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Study Comparing DZD9008 and Chemotherapy for First-Line Treatment in Patients with Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Mutation

Verified siteRegistered drugNo placebo
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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 a specific genetic change called the Epidermal Growth Factor Receptor Exon 20 Insertion Mutation. The study is comparing two treatments for this condition. One treatment is a new medication called Sunvozertinib, also known by its code name DZD9008. The other treatment is a standard approach using a combination of chemotherapy drugs, which includes Carboplatin and another drug called Pemetrexed. These chemotherapy drugs are given through an infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to see how well Sunvozertinib works compared to the standard chemotherapy treatment in patients who have not received any previous treatment for their advanced or spreading NSCLC. Participants in the study will be randomly assigned to receive either Sunvozertinib in tablet form or the chemotherapy drugs through infusion. The study will monitor the participants over a period to assess the effectiveness of the treatments in controlling the cancer.

Throughout the study, participants will undergo regular check-ups and tests, including imaging scans like MRI or CT scans, to track the progress of their cancer. The study aims to provide valuable information on the potential benefits of Sunvozertinib as a first-line treatment option for this specific type of lung cancer. Participants may also receive a placebo, which is a substance with no active medication, as part of the study design.

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, you will be asked to provide a signed and dated, written informed consent form. This confirms that you understand the nature of the trial and agree to participate.

    You will undergo initial assessments to confirm eligibility, including tests to verify the presence of a specific mutation in your lung cancer.

  2. Step 2

    Randomization

    You will be randomly assigned to one of two treatment groups. One group will receive the new medication Sunvozertinib, and the other will receive a standard chemotherapy treatment.

  3. Step 3

    Treatment phase

    If you are in the Sunvozertinib group, you will take this medication orally in the form of a tablet. The dosage and frequency will be determined by the study team.

    If you are in the chemotherapy group, you will receive a combination of medications including Carboplatin and Pemetrexed. These will be administered through an infusion, which means the medication will be given directly into your bloodstream through a vein. The specific dosage and schedule will be provided by the study team.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, you will have regular visits to monitor your health and the effects of the treatment. This will include physical exams, blood tests, and imaging tests like CT or MRI scans.

    You will be asked to report any side effects or changes in your health to the study team.

  5. Step 5

    End of treatment

    Once the treatment phase is complete, you will have a final set of assessments to evaluate the overall impact of the treatment on your condition.

    You may be asked to continue with follow-up visits to monitor your health after the treatment has ended.

Who can join the trial?

12 criteria

  • Be able to understand the nature of the trial and provide a signed and dated, written informed consent form before any study-specific procedures.
  • Be at least 18 years old.
  • Have a confirmed diagnosis of non-squamous **Non-Small Cell Lung Cancer (NSCLC)** that is locally advanced or metastatic, which means the cancer has spread and is not suitable for curative therapy.
  • Have written documentation of an **EGFR Exon20ins mutation** in tumor tissue from a certified laboratory.
  • Have an adequate amount of archived tumor tissue or a fresh biopsy available for mutation confirmation and research purposes.
  • Have an **Eastern Cooperative Oncology Group (ECOG) performance status** of 0 or 1, indicating that you are fully active or have some symptoms but do not require bed rest.
  • If you have brain metastasis (cancer spread to the brain), it must be treated and stable, with no progression for at least 2 weeks after treatment, and you should not require steroid treatment.
  • Be newly diagnosed or have not received prior systemic treatment for locally advanced or metastatic NSCLC. Previous (neo)adjuvant therapy is allowed if it was given at least 6 months before the current diagnosis.
  • Have measurable disease according to specific criteria, meaning there is at least one tumor that can be accurately measured using imaging techniques like CT or MRI.
  • Have adequate blood and organ function as outlined in the study protocol.
  • Male participants with female partners of child-bearing potential should use barrier contraceptives, like condoms, during the study and for 6 months after the last dose of the study drug. They should also refrain from donating sperm during this time.
  • Females of child-bearing potential should use reliable contraceptives from the time of screening until 6 weeks after stopping the study treatment. They should not be breastfeeding and must have a negative pregnancy test before starting the study.

Who cannot join the trial?

9 criteria

  • Patients who have received previous treatment for their lung cancer.
  • Patients with other types of cancer that are not under control.
  • Patients with serious heart problems.
  • Patients with uncontrolled high blood pressure.
  • Patients with active infections that require treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients with known allergies to the study medication.
  • Patients with a history of severe allergic reactions.
  • Patients with any condition that the study doctors believe would make it unsafe to participate.
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Investigated drugs

  • DZD9008

    is a new medication being tested to see how well it works against a specific type of lung cancer. This type of lung cancer has a particular genetic change called the EGFR Exon 20 insertion mutation. The medication is designed to target and block the effects of this mutation, which may help stop the cancer from growing or spreading. Patients in the trial will receive this medication to see if it can effectively treat their cancer compared to other treatments.

  • Platinum-Based Doublet Chemotherapy

    is a standard treatment for certain types of lung cancer. It involves using two chemotherapy drugs together, one of which is a platinum-based drug. These drugs work by killing cancer cells or stopping them from growing. In this trial, this combination is used as a comparison to see if the new medication, DZD9008, is more effective in treating lung cancer with the EGFR Exon 20 insertion mutation.

What is already known about the treatment

DZD9008 – DZD9008 is administered orally in the form of tablets and is currently being studied in clinical trials as a potential treatment for a specific type of lung cancer known as non-small cell lung cancer (NSCLC) with a particular genetic mutation called EGFR Exon 20 insertion. This medication is being compared to standard chemotherapy to see if it works better in treating this cancer. DZD9008 works by targeting and blocking 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, which means it specifically aims at cancer cells with certain characteristics, potentially leading to fewer side effects compared to traditional chemotherapy.

Investigated diseases

Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation – This type of lung cancer is characterized by the presence of a specific genetic mutation in the epidermal growth factor receptor (EGFR) gene, known as the Exon 20 insertion mutation. It is a form of non-small cell lung cancer (NSCLC) that has either spread locally within the lung or to other parts of the body. The mutation leads to abnormal cell growth and division, contributing to cancer progression. As the disease advances, it can cause symptoms such as persistent cough, chest pain, and difficulty breathing. The progression of this cancer type is influenced by the mutation, which can affect how the cancer cells respond to certain treatments. Understanding the mutation is crucial for determining the most effective therapeutic approach.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502959-54-00Protocol codeDZD2022E0005Estimated enrolment344 patientsSponsorDizal Pharmaceutical Co. Ltd.

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