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RecruitingPHASE3INTERVENTIONAL

A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)

This research study is for people with a type of advanced lung cancer called extensive stage small-cell lung cancer (ES-SCLC). Doctors are comparing two different treatment combinations. One combination includes a new drug called tarlatamab, given alongside durvalumab, carboplatin, and etoposide. The other combination, which is a standard treatment, includes durvalumab, carboplatin, and etoposide without tarlatamab. The main goal is to find out if adding tarlatamab helps patients live longer. This is a Phase 3 study, meaning it's one of the final steps to see if a new treatment is safe and effective before it can be widely available.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Amgen
Enrolment target
330
Start
18 Aug 2025
Estimated completion
15 Jul 2029

What is this study about?

This study is for people who have extensive stage small-cell lung cancer (ES-SCLC). This is a type of lung cancer that has spread beyond the lung where it started. Doctors are always looking for better ways to treat this aggressive cancer, and this study aims to see if a new treatment approach is more effective than current ones.

The study will compare two different treatment plans. One plan uses a combination of drugs that are already sometimes used for this type of cancer: durvalumab, carboplatin, and etoposide. The second treatment plan adds a new drug called tarlatamab to this existing combination. Tarlatamab works in a different way to target cancer cells.

The main aim of this study is to see if adding tarlatamab to the existing treatment helps people live longer. This is an important step in developing new medicines to help patients with ES-SCLC. By participating, you could help doctors learn more about the best ways to treat this condition in the future.

Key takeaways

  • This study compares a new drug combination with standard treatment for advanced small-cell lung cancer.
  • The main goal is to see if the new combination helps people live longer.
  • Participation involves regular clinic visits, treatments, and health monitoring.
  • You might receive the new drug (tarlatamab) or the standard treatment.
  • There are specific health criteria you must meet to be considered for the study.

Who may be eligible?

To join this study, you must be at least 18 years old and have a confirmed diagnosis of extensive stage small-cell lung cancer. Your cancer must be measurable, meaning doctors can track its size. Your doctors must also believe you are well enough to receive the treatments involved in the study, and you should be expected to live for at least 12 weeks.

There are also some reasons why you might not be able to join. For example, if you've had another type of cancer in the last two years, or if your lung cancer has spread to your brain causing symptoms. You also can't take part if you've had severe allergic reactions to similar treatments before, or if you've recently had a stroke or certain heart problems.

Other reasons that might prevent participation include having active autoimmune disease, certain infections like HIV or Hepatitis, serious lung conditions (like interstitial lung disease), or if you've had an organ transplant. The study team will carefully check all these points to ensure the study is safe for you.

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. I am at least 18 years old.
  2. I have been diagnosed with extensive stage small-cell lung cancer.
  3. My doctors think I am well enough to have these treatments.
  4. I haven't had another cancer diagnosed in the last two years.
  5. I don't have troublesome cancer spread to my brain or certain serious heart or lung conditions.
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of two treatment groups, like flipping a coin. You will receive either the standard treatment combination (durvalumab, carboplatin, and etoposide) or the new combination (adding tarlatamab to those three drugs). You will have regular visits to the clinic for your treatments, which are usually given through an IV (a drip into your arm).

During these visits, doctors and nurses will closely monitor your health, check for any side effects, and perform tests like blood tests and scans to see how you are responding to the treatment. The exact number and timing of visits, tests, and how long you receive treatment will be explained in detail by the study team. After your treatment period, you will have follow-up visits to continue monitoring your health and how you are doing in the long term. The total time you spend in the study, from your first dose to the final follow-up, can vary.

Potential risks and benefits

Taking part in a clinical trial might offer some potential benefits, such as access to a new drug (tarlatamab) that might be more effective than standard treatment for extensive stage small-cell lung cancer. You will also receive very close medical attention and monitoring. However, every treatment, especially new ones, comes with potential risks and side effects that are not fully known. You might experience side effects from the drugs, some of which could be serious. The study team will explain all known risks to you. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (157)

  • Cancer and Blood Specialists of Arizona
    Verified postcode
    Casa Grande, United States· Recruiting
  • City of Hope Cancer Center Phoenix
    Verified postcode
    Goodyear, United States· Recruiting
  • Saint Bernards Medical Center
    Verified postcode
    Jonesboro, United States· Recruiting
  • Translational Research in Oncology US Inc, Trio Central Pharmacy
    Verified postcode
    Los Angeles, United States· Recruiting
  • University of California Los Angeles
    Verified postcode
    Santa Monica, United States· Recruiting
  • Presbyterian Intercommunity Hospital Health Whitter Hospital
    Verified postcode
    Whittier, United States· Recruiting
  • Colorado West Healthcare System dba Grand Valley Oncology
    Verified postcode
    Grand Junction, United States· Recruiting
  • Yale New Haven Hospital
    Verified postcode
    New Haven, United States· Recruiting
  • Eastern Connecticut Hematology and Oncology Associates
    Verified postcode
    Norwich, United States· Recruiting
  • Cancer Specialists of North Florida - Southpoint
    Verified postcode
    Jacksonville, United States· Recruiting
  • Orlando Health Cancer Institute
    Verified postcode
    Kissimmee, United States· Recruiting
  • City of Hope Atlanta
    Verified postcode
    Newnan, United States· Recruiting

Common questions

What is extensive stage small-cell lung cancer?

This is a type of lung cancer that has spread from where it started to other parts of the body.

What is tarlatamab?

Tarlatamab is a new investigational drug being tested in this study, which aims to help the body's immune system fight cancer.

Will I definitely get the new drug?

No, you will be randomly assigned to one of two groups: one gets the new drug added to standard treatment, and the other gets standard treatment only.

How long will I be in the study?

This can vary for each person, depending on how long they receive treatment and how long they need follow-up appointments.

Can I stop being in the study if I change my mind?

Yes, you can choose to leave the study at any time, and it will not affect your medical care.

How to find out more

Amgen Call Center

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 "A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and E…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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