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Study Comparing Zimberelimab and Domvanalimab with Chemotherapy to Pembrolizumab with Chemotherapy for Patients with Untreated Metastatic Non-Small Cell Lung Cancer

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 treatments for Metastatic Non-Small Cell Lung Cancer, a type of lung cancer that has spread to other parts of the body. The study will compare two different treatment combinations. One group will receive a combination of two medications, Zimberelimab and Domvanalimab, along with chemotherapy. The other group will receive Pembrolizumab with chemotherapy. Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells.

The purpose of the study is to compare the effects of these two treatment combinations. Participants will be randomly assigned to one of the two groups. The study will involve regular visits to the clinic for treatment and monitoring. Treatments will be given through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will continue for a period of time, during which participants will receive their assigned treatments and undergo various assessments to monitor their health and the progress of the cancer.

Throughout the study, participants will be closely monitored by healthcare professionals. The study aims to determine which treatment combination is more effective in managing the cancer and improving the overall survival of patients. Participants will also be monitored for any side effects or changes in their condition. The information gathered from this study will help in understanding the best treatment options for patients with Metastatic Non-Small Cell Lung Cancer.

The research process

The trial runs in 6 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 participant will be randomly assigned to one of two groups. Each group will receive a different combination of treatments for metastatic non-small cell lung cancer.

  2. Step 2

    Treatment group assignment

    Group A will receive a combination of zimberelimab and domvanalimab with chemotherapy. Group B will receive pembrolizumab with chemotherapy.

    All medications will be administered through an intravenous infusion, which means they will be given directly into a vein.

  3. Step 3

    Chemotherapy regimen

    The chemotherapy drugs used in the study may include cisplatin, pemetrexed, carboplatin, paclitaxel, and paclitaxel albumin-bound. The specific drugs and their dosages will depend on the participant's assigned group and individual treatment plan.

  4. Step 4

    Treatment duration

    The treatment will continue as long as it is effective and the participant can tolerate it. The study aims to evaluate the progression-free survival and overall survival of participants.

  5. Step 5

    Monitoring and assessments

    Participants will undergo regular monitoring and assessments to evaluate the effectiveness of the treatment and to check for any side effects. This includes imaging tests to measure tumor size and blood tests to monitor health.

  6. Step 6

    End of treatment

    The treatment will end if the disease progresses, if the participant experiences unacceptable side effects, or if the study reaches its conclusion. The estimated end date for the study is September 30, 2027.

Who can join the trial?

12 criteria

  • People of all genders, races, and ethnic groups can join the study.
  • Participants who can have children and engage in heterosexual intercourse must agree to use specific birth control methods during the study and for a certain time after the last dose of treatment.
  • Participants must be willing and able to follow the study's rules and restrictions.
  • Participants must be 18 years or older and able to understand and sign a consent form.
  • Participants should have a life expectancy of at least 3 months.
  • Participants must have a confirmed diagnosis of **Stage IV Non-Small Cell Lung Cancer (NSCLC)**, which is a type of lung cancer that has spread to other parts of the body.
  • Participants must have negative test results for **EGFR** and **ALK** mutations, which are specific changes in cancer cells.
  • Participants should not have certain genetic changes, like **ROS1**, **NTRK**, **BRAF**, or **RET** mutations, that have approved treatments.
  • Participants must provide a sample of their tumor tissue that has not been treated with radiation before, to check for **PD-L1** expression, which is a protein related to cancer growth.
  • Participants should not have received previous treatment for metastatic NSCLC. If they had chemotherapy for nonmetastatic disease, it must have been completed at least 12 months before starting the study treatment.
  • Participants must have measurable disease according to specific criteria, meaning the cancer can be measured and tracked.
  • Participants must have an **ECOG performance status** score of 0 or 1, which indicates they are fully active or have some symptoms but can still carry out light work.

Who cannot join the trial?

7 criteria

  • Patients with other types of cancer besides Metastatic Non-Small Cell Lung Cancer cannot participate. This type of cancer has spread from the lungs to other parts of the body.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not able to follow the study procedures or who have conditions that might interfere with the study results cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate, as the study may involve risks to the baby.
  • Patients who have participated in another clinical trial recently may not be eligible to participate in this study.
  • Patients with certain medical conditions that could affect the study's outcome or their safety may not be eligible.
  • Patients who are unable to provide informed consent, which means they cannot understand the study and agree to participate, cannot be included.
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Investigated drugs

  • Zimberelimab

    is a medication used in this trial to help the body's immune system fight cancer cells. It works by blocking a specific protein that can stop the immune system from attacking cancer cells, allowing the immune system to better target and destroy them.

  • Domvanalimab

    is another medication in the trial that is used alongside Zimberelimab. It also helps the immune system by targeting a different protein, which can enhance the immune response against cancer cells, making the treatment more effective.

  • Pembrolizumab

    is a medication that helps the immune system recognize and attack cancer cells. It works by blocking a protein that prevents the immune system from attacking the cancer, thereby boosting the body's natural defenses to fight the cancer.

  • Chemotherapy

    refers to the use of drugs to kill or slow the growth of cancer cells. In this trial, chemotherapy is used in combination with the other medications to enhance the overall effectiveness of the treatment against lung cancer.

What is already known about the treatment

  • Zimberelimab

    Zimberelimab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating metastatic non-small cell lung cancer. It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication for Zimberelimab is as a first-line treatment for patients with this type of lung cancer, particularly those without specific genetic mutations. It works by targeting and inhibiting certain proteins on immune cells, enhancing the body's immune response against cancer cells. Zimberelimab is classified as an immune checkpoint inhibitor.

  • Domvanalimab

    Domvanalimab is given through intravenous infusion and is being evaluated in clinical trials for its potential to treat metastatic non-small cell lung cancer. It is not yet approved for general medical use, as research is ongoing. The primary therapeutic use of Domvanalimab is in combination with other treatments for lung cancer patients lacking certain genetic alterations. It functions by blocking specific immune checkpoints, thereby boosting the immune system's ability to attack cancer cells. Domvanalimab falls under the category of immune checkpoint inhibitors.

  • Pembrolizumab

    Pembrolizumab is administered via intravenous infusion and is an established medication used in the treatment of various cancers, including metastatic non-small cell lung cancer. It is widely recognized in medical literature and practice. The main therapeutic indication for Pembrolizumab is as a first-line treatment for this type of lung cancer, especially in patients without certain genetic mutations. It works by inhibiting a protein that restricts the immune system, thus allowing the body to better target and destroy cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor.

Investigated diseases

Metastatic Non-Small Cell Lung Cancer – This is a type of lung cancer that begins in the cells of the lungs and has spread to other parts of the body. It is the most common form of lung cancer, accounting for about 85% of cases. The disease progresses as cancer cells grow and form tumors in the lungs, which can then metastasize to other organs such as the brain, bones, or liver. Symptoms may include persistent cough, chest pain, shortness of breath, and unexplained weight loss. As the cancer spreads, it can cause additional symptoms depending on the organs affected. The progression of the disease can vary greatly among individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509825-38-00Protocol codeGS-US-626-6216Estimated enrolment720 patientsSponsorGilead Sciences Inc.

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