Active not recruitingPHASE2INTERVENTIONAL

A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)

This study is looking at a new treatment called tarlatamab for people in the UK aged 18 and over who have Small Cell Lung Cancer (SCLC). This is a cancer that has either returned after being treated, or hasn't responded to previous treatments like platinum-based chemotherapy. The main goal is to understand how safe tarlatamab is and how well it works to shrink or control the cancer. Researchers will test different amounts of the medicine and closely monitor participants. If you or someone you know has SCLC and fits these descriptions, this study might be a possibility to discuss with your doctor.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Amgen

Enrolment target

222

Start

01 Dec 2021

Estimated completion

30 Dec 2027

Relapsed/Refractory Small Cell Lung Cancer

What is this study about?

This research study is focused on Small Cell Lung Cancer (SCLC), a type of lung cancer. Unfortunately, SCLC often comes back or doesn't respond well to standard treatments. This study is testing a new medicine called tarlatamab. The main idea behind this research is to find more effective and safer ways to treat SCLC for people who haven't had success with earlier treatments.

Researchers want to learn two main things about tarlatamab: how safe it is for people to take, and how well it works to help patients. They will be watching to see if the medicine can stop the cancer from growing or even make it shrink. This is important work because it could lead to new treatment options for people living with SCLC.

By taking part, you would be helping doctors understand if tarlatamab could become a new standard treatment in the future. Studies like this are vital for bringing new medicines to people who need them most.

Key takeaways

This study is for people with Small Cell Lung Cancer (SCLC) that has returned or not responded to previous treatments.
It's testing a new medicine called tarlatamab to see if it's safe and effective.
Participation involves regular hospital visits, tests, and receiving the study drug.
You can leave the study at any time without affecting your normal medical care.

Who may be eligible?

To join this study, you must be 18 years old or older and have Small Cell Lung Cancer (SCLC) that has either returned or hasn't responded to at least two previous treatments, one of which must have been a platinum-based chemotherapy. You'll also need to be able to provide a sample of your cancer tissue, or agree to have a small biopsy. Doctors will also check your general health to make sure you're well enough for the study, for example, your ability to do daily activities.

There are also some reasons why you might not be able to join. For example, if your cancer has spread to your brain and is causing symptoms, or if you've recently had severe lung or heart problems. They will also check if you have certain other serious health conditions or infections that could make it unsafe for you to take part. All these checks are to ensure your safety throughout the study.

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 (SCLC) that has returned or grown despite previous treatments?
Are you able to provide a tissue sample of your cancer, or have a small biopsy if needed?
Are you generally well enough to manage daily activities without too much difficulty?
Do you have any current uncontrolled infections or untreated symptomatic brain metastases?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the first step is to read and understand all the information, and then sign a consent form. This tells us you agree to participate. You'll have regular hospital visits for check-ups, blood tests, and scans to see how you're responding to the medicine. The study drug, tarlatamab, will be given to you at the hospital. Doctors and nurses will explain how often you'll receive it.

Throughout the study, the medical team will monitor you closely for any side effects or changes in your health. You may need extra tests or visits if anything needs to be checked. We don't have a fixed total duration for each individual's participation, as it depends on how you respond to the treatment and your health. However, there will be follow-up appointments even after you stop taking the study drug to continue monitoring your health.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. One potential benefit is that you might receive a new treatment, tarlatamab, which could help your cancer when other treatments haven't worked. However, there's no guarantee it will work for everyone, and it might not work better than existing treatments. Potential risks include experiencing side effects from the medication, which will be carefully monitored by the study team. You will be given detailed information about these potential side effects. It's very 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 (80)

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

University of Alabama at Birmingham
Verified postcode
Birmingham, United States
University of Arkansas for Medical Sciences
Verified postcode
Little Rock, United States
Christiana Care Health Services
Verified postcode
Newark, United States
Moffitt Cancer Center
Verified postcode
Tampa, United States
Winship Cancer Institute
Verified postcode
Atlanta, United States
University of Iowa
Verified postcode
Iowa City, United States
Dana Farber - Harvard Cancer Center
Verified postcode
Boston, United States
Henry Ford Health System
Verified postcode
Detroit, United States
Dartmouth Hitchcock Medical Center
Verified postcode
Hanover, United States
Duke University Medical Center
Verified postcode
Durham, United States
Wake Forest Baptist Comprehensive Cancer Research Center
Verified postcode
Winston-Salem, United States
Oncology Hematology Care Inc
Verified postcode
Cincinnati, United States

Common questions

What is Small Cell Lung Cancer (SCLC)?

SCLC is a fast-growing type of lung cancer. It often spreads quickly, but it also tends to respond well to chemotherapy and radiation therapy initially.

What does 'relapsed/refractory' mean?

Relapsed means your cancer came back after treatment. Refractory means your cancer did not respond to treatment or got worse during treatment.

What is tarlatamab?

Tarlatamab is a new medicine being tested in this study. It's designed to target cancer cells in a particular way.

Will I get a placebo (dummy drug)?

No, this study does not involve a placebo. Everyone taking part will receive tarlatamab at one of two dose levels.

How long will I be in the study?

The length of time you participate can vary. You will continue to receive the study drug as long as it is helping you and you are not experiencing significant side effects.