This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

A Trial to Evaluate DZD9008 as a Treatment for People with Non-Small Cell Lung Cancer with EGFR Gene Mutations

Trial ID: NCT03974022
This clinical trial is being done to learn about a possible treatment option for patients with non-small cell lung cancer (NSCLC). The investigational treatment being studied in this trial is called DZD9008. DZD9008 is called an “investigational treatment” because it is not approved for general use. Before an investigational treatment can be approved, it needs to be studied in clinical trials like this one so researchers and health authorities can understand how well it works and how safe it is. The trial will include adult participants from Argentina, Australia, Chile, France, Italy, Malaysia, South Korea, Spain, Taiwan, and the United States who have NSCLC and whose cancer cells have specific genetic mutations (changes in the cell’s genetic code). These mutations affect the way the cancer cells grow and divide, as well as the way a person’s cancer responds to treatment. The trial is currently enrolling people whose tumors have a genetic mutation known as an “EGFR exon 20 insertion.” Mutations like this are identified with genetic testing.

Trial Details

The main goals of this trial are to learn about:

  • The safety and tolerability of DZD9008 (the trial drug).
    • The trial doctors will look at any medical issues the participants have during treatment, including possible side effects of DZD9008.
  • The safest dose (or doses) of DZD9008 that should be studied further.
  • Whether each participant’s cancer responds to treatment with DZD9008.

The trial includes participants with advanced NSCLC whose tumors have “EGFR exon 20 insertion” mutations. The main goal of this part of the trial is to learn anti-tumor activity of DZD9008 anti-tumor activity in this patient population at defined dose(s). Researchers are currently looking for participants to join this part of the trial.

Estimated Enrollment

206 Participants



Eligibility Criteria

Participants must:

  • Be at least 18 years old.
  • Have a diagnosis of advanced or metastatic NSCLC. This is also known as Stage 3b or Stage 4 lung cancer, which means the cancer has spread to areas outside the lungs.
  • Have a tumor with a genetic mutation known as an “EGFR exon 20 insertion.” This is determined with a genetic test of the tumor cells. If you are interested in joining the trial but do not have these genetic testing results, this testing can be done after you agree to join.
  • Have received prior systemic treatment for advanced or metastatic NSCLC, such as chemotherapy or other anti-cancer drugs.
  • Be able to take medications by mouth.

Participants must not:

  • Have a medical history of pulmonary fibrosis (damage or scarring of the lung tissue) or bleeding disorders.
  • Have a recent history of stroke or brain bleeds (within the last 6 months).
  • Be pregnant or breastfeeding

Trial Site Locations

Sites are located in the cities/states identified with the red pin:

What Will Happen in This Trial

If you are interested in joining this trial, you will need to visit a clinical trial site. A doctor will explain the trial to you. If you agree to join, the doctors and other trial staff will ask you questions and run some medical tests to make sure you are eligible.

If you join the trial, you will receive treatment with DZD9008 until: - You decide to leave the trial, - Your cancer gets worse, - Your doctor thinks it would be in your best interest to stop treatment with DZD9008, OR - You are no longer willing or able to follow the trial rules and procedures.

While you are in the trial, you will visit your trial site regularly. During these visits, you will receive a new supply of your trial treatment. The trial staff will run tests and ask questions that help them keep track of your general health and understand what effect, if any, the trial treatment is having on your cancer.

Details about these visits and the types of tests that will be performed will be explained to you fully before you decide whether you want to join the trial.

Frequently Asked Questions (FAQs)