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

Phase

2

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)

Will there be any costs or compensation for participating in this trial?

There will be no cost to you or your insurance company for taking part in the study. You may have some expenses from being in the study, such as travel costs (bus fare or parking fees) and lodging when you visit the study center and these expenses may be paid back. Please ask someone from the study staff for more information.

What is a clinical trial?

Through clinical research, scientists and doctors can determine whether a new medical strategy, drug, or device is safe and effective for people. New treatments cannot be discovered without clinical trials, which rely on potential trial participants like you to evaluate the safety and effectiveness of these treatments.

Clinical trials follow a research plan, also called a protocol, which is created before the trial starts. The protocol describes what treatments the participants will receive, what questions the researchers will try to answer, how long the trial will last, and how participant privacy and safety will be protected during the trial. Before you decide to join a clinical trial, the trial team will explain all of these trial details.

Participation in a clinical trial is voluntary. Trial participants should have the intention to complete the trial, but they may leave the trial at any time after they join.

What is a Phase 2 clinical trial?

When new drugs are being studied as a possible treatment for patients with a disease, they are tested in stages, or “phases.” If a drug is successful in Phase 1, it moves to Phase 2. If it is successful in Phase 2, it moves to Phase 3.

Researchers may conduct a Phase 1 trial to learn more about how a drug (or drug combination) behaves in the body, to find a safe dose, or to test a new formulation of a drug (such as a pill versus an injection). Phase 1 studies are usually conducted with a small number of participants.

In a Phase 2 trial, a drug is studied in a larger group. Researchers conduct Phase 2 trials to study how well a drug works and to learn more about the safety and tolerability of a drug, including any side effects people might have when they take it.

Will I automatically be accepted into this clinical trial?

No, not until there are additional checks to your recent medical tests and medical history to make sure that you can safely join this trial. Every trial has detailed requirements for enrollment. These are called the eligibility criteria.

How can I check to see if I’m eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this website by clicking the “Prescreen Now” or “Get Started” buttons.

Can I quit the trial at any time?

Trial participants have the right to drop out of the trial at any time for any reason or no reason at all. The trial doctor or sponsor also has the right to discontinue a trial participant at any time for the participant’s safety or if the participant no longer meets the trial requirements.

What personal information is collected about me for the trial?

The trial doctor and other trial staff will collect your personal information. This may include: - Your name, address, telephone number, and health insurance number, where applicable - Your age, sex, and ethnic and racial background - Your lifestyle information - Your medical history details - Your trial treatment and your response to this treatment - Data resulting from testing your biological samples

Who has access to my personal information?

All personal information collected for this trial will be securely stored in the trial medical records at the clinical trial site. Sponsor staff, review boards, ethics committees (that approve and monitor studies), and others who have a need to know, such as our data hosting provider and government regulators, may check trial records. Regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and others, review and approve new medicines. These agencies will be granted direct access to your information. This is so they can verify trial procedures and/or data. If you share your personal data with a clinical trial site, that data will be used by Citeline Connect to contact you about clinical studies and related information.

This trial is not actively recruiting.