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RecruitingPHASE3INTERVENTIONAL

Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients

This important study is comparing a new medication called ivonescimab with a widely used treatment, pembrolizumab, for people with non-small cell lung cancer that has spread. Both drugs will be given along with standard chemotherapy. The main goal is to find out if ivonescimab helps people live longer or stops their cancer from getting worse for a longer time compared to pembrolizumab. Researchers will also be checking how safe the treatments are and how well they shrink tumours. This is a large study, involving about 1,600 patients, to help improve future treatments for this type of cancer.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Summit Therapeutics
Enrolment target
1,600
Start
26 Oct 2023
Estimated completion
31 Dec 2029

What is this study about?

This study, called a Phase 3 trial, is a crucial step in testing new treatments. It's designed to compare two different ways of treating non-small cell lung cancer that has spread to other parts of the body (also known as metastatic lung cancer). One treatment involves a new drug called ivonescimab, given with standard chemotherapy. The other treatment is a drug called pembrolizumab, which is currently a common treatment, also given with chemotherapy.

Doctors want to see if ivonescimab works better than pembrolizumab in this situation. They will be carefully checking how long people live, how long it takes for the cancer to potentially grow or spread again, how safe the treatments are, and if the treatments help shrink tumours. By involving many patients across different hospitals, the study aims to get clear and reliable answers.

This kind of research is really important because it helps scientists and doctors understand which treatments are most effective and safest for people with advanced lung cancer. The results could lead to new and better treatment options available in the future for people with this condition.

Key takeaways

  • This study compares a new drug (ivonescimab) with a standard treatment (pembrolizumab) for widespread lung cancer.
  • Both treatments are given with chemotherapy.
  • It aims to find out if the new drug helps people live longer or stops cancer from growing for longer.
  • Participation involves regular hospital visits for treatment and check-ups.
  • You will be randomly assigned to one of two treatment groups, and neither you nor your doctor will know which one.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, you would need to be at least 18 years old and have a type of lung cancer called non-small cell lung cancer that has spread. Doctors would also check that you are generally well enough to take part and have a life expectancy of at least three months.

You would not be able to join if you have a different type of lung cancer called small cell lung cancer, or if your cancer has certain specific genetic changes (like EGFR, ALK, ROS1, and BRAF V600E) for which other approved treatments are already available. You also cannot have had any previous treatment for your widespread lung cancer, or if your tumour is growing in a way that significantly increases the risk of serious bleeding.

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. Do you have non-small cell lung cancer that has spread?
  3. Have you not had any previous treatment for your widespread lung cancer?
  4. Are your doctors happy that you are generally well enough to take part?
  5. Have tests shown your cancer does not have certain specific genetic changes (like EGFR, ALK, ROS1, or BRAF V600E)?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to one of two treatment groups – like flipping a coin, but done by a computer – to receive either ivonescimab or pembrolizumab, both combined with chemotherapy. Neither you nor your doctor would know which treatment you are receiving (this is called 'double-blind').

You would have regular hospital visits for your treatments and to have various tests and scans. These would include blood tests, physical examinations, and scans to see how the cancer is responding. These visits would continue for as long as you are receiving treatment. After finishing treatment, there would be follow-up appointments and tests to monitor your health and the cancer. The total length of your participation would depend on how your cancer responds to treatment.

Potential risks and benefits

Taking part in a clinical trial might offer the chance to try a new treatment that isn't yet widely available, which could potentially be more effective for your cancer. However, there's no guarantee the new treatment will work better than the standard one, and it might have different or unknown side effects. All treatments carry some risks, and doctors will carefully monitor you for any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (253)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Banner University Medical Center
    Verified postcode
    Phoenix, United States· Recruiting
  • TMC Healthcare
    Verified postcode
    Tucson, United States· Recruiting
  • Genesis Cancer and Blood Institute
    Verified postcode
    Hot Springs, United States· Recruiting
  • University of Arkansas
    Verified postcode
    Little Rock, United States· Recruiting
  • LA Cancer Network
    Verified postcode
    Anaheim, United States· Recruiting
  • The Oncology Institute of Hope & Innovation
    Verified postcode
    Cerritos, United States· Recruiting
  • University of Southern California (USC)
    Verified postcode
    Los Angeles, United States· Recruiting
  • Cedar Sinai Medical Center
    Verified postcode
    Los Angeles, United States· Recruiting
  • Valkyrie Clinical Trials
    Verified postcode
    Los Angeles, United States· Recruiting
  • Sutter Institute for Medical Research
    Verified postcode
    Sacramento, United States· Recruiting
  • UC Davis Medical Center
    Verified postcode
    Sacramento, United States· Recruiting
  • University of California Los Angeles (UCLA)
    Verified postcode
    Santa Monica, United States· Recruiting

Common questions

What is non-small cell lung cancer?

It's the most common type of lung cancer. This study is for people whose cancer has spread to other parts of the body.

What does a 'Phase 3' study mean?

It means it's a large, important study comparing a new treatment to a standard one to see which is better and safer.

What is 'chemotherapy'?

Chemotherapy is a type of medicine that kills cancer cells. In this study, it's given along with other drugs.

Will I know which treatment I'm getting?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know which of the two treatments you are receiving.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, and your medical care will not be affected.

How to find out more

Summit Clinical Trial Information

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

Interested in taking part?

Register your interest

Share your details and the research team for "Clinical Study of Ivonescimab for First-line Treatment of Me…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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