for early-stage NSCLC is allowed if it was more than 6 months before the study treatment. Certain previous treatments with specific drugs are allowed if they meet specific conditions, such as short treatment duration and no response to treatment.
  • Have documented EGFR mutation status, which means a specific genetic test has been done to check for changes in the EGFR gene.
  • Have available tumor tissue for testing, which means a sample of the cancer is available to check for specific genetic changes.
  • If you have brain metastases (cancer spread to the brain), you must have received treatment for them and have stable disease, meaning no new symptoms and no need for steroids for at least 2 weeks before joining the study. Small, symptom-free brain metastases may be allowed if immediate treatment is not needed.
  • Have at least one measurable lesion, which is a tumor that can be measured to see if it changes during the study. This is required for some parts of the study.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means you are fully active or have some symptoms but can still carry out light work.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have had previous treatment that might interfere with the study.
  • Patients with serious health conditions that could make participation unsafe.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures.
  • Patients who have allergies to the study medications.
  • Patients who are participating in another clinical trial.
  • Patients who have had a recent major surgery.
  • Patients with certain infections that could affect the study.
  • Patients who have a history of drug or alcohol abuse.
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Investigated drugs

  • Zipalertinib

    is a medication being studied for its effectiveness in treating patients with a specific type of lung cancer. It is used in combination with chemotherapy to see if it can help slow down the progression of the disease. This medication targets a mutation in the cancer cells, which may help stop them from growing.

  • Pemetrexed

    is a chemotherapy drug used in this trial. It works by interfering with the growth of cancer cells, slowing or stopping their spread. It is often used to treat certain types of lung cancer and is being tested in combination with other treatments to see if it improves patient outcomes.

  • Platinum Agent

    refers to a group of chemotherapy drugs that contain platinum. These drugs are used to damage the DNA of cancer cells, which can lead to their death. In this trial, a platinum agent is combined with other treatments to evaluate its effectiveness in treating lung cancer.

What is already known about the treatment

Zipalertinib – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating non-small cell lung cancer with specific genetic mutations. It is in the experimental phase and is not yet widely available in medical practice. The main therapeutic indication is for patients with non-small cell lung cancer that has specific mutations in the EGFR gene. Zipalertinib works by targeting and inhibiting the activity of the mutated EGFR protein, which is involved in the growth and spread of cancer cells. It is classified as a targeted therapy, specifically an EGFR inhibitor.

Investigated diseases

Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations – This is a type of lung cancer that begins in the cells lining the lungs and is characterized by specific genetic changes known as EGFR exon 20 insertion mutations. These mutations affect the epidermal growth factor receptor (EGFR), which plays a role in cell growth and division. The presence of these mutations can lead to uncontrolled cell growth, contributing to the development and progression of cancer. Non-small cell lung cancer is the most common type of lung cancer, and the presence of EGFR mutations can influence how the disease behaves. The progression of this cancer can vary, with some cases growing slowly while others may advance more rapidly. Understanding the specific genetic mutations involved is crucial for determining the most effective treatment strategies.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503575-21-00Protocol codeTAS6417-301Estimated enrolment337 patientsSponsorTaiho Oncology Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).