Active not recruitingPHASE3INTERVENTIONAL

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

This research study is for people in the UK with a type of lung cancer called small cell lung cancer (SCLC) that has returned after starting with platinum-based chemotherapy. If you are 18 or older and meet certain health requirements, you might be able to take part. The main goal is to compare a new medicine, Tarlatamab, with the usual chemotherapy options (Lurbinectedin, Topotecan, or Amrubicin) to see which one helps people live longer. This is a Phase 3 study, which means the new treatment has already shown some promise in earlier tests. By joining, you could help doctors learn more about better ways to treat SCLC.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Amgen

Enrolment target

509

Start

31 May 2023

Estimated completion

26 Mar 2028

Small Cell Lung Cancer (SCLC)

Results

Results from this study

Posted January 2026

Results have been published for this study.

Primary outcome

Overall Survival (OS)

OS was defined as time from randomization until death from any cause. Median overall survival was estimated using Kaplan-Meier method. 95% confidence intervals (CIs) were calculated using the Brookmeyer and Crowley method.

Full results on the registry

What is this study about?

This research study is looking for people in the UK who have small cell lung cancer (SCLC) that has come back or worsened after they've already had one type of chemotherapy treatment. SCLC is a specific kind of lung cancer that can be challenging to treat, especially if it returns.

The study aims to find out if a new medicine, called Tarlatamab, is more effective at helping people live longer compared to the standard chemotherapy treatments currently used. These standard treatments include medicines like Lurbinectedin, Topotecan, or Amrubicin. Essentially, doctors want to see if Tarlatamab offers a better outcome for patients in this situation. This is a very important step in developing new treatments.

By taking part in this study, you would be helping researchers understand more about SCLC and whether Tarlatamab could become a new, valuable treatment option for others in the future. All participants will receive either the new medicine or one of the standard treatments, and their health will be closely monitored by a medical team.

Key takeaways

Tests a new drug (Tarlatamab) for relapsed small cell lung cancer.
Compares Tarlatamab to standard chemotherapy options.
Aims to see which treatment helps people live longer.
For people aged 18+ whose cancer has returned after first chemotherapy.
Participation involves regular hospital visits, tests, and monitoring.
Your health will be closely supervised by a medical team.

Who may be eligible?

To join this study, you need to be at least 18 years old and have small cell lung cancer that has come back or progressed after your first chemotherapy treatment. Doctors will need to confirm your cancer and that it can be measured on scans.

You also need to be well enough to take part, meaning you can look after yourself and do light activities. Importantly, your body's main organs (like your heart, liver, and kidneys) need to be working properly. You shouldn't have certain other serious health problems, such as some severe heart conditions or uncontrolled infections, or another cancer that was diagnosed recently. Specific brain conditions also mean you can't join.

The study team will review your full medical history in detail to make sure this study is right and 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.

Are you 18 years old or older?
Do you have small cell lung cancer that has returned or progressed?
Have you had one previous platinum-based chemotherapy treatment?
Are you generally well and able to perform daily activities?
Do you have good organ function (heart, liver, kidneys, etc.)?
Do you not have certain other serious health conditions, such as uncontrolled infections or active severe autoimmune diseases?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to receive either the new medicine (Tarlatamab) or one of the standard chemotherapy options. Your treatment will be given on a regular schedule, and you'll have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is working.

The exact number of visits, tests, and the frequency will be clearly explained by the study team. You'll also be asked to provide your informed consent, which means you'll learn all about the study before you agree to participate. The total duration of your participation will depend on how you respond to the treatment and will be discussed with you.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new investigational treatment that might prove to be more effective than standard options, or closely monitored care by a specialist team. However, like all medicines, both the new treatment and standard chemotherapy can have side effects, which range from mild to serious, and these will be thoroughly explained to you. There's also no guarantee the treatment will work for you. You have the full right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (223)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of South Alabama Mitchell Cancer Institute
Verified postcode
Mobile, United States
Alaska Oncology and Hematology
Verified postcode
Anchorage, United States
University of Arkansas for Medical Sciences
Verified postcode
Little Rock, United States
University of California Los Angeles
Verified postcode
Santa Monica, United States
Northwestern University
Verified postcode
Chicago, United States
University of Illinois Chicago
Verified postcode
Chicago, United States
Indiana University
Verified postcode
Indianapolis, United States
University of Iowa
Verified postcode
Iowa City, United States
Pikeville Medical Center
Verified postcode
Pikeville, United States
Our Lady of the Lake Cancer Institute
Verified postcode
Baton Rouge, United States
Trinity Health Saint Joseph Mercy Ann Arbor
Verified postcode
Ann Arbor, United States
University of Minnesota Cancer Center
Verified postcode
Minneapolis, United States

Common questions

What is small cell lung cancer (SCLC)?

SCLC is a fast-growing type of lung cancer that often spreads quickly. This study is for people whose SCLC has returned after initial treatment.

What does 'relapsed' mean?

'Relapsed' means your cancer has come back or started to grow again after it was previously treated.

What is Tarlatamab?

Tarlatamab is a new medicine being tested in this study to see if it can help treat small cell lung cancer more effectively than current treatments.

Will I definitely get the new medicine?

No, you will be randomly assigned to either receive Tarlatamab or one of the standard chemotherapy treatments. It's like flipping a coin to decide.

Can I leave the study if I change my mind?

Absolutely. You can withdraw from the study at any point, for any reason, and it will not affect your regular medical care.