Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab

This study is looking into a new treatment for a serious type of lung cancer called Extensive Stage Small Cell Lung Cancer (ES-SCLC). The new treatment combines a special radioactive medicine, [177Lu]Lu-DOTA-TATE, with standard chemotherapy (carboplatin and etoposide) and another anti-cancer drug (atezolizumab). Researchers want to find the safest dose of this new combination and then see if it works better at fighting the cancer than the standard chemotherapy and atezolizumab alone. This is an important step to find new and potentially more effective ways to treat this aggressive cancer in people who have recently been diagnosed.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Novartis Pharmaceuticals

Enrolment target

Start

13 Jul 2022

Estimated completion

23 Mar 2029

Extensive Stage Small Cell Lung Cancer

What is this study about?

This study is investigating a new treatment approach for Extensive Stage Small Cell Lung Cancer (ES-SCLC). This is a fast-growing type of lung cancer, and doctors are always looking for better ways to treat it. The new treatment involves a special type of medicine called [177Lu]Lu-DOTA-TATE, which is a radioactive drug designed to target cancer cells. This drug will be given alongside atezolizumab and a standard chemotherapy combination of carboplatin and etoposide.

The main goals of this research are twofold. First, the study needs to find the safest and most tolerable dose of this new combination treatment. This is very important to make sure patients can receive the treatment without too many side effects. Second, once a safe dose is found, the study will compare this new combination directly to the current standard treatment (carboplatin, etoposide, and atezolizumab) to see if it is more effective at treating the cancer. The hope is that this new combination could offer a better way to fight this aggressive cancer.

Taking part in this study could offer you access to a new treatment that isn't widely available yet. It's a key step in understanding if this new approach can improve the lives of people with ES-SCLC. The study is designed to carefully monitor participants and gather information to help future patients.

Key takeaways

Tests a new combination treatment for ES-SCLC.
Aims to find a safe dose and improve cancer outcomes.
Compares a new drug with standard chemotherapy and immunotherapy.
Involves a screening, treatment, and follow-up period.
Participation is voluntary and you can withdraw anytime.

Who may be eligible?

To join this study, you must be at least 18 years old and have been diagnosed with Extensive Stage Small Cell Lung Cancer (ES-SCLC). Your cancer should be 'measurable,' meaning doctors can see and track it, and you shouldn't have had previous treatments for ES-SCLC, apart from possibly your very first round of chemotherapy. Your general health, as assessed by a doctor, should be good enough to take part, and you should be expected to live for at least six more months.

There are also some reasons why you might not be able to join. For example, if you've already had certain types of anti-cancer treatments that affect your immune system, or if you have serious ongoing infections like tuberculosis, hepatitis B, or hepatitis C. Also, if you have certain heart problems, severe autoimmune diseases, or allergies to any of the study medications, you wouldn't be able to participate. You also shouldn't be involved in another medical study at the same time.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of Extensive Stage Small Cell Lung Cancer?
Have you had very little or no previous treatment for your ES-SCLC?
Are you generally well enough to take part in a study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, the study will involve several stages. First, there's a screening period of up to 28 days to check if the treatment is right for you, including a special scan to look at your cancer. Then, you'll enter the treatment period, which has two parts: an 'Induction' phase followed by a 'Maintenance' phase. During the early part of the study, different groups of participants will receive different doses of the new treatment to find the safest level. Once a safe dose is found, about 140 participants will be randomly assigned to either receive the new combination treatment or the current standard treatment. After the treatment period, there will be a follow-up period where doctors will continue to monitor your health. The total duration of your participation will depend on the stage of the study and how your body responds to the treatment.

Potential risks and benefits

Potential benefits of joining this study include receiving a new experimental treatment for your cancer, which might be more effective than current options, and contributing to medical knowledge that could help future patients. However, like all medical treatments, there are potential risks and side effects associated with the drugs being used. The research team will carefully monitor you for any side effects, and you'll receive the best possible care. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (39)

Georgetown University Lombardi Cancer Center
Washington D.C., United States
Advent Health Cancer Institute
Orlando, United States
University Cancer and Blood Center LLC
Athens, United States
University of Kentucky
Lexington, United States
St. Louis University
St Louis, United States
Hackensack Meridian Health
Edison, United States
University Hospitals Of Cleveland
Cleveland, United States
Fox Chase Cancer Center
Philadelphia, United States
Vanderbilt University Medical Ctr
Nashville, United States
Novartis Investigative Site
Innsbruck, Austria
Novartis Investigative Site
Linz, Austria
Novartis Investigative Site
Vienna, Austria

+27 more sites — see the official record for the full list.

Common questions

What is Extensive Stage Small Cell Lung Cancer (ES-SCLC)?

It's an aggressive type of lung cancer that has spread from where it started to other parts of the body.

What is [177Lu]Lu-DOTA-TATE?

It's an experimental anti-cancer drug that uses a small amount of radiation to target and treat cancer cells.

Will I definitely get the new treatment if I join?

Not necessarily. In the main part of the study, participants are randomly assigned to either receive the new combination or the standard treatment, like flipping a coin.

How long will I be in the study?

The study involves a screening period, a treatment period (with induction and maintenance phases), and a follow-up period. The total time can vary for each person.

Can I leave the study at any time?

Yes, you are free to leave the study at any time, for any reason, without it affecting your medical care.