All studies
Active not recruitingPHASE3INTERVENTIONAL

Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab

This research study is for people in the UK aged 18 and over who have extensive-stage (advanced) small-cell lung cancer. All participants would have already completed 3 or 4 cycles of chemotherapy combined with durvalumab, and their cancer should not have worsened. The study aims to compare a new treatment combination, tarlatamab and durvalumab, against durvalumab on its own. The main goal is to find out if adding tarlatamab helps people live longer. This is a Phase 3 study, meaning these treatments have already been tested in earlier stages and are now being carefully compared to standard care to see if they offer a better outcome.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Amgen
Enrolment target
563
Start
05 Jun 2024
Estimated completion
30 Sep 2028

What is this study about?

This study is looking into new ways to treat extensive-stage small-cell lung cancer, which is a type of lung cancer that has spread. Doctors are always searching for better treatments, and this study focuses on what happens after a patient has finished their initial course of chemotherapy and a drug called durvalumab. Many people who have this type of cancer start with a combination of chemotherapy (using drugs like platinum and etoposide) and durvalumab. This study is for those whose cancer has responded well to this initial treatment, meaning it hasn't grown worse.

The main aim of this study is to see if adding a new medicine called tarlatamab to durvalumab can help people live longer than just continuing with durvalumab alone. Durvalumab is an immunotherapy drug that helps your own immune system fight cancer. Tarlatamab is also a type of immunotherapy. By comparing these two approaches, researchers hope to identify a more effective treatment strategy for people with advanced small-cell lung cancer.

This is a 'Phase 3' trial, which means the treatments have already shown promise in earlier studies, and now researchers are rigorously comparing them to established treatments. The results of studies like this are very important because they help doctors understand which treatments work best for patients. It's a careful step towards potentially improving care for people living with this challenging cancer.

Key takeaways

  • This study is for advanced small-cell lung cancer patients after initial chemotherapy.
  • It compares a new drug combination (tarlatamab + durvalumab) with durvalumab alone.
  • The main goal is to see if the new combination helps people live longer.
  • Participants must be 18+ and have responded well to their first round of treatment.
  • It's a Phase 3 trial, meaning treatments are carefully evaluated against current care.

Who may be eligible?

To be considered for this study, you would first need to sign a consent form, showing you understand and agree to take part. You must be at least 18 years old. A key requirement is that you have extensive-stage small-cell lung cancer and have recently finished 3 or 4 cycles of a specific chemotherapy (platinum-etoposide) along with durvalumab. Importantly, your cancer should not have progressed during this initial treatment, meaning it's either stable or has shrunk.

For your general health, you should be fairly active and able to look after yourself, with a good overall health score (doctors call this an 'ECOG performance status' of 0 or 1). Any side effects from your previous treatments, apart from hair loss or tiredness, should have largely gone away. Your body's organs, like your kidneys and liver, need to be working well. The study doctors would also need to confirm that your small-cell lung cancer is indeed extensive-stage.

Some things might mean you can't join. For example, if your cancer has spread to your brain and is causing symptoms, or if you've had certain serious reactions to immune-based treatments before. If you've had other cancers recently (unless they are very specific types) or have certain ongoing autoimmune conditions, you might also not be able to participate. The study also wouldn't be suitable if you've had a heart attack, serious heart failure, or a stroke within the last six months.

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 or older?
  2. Do you have extensive-stage small-cell lung cancer?
  3. Have you recently completed 3-4 cycles of platinum-etoposide chemotherapy plus durvalumab, and your cancer hasn't worsened?
  4. Are you generally active and able to look after yourself (ECOG 0 or 1)?
  5. Have any side effects from your previous treatment mostly cleared up (except hair loss/fatigue)?
  6. Are your major organs (like kidneys, liver) working well?
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 groups, like flipping a coin. One group would receive tarlatamab plus durvalumab, and the other would receive durvalumab alone. This is done to make sure the comparison between the treatments is fair. Both medicines are usually given through an IV drip.

You would have regular visits to the hospital for your treatment and to have tests done. These tests would include blood samples, scans (like CT scans) to check on your cancer, and physical examinations. These visits help the study team monitor how you are responding to the treatment and check for any side effects. The exact schedule of visits and tests would be clearly explained by the study team.

The treatment period would continue as long as the treatment is working for you and you are tolerating it well. After the treatment phase, you would continue to have follow-up appointments to monitor your health and the long-term effects of the treatment. The total duration of your involvement could vary depending on how you respond to the treatment, but the study team would keep you fully informed every step of the way.

Potential risks and benefits

Taking part in this study could potentially offer benefits, such as receiving a new combination treatment that might be more effective than existing options for extensive-stage small-cell lung cancer. All participants will receive careful medical monitoring and support from a dedicated study team. However, like all medications, the study drugs, tarlatamab and durvalumab, can cause side effects. These could range from mild, such as fatigue or skin reactions, to more serious ones that would be fully explained by the study team. There's also the chance that the treatment might not work for everyone, or could even make your condition worse. It's really important to remember that participating in a clinical trial is entirely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (219)

  • Infirmary Cancer Center
    Verified postcode
    Mobile, United States
  • University of Southern California
    Verified postcode
    Los Angeles, United States
  • Yale New Haven Hospital
    Verified postcode
    New Haven, United States
  • University Cancer and Blood Center LLC
    Verified postcode
    Athens, United States
  • Emory University
    Verified postcode
    Atlanta, United States
  • Northeast Georgia Medical Center
    Verified postcode
    Gainesville, United States
  • University of Illinois Chicago
    Verified postcode
    Chicago, United States
  • Franciscan Health Indianapolis
    Verified postcode
    Indianapolis, United States
  • Our Lady of the Lake Cancer Institute
    Verified postcode
    Baton Rouge, United States
  • Dana-Farber Cancer Institute
    Verified postcode
    Boston, United States
  • Cancer and Hematology Centers of Western Michigan
    Verified postcode
    Grand Rapids, United States
  • Mayo Clinic
    Verified postcode
    Rochester, United States

Common questions

What is small-cell lung cancer?

It's an aggressive type of lung cancer that often spreads quickly. 'Extensive-stage' means it has spread beyond the lung where it started.

What are tarlatamab and durvalumab?

They are both types of immunotherapy drugs. They work by helping your body's own immune system find and fight the cancer cells.

Why is this study being done?

Researchers want to see if combining tarlatamab with durvalumab helps people with advanced small-cell lung cancer live longer compared to durvalumab alone, after their initial treatment.

Will I get to choose which treatment I receive?

No, you would be randomly assigned to one of the two treatment groups, like drawing lots. This ensures the study is fair.

What happens if I want to stop being in the study?

You can leave the study at any time, for any reason. Your regular medical care will not be affected.

How to find out more

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

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