Active not recruitingPHASE2INTERVENTIONAL

A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With SCLC

This research study is investigating a new medication called tarlatamab for people diagnosed with small cell lung cancer (SCLC). The main goal is to understand how effective tarlatamab is at treating this type of cancer and to learn more about its safety. Participants in the study will have SCLC that has either come back or gotten worse after they've already had at least one common type of chemotherapy that includes platinum. Researchers want to see if tarlatamab can help shrink tumours or stop the cancer from growing. This is a Phase 2 study, which means it’s an important step in determining if the treatment could be helpful in the future.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Amgen

Enrolment target

252

Start

26 Feb 2025

Estimated completion

09 Feb 2029

Small Cell Lung Cancer (SCLC)

What is this study about?

This research study is looking at a new medicine called tarlatamab for people who have a type of lung cancer called small cell lung cancer (SCLC). This particular study aims to find out how well tarlatamab works against SCLC and to make sure it's safe for patients. We know that small cell lung cancer can be challenging to treat, especially when it comes back or gets worse after initial treatments. That's why doctors are always searching for new options.

In this study, individuals will be given tarlatamab to see if it can help control their cancer. The doctors will carefully watch how participants respond to the treatment, looking for signs that the cancer is shrinking or stopping its growth. They will also be keeping a close eye on any side effects to understand the medicine's safety profile. This is considered a 'Phase 2' study, which means it’s a crucial step in testing new medicines before they can become widely available.

Taking part in a study like this helps doctors learn more about new ways to fight cancer. The information gathered from participants can lead to better treatments for future patients with SCLC. It's a way for individuals to potentially get access to a new treatment while also contributing to medical science.

Key takeaways

This study is testing a new drug, tarlatamab, for small cell lung cancer.
It's for people whose cancer has progressed after previous chemotherapy.
The main goals are to check how well it works and its safety.
Participation involves regular clinic visits, tests, and receiving the study drug.
You can stop participating at any time.
This research helps find new treatments for SCLC.

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 been confirmed by a doctor. Your cancer must have either come back or grown worse after you've had at least one type of chemotherapy that included a platinum-based medicine. The doctors will also need to be able to measure your cancer on scans and you should generally feel well enough to take part, as assessed by a doctor.

There are also some reasons why you might not be able to join. For example, if you have certain other serious medical conditions like uncontrolled heart problems, severe lung disease, or certain active infections. If you've had other cancers recently, or if your cancer has spread to your brain causing symptoms, you might not be suitable. The study team will review all of your health information carefully to see if this study is right 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?
Has your cancer come back or gotten worse after receiving platinum-based chemotherapy?
Do you feel well enough to be active for most of the day?
Are your other organs (like your liver and kidneys) working well?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first have to agree in writing after understanding all the details. You will receive the study medication, tarlatamab, which is given as an infusion (into your vein). The study will involve regular visits to the clinic for check-ups, blood tests, and scans to see how your body is responding to the treatment and to keep an eye on your cancer. These visits will also help doctors monitor for any side effects.

The specific number of visits and tests will be explained to you by the study team, and it's designed to make sure your health is closely monitored throughout the study. The total length of your participation is not fixed here but will depend on how your cancer responds and how you tolerate the treatment. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as access to a new treatment (tarlatamab) for small cell lung cancer that is not yet widely available. This treatment might help to shrink your cancer or slow its growth. However, like all medicines, tarlatamab can have side effects, which could range from mild to serious. The study team will explain all known side effects and monitor you closely for any issues that arise. There's also no guarantee that the treatment will be effective for everyone. You have the right to leave the study at any time, for any reason, and this decision will not affect your future medical care.

Locations (78)

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

University of California Los Angeles
Verified postcode
Los Angeles, United States
Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut
Verified postcode
Plainville, United States
AdventHealth Hematology and Oncology
Verified postcode
Orlando, United States
City of Hope Chicago
Verified postcode
Rockford, United States
Health Partners Cancer Center at Regions Hospital
Verified postcode
Saint Paul, United States
New York Oncology Hematology PC
Verified postcode
Albany, United States
Duke University
Verified postcode
Durham, United States
FirstHealth Cancer Center
Verified postcode
Pinehurst, United States
Guthrie Medical Group
Verified postcode
Sayre, United States
Tennessee Oncology PLLC - Chattanooga
Verified postcode
Chattanooga, United States
Tennessee Oncology, PLLC
Verified postcode
Nashville, United States
Virginia Cancer Specialists PC
Verified postcode
Fairfax, United States

Common questions

What is tarlatamab?

Tarlatamab is a new medicine being tested for small cell lung cancer. It works by targeting cancer cells in a specific way.

Who can take part in this study?

Adults (18+) with small cell lung cancer that has progressed after at least one previous platinum-based chemotherapy regimen, and who meet other health criteria.

Will I know if I'm getting the actual study drug?

Yes, this is an 'open-label' study, meaning everyone participating will receive tarlatamab, the medicine being tested.

What does 'Phase 2' mean for a clinical trial?

Phase 2 means the study is focused on seeing if the new medicine works and how safe it is for a larger group of people, after earlier tests suggested it might be helpful.

What if I experience side effects?

The study team will monitor you very closely for any side effects, and they will provide care and advice on how to manage them.