All studies
Active not recruitingPHASE3INTERVENTIONAL

Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer

This research study is looking at new treatment options for people with advanced non-small cell lung cancer that has spread to other parts of the body and hasn't been treated before. We're comparing two groups of treatments: one group will receive a combination of two new medicines, Zimberelimab and Domvanalimab, along with standard chemotherapy. The other group will receive an existing medicine called Pembrolizumab, also with standard chemotherapy. The main goal is to find out if the new combination helps people live longer compared to the standard treatment. The study is for adults over 18 and is designed to find the most effective way to help patients with this type of lung cancer.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Gilead Sciences
Enrolment target
1,021
Start
12 Oct 2022
Estimated completion
01 Jan 2029

What is this study about?

If you or someone you know has recently been diagnosed with advanced non-small cell lung cancer that has spread and hasn't had treatment yet, you might be interested in learning about this research study. Doctors are always looking for better ways to treat cancer, and this study aims to see if a new combination of medicines could be more effective than current treatments.

The study involves comparing two different treatment approaches. One approach uses a combination of two new investigational medicines, Zimberelimab and Domvanalimab, given with chemotherapy. The other approach uses an established medicine called Pembrolizumab, also given with chemotherapy. All these medicines are designed to work against cancer, but they do so in slightly different ways. The main thing the researchers want to find out is which combination helps people live longer.

This type of study, called a Phase 3 trial, is a very important step in developing new treatments. It means that the new medicines have already shown promise in earlier stages of testing. By carefully comparing these treatments, doctors hope to gain a clearer understanding of the best way to help people with this specific type of lung cancer.

Key takeaways

  • Tests new immunotherapy combinations with chemotherapy for advanced lung cancer.
  • Compares a new treatment to a standard one to see which is more effective.
  • For newly diagnosed, untreated metastatic non-small cell lung cancer.
  • Aims to find out if the new combination helps people live longer.
  • Involves regular hospital visits for treatments and check-ups.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with advanced non-small cell lung cancer that has spread to other parts of the body (Stage IV). Importantly, you should not have received any previous treatment for this advanced lung cancer. Doctors will also check that your cancer doesn't have certain genetic changes (like EGFR, ALK, ROS1, NTRK, BRAF, or RET mutations) that would mean a different standard treatment is available for you.

You should generally be in good health for someone with a cancer diagnosis, meaning you're able to carry out most daily activities without too much difficulty. Your doctors will also need to confirm that your body's organs, like your kidneys and liver, are working well enough to safely take part.

There are also some reasons why you might not be able to join. For example, if you've had a type of lung cancer called small-cell lung cancer mixed with non-small cell, or if you've recently had another type of cancer. Also, if you've previously received certain types of immunotherapy medicines, or if you have an active autoimmune disease that requires ongoing treatment, you wouldn't be able to participate. Pregnant or breastfeeding individuals cannot join either.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with advanced non-small cell lung cancer that has spread?
  3. Have you NOT received any prior treatment for your advanced lung cancer?
  4. Does your cancer NOT have specific genetic changes like EGFR or ALK mutations?
  5. Are you generally feeling well enough to do most daily activities?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the doctors and nurses will explain everything in detail. You would receive one of the two treatment combinations (either Zimberelimab and Domvanalimab with chemotherapy, or Pembrolizumab with chemotherapy). These medicines are typically given through a drip (intravenously) at scheduled visits to the hospital or clinic. The specific chemotherapy drugs used might include Carboplatin, Cisplatin, Paclitaxel, Nab-paclitaxel, or Pemetrexed.

Throughout the study, you would have regular appointments for check-ups, blood tests, and scans to monitor how you are doing and how the treatment is working. The study team would carefully watch for any side effects and manage them. The total duration of your participation would depend on how your body responds to the treatment, but these types of studies typically involve ongoing treatment and follow-up for a significant period. You would continue to receive treatment for as long as it is helping you and you are tolerating it well.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. You might benefit from receiving a new treatment combination that could be more effective than existing options, and you would receive very close medical monitoring throughout the study. However, there's no guarantee that the new treatments will work for you, and all medicines can have side effects, some of which could be serious or unexpected. The study team will explain all known potential side effects. Please remember that participating in a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (186)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Innovative Clinical Research Institute
    Verified postcode
    Whittier, United States
  • George Washington Medical Faculty Associates
    Verified postcode
    Washington D.C., United States
  • Moffitt Cancer Center
    Verified postcode
    Tampa, United States
  • Illinois Cancer Care
    Verified postcode
    Peoria, United States
  • Messino Cancer Centers
    Verified postcode
    Asheville, United States
  • Oncology Hematology Care, Inc.
    Verified postcode
    Cincinnati, United States
  • Hematology & Oncology Associates
    Verified postcode
    Eugene, United States
  • AHN Allegheny General Hospital
    Verified postcode
    Pittsburgh, United States
  • Texas Oncology - Austin
    Verified postcode
    Austin, United States
  • Oncology and Hematology Associates of Southwest Virginia, Inc
    Verified postcode
    Blacksburg, United States
  • Northwest Cancer Specialists, PC
    Verified postcode
    Vancouver, United States
  • Investigaciones CORI S.R.L.
    Unverified
    Capital, Argentina

Common questions

What is Non-Small Cell Lung Cancer (NSCLC)?

NSCLC is the most common type of lung cancer. 'Metastatic' means it has spread to other parts of the body.

What are Zimberelimab, Domvanalimab, and Pembrolizumab?

These are types of immunotherapy medicines. They work by helping your own immune system fight cancer cells. Chemotherapy uses strong drugs to kill cancer cells.

Why are they combining these drugs with chemotherapy?

Often, combining different types of treatments can be more effective against cancer than using just one, as they can attack the cancer in various ways.

What does 'untreated' mean in this study?

It means you haven't received any medicine, like chemotherapy or immunotherapy, specifically for your advanced lung cancer yet.

What is a 'Phase 3' study?

Phase 3 is a late stage of testing a new treatment. It compares the new treatment against existing ones to see if it's better or safer on a larger group of people.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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