Active not recruitingPHASE1INTERVENTIONAL

Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)

This study is looking at a new treatment called tarlatamab for adults with small cell lung cancer (SCLC). Researchers want to understand how safe tarlatamab is, what side effects people might experience, and how the body handles the medicine. Tarlatamab will be given on its own, or with another treatment called pembrolizumab, and with strategies to help manage a specific side effect called cytokine release syndrome (CRS). This early-stage study (Phase 1) will give us important information about this new medicine for people whose SCLC has come back or is no longer responding to standard platinum-based treatments.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Amgen

Enrolment target

269

Start

26 Dec 2017

Estimated completion

31 Dec 2027

Small Cell Lung Carcinoma

What is this study about?

This study is exploring a new investigational medicine called tarlatamab for adults living with small cell lung cancer (SCLC). SCLC is a type of lung cancer that tends to grow quickly. The main goals of this early-stage study are to carefully check how safe tarlatamab is, how well people tolerate it (meaning, what side effects they experience), and how the medicine behaves in the body over time. This information is crucial for understanding if tarlatamab could be a helpful treatment in the future.

Tarlatamab is a special type of medicine designed to help your own immune system fight cancer. It's given as a short drip into a vein. In this study, tarlatamab might be given by itself, or together with another cancer medicine called pembrolizumab. The study is also looking at different ways to help manage a known side effect called 'cytokine release syndrome' (CRS), which can happen with this type of treatment.

By taking part in this study, volunteers will help doctors learn more about tarlatamab. This research could lead to new treatment options for people with SCLC, especially for those whose cancer has returned or progressed after previous standard treatments, like platinum-based chemotherapy.

Key takeaways

Exploring a new treatment (tarlatamab) for small cell lung cancer.
Testing safety, side effects, and how the body handles the medicine.
Specifically for cancer that has returned or not responded to previous treatments.
Involves intravenous (IV) infusions and close medical monitoring.
Aims to improve future treatment options for SCLC.

Who may be eligible?

To join this study, you must be at least 18 years old and have small cell lung cancer that has come back or not responded to previous platinum-based chemotherapy. Your doctors will also check that your general health and organ function are good enough for you to participate.

There are certain reasons why you might not be able to join. For example, if you've had other types of cancer recently, significant surgery very recently, or untreated or troublesome brain tumours. You also can't be on certain strong immune-suppressing medicines. The study team will review all your medical history carefully to make sure it's safe for you to take part.

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 or older?
Do you have small cell lung cancer that has come back or grown after other treatments?
Do you have generally good health, as assessed by your doctor?
Have you had major surgery more than 28 days ago?
Do you have stable brain tumours (if any) that are not causing symptoms?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have an initial screening visit to check if you're suitable. The study involves receiving tarlatamab, given as a short drip into a vein. Depending on which part of the study you are in, you might also receive pembrolizumab or specific treatments to prevent or manage side effects. You'll have regular visits to the clinic for assessments, blood tests, and to make sure you're tolerating the treatment well. The total duration of your participation will depend on how you respond to the treatment, though you will be monitored closely throughout the study and for a period afterwards.

Potential risks and benefits

Participating in this study might offer a potential benefit if tarlatamab helps control your cancer, or you could contribute to medical knowledge that benefits others in the future. However, there are potential risks, as tarlatamab is an investigational drug and may cause side effects, including cytokine release syndrome, which the study aims to manage. You will be closely monitored by medical staff for any reactions. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (39)

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

City of Hope National Medical Center
Verified postcode
Duarte, United States
Yale New Haven Hospital
Verified postcode
New Haven, United States
Moffitt Cancer Center
Verified postcode
Tampa, United States
Winship Cancer Institute
Verified postcode
Atlanta, United States
University of Chicago
Verified postcode
Chicago, United States
Ochsner Clinic Foundation
Verified postcode
New Orleans, United States
John Hopkins Sidney Kimmel Comprehensive Cancer Center
Verified postcode
Baltimore, United States
Henry Ford Health System
Verified postcode
Detroit, United States
Washington University
Verified postcode
St Louis, United States
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States
University Hospitals Cleveland Medical Center
Verified postcode
Cleveland, United States
The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic
Verified postcode
Columbus, United States

Common questions

What is small cell lung cancer?

Small cell lung cancer is a fast-growing type of cancer that usually starts in the lungs. It's often linked to smoking.

What is tarlatamab?

Tarlatamab is a new investigational medicine designed to help your immune system recognise and attack cancer cells.

What is 'cytokine release syndrome' (CRS)?

CRS is a possible side effect of certain immune-boosting treatments, which can cause symptoms like fever, fatigue, and muscle aches. The study has strategies to manage it.

Will I receive a placebo?

No, this study does not use a placebo. All participants will receive tarlatamab, either on its own or with other therapies.

How long will I be in the study?

The length of your participation will vary depending on your treatment response, but you will have regular clinic visits and follow-up care for an extended period.