Active not recruitingPHASE3INTERVENTIONAL

Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)

This research study is investigating a new medication called Tarlatamab for patients who have limited-stage small-cell lung cancer (LS-SCLC). This is a type of lung cancer that has been treated with chemotherapy and radiotherapy. The main goal of the study is to find out if Tarlatamab can prevent the cancer from growing or spreading for a longer time compared to a placebo (a dummy drug). Researchers also want to see if Tarlatamab helps people live longer overall. The study is in its final phase (Phase 3), meaning it's being tested on a larger group of people to confirm its effectiveness and safety. Participants will be carefully monitored throughout the study to track their progress and any potential side effects.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Amgen

Enrolment target

404

Start

20 Feb 2024

Estimated completion

20 Apr 2030

Limited Stage Small Cell Lung Cancer Small Cell Lung Cancer

What is this study about?

This study is for adults who have limited-stage small-cell lung cancer (LS-SCLC). This is a type of lung cancer that, when diagnosed, is usually found to be in one side of the chest. Patients in this study would have already had standard treatment, which typically involves chemotherapy and radiotherapy, and their cancer should not have got worse after these treatments.

The main aim is to see if a new drug, Tarlatamab, can help these patients. Researchers want to find out if Tarlatamab stops the cancer from growing or spreading for a longer time than a placebo (an inactive substance that looks just like the real drug). They also want to see if it helps people live longer overall. The study will carefully compare the group receiving Tarlatamab with the group receiving the placebo to understand the drug's effects. Everyone will be closely monitored by medical professionals.

This is an important step in finding new ways to treat this type of lung cancer. By comparing Tarlatamab to a placebo, doctors can get a clear picture of whether this new drug is effective and safe. The results of studies like this help improve future cancer treatments and offer more options for patients.

Key takeaways

This study evaluates a new drug, Tarlatamab, for limited-stage small-cell lung cancer.
It's for people who have already completed chemotherapy and radiotherapy.
The main goals are to see if Tarlatamab can stop cancer from progressing longer and improve overall survival.
Participants will receive either Tarlatamab or a placebo.
Regular health checks and scans will be part of the study.
Participation contributes to understanding new cancer treatments.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of limited-stage small-cell lung cancer. You must have already completed your treatment with chemotherapy and radiotherapy, and your cancer should not have become worse since then. You also need to be generally well enough to take part, with a good level of energy and your body's organs working properly. Any side effects from your chemoradiotherapy should have mostly cleared up.

There are also some reasons why you might not be able to join. For example, if your cancer has spread beyond the limited stage, or if you have certain other serious medical conditions like specific heart problems, or a history of other cancers within the last two years. The study also excludes people with certain lung conditions or infections.

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 at least 18 years old?
Do you have limited-stage small-cell lung cancer?
Have you finished your chemotherapy and radiotherapy for SCLC, and your cancer hasn't gotten worse?
Are you generally feeling well with a good energy level?
Have any side effects from your previous treatments mostly cleared up?
Do you not have certain other serious health conditions, as explained by your doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new drug, Tarlatamab, or a placebo (a dummy drug). You wouldn't know which one you're getting, nor would your study doctor. This is done to ensure the results are fair. You'll have regular hospital visits for check-ups, blood tests, and scans to see how you're responding to the treatment and to monitor your health. These visits will also be used to give you your study medication.

The specific schedule of visits and tests will be explained in detail by the study team. You'll continue to receive the study treatment as long as it's helping you and you're not experiencing serious side effects. After treatment, there will be follow-up appointments to keep track of your long-term health. The total time you'd be involved in the study, including follow-up, could be several years.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. You might benefit from the new drug if it proves to be effective, or you might find comfort in contributing to medical research that could help others. However, there's no guarantee that the drug will work for you, and like all medications, Tarlatamab may have side effects, which could be mild or severe. The study team will carefully monitor you for any side effects. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (204)

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

Valkyrie Clinical Trials
Verified postcode
Los Angeles, United States
University of California Los Angeles
Verified postcode
Santa Monica, United States
Yale New Haven Hospital
Verified postcode
New Haven, United States
Boca Raton Clinical Research Global South Florida
Verified postcode
Plantation, United States
University of Louisville James Graham Brown Cancer Center
Verified postcode
Louisville, United States
Our Lady of the Lake Cancer Institute
Verified postcode
Baton Rouge, United States
Morristown Medical Center
Verified postcode
Morristown, United States
New York University Grossman School of Medicine and New York University Langone Hospitals
Verified postcode
New York, United States
Perlmutter Cancer Center at New York University Langone Hospital - Long Island
Verified postcode
New York, United States
Montefiore Einstein Center for Cancer Care
Verified postcode
The Bronx, United States
FirstHealth Cancer Center
Verified postcode
Pinehurst, United States
Lehigh Valley Health Network
Verified postcode
Allentown, United States

Common questions

What is small-cell lung cancer (SCLC)?

SCLC is a type of lung cancer that can grow and spread quickly. Limited-stage means it's usually found in one side of the chest.

What is Tarlatamab?

Tarlatamab is a new investigational drug being tested to see if it can help treat limited-stage small-cell lung cancer after initial treatments.

What is a placebo?

A placebo is a substance that looks exactly like the study drug but contains no active medication. It's used to fairly compare the new drug's effects.

Will I know if I'm getting the drug or the placebo?

No, neither you nor your study doctor will know whether you are receiving Tarlatamab or the placebo. This is to ensure unbiased results.

What does 'progression-free survival' mean?

It means the length of time a person lives with the disease without it getting worse or spreading.