Active not recruitingPHASE2INTERVENTIONAL

Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

This study is looking at a new drug called Ifinatamab Deruxtecan (I-DXd) for people with advanced small cell lung cancer that has spread (extensive-stage). Participants in this study have already received other treatments, including platinum-based chemotherapy. The study has two main goals: firstly, to work out the safest and most effective dose of I-DXd, and secondly, to see how well this new drug fights the cancer in this group of patients. Researchers want to understand if it shrinks tumours or slows their growth. This is a Phase 2 study, meaning it's still in the earlier stages of human testing, focusing on drug safety and effectiveness for a specific condition.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Daiichi Sankyo

Enrolment target

187

Start

09 Mar 2022

Estimated completion

15 Dec 2026

Extensive-stage Small-cell Lung Cancer

What is this study about?

This study is focusing on a type of lung cancer called extensive-stage small cell lung cancer (ES-SCLC). "Extensive-stage" means the cancer has spread beyond the lung where it started or to other parts of the body. Unfortunately, these cancers are often aggressive and difficult to treat, especially after initial treatments. This research is important because it's testing a new medicine called Ifinatamab Deruxtecan (I-DXd) that could offer another option for patients who have already tried other standard therapies like chemotherapy.

The main aim of this study is to understand more about I-DXd. It's a two-part study. In the first part, researchers are trying to find the "best dose" of the drug. This means finding a dose that is effective against the cancer but also has manageable side effects. They will test two different doses for this. Once the best dose is found, the second part of the study will give that chosen dose to more participants to get a clearer picture of how well it works against the cancer and its overall safety.

Ultimately, this study aims to see if I-DXd can help people with this specific type of lung cancer. By carefully testing the drug, researchers hope to gain valuable information that could lead to new treatment options in the future. It's a stepping stone in scientific understanding and potentially improving care for patients with this challenging condition.

Key takeaways

Tests a new drug (I-DXd) for advanced small cell lung cancer.
Aimed at patients who have already received other treatments.
Will help determine the best dose and effectiveness of the new drug.
Involves regular clinic visits and monitoring.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you need to meet certain conditions. You must be at least 18 years old and have extensive-stage small cell lung cancer. Importantly, your cancer should have already been treated with at least one type of platinum-based chemotherapy, and you must have had two to three previous lines of treatment for your cancer. Your cancer should also have shown signs of getting worse after your most recent treatment. We will need to be able to take a small tissue sample (biopsy) from one of your cancer spots, and your general health and ability to perform daily activities should be quite good, as assessed by a doctor.

There are also some reasons why you might not be able to join the study. For example, if you've already had this specific drug or similar ones that work in the same way, you wouldn't be eligible. Also, if you have active brain tumours or other serious health problems like recent strokes or significant heart conditions, you might not be able to take part. Researchers also need to make sure your eyes and lungs are generally healthy, without certain pre-existing conditions like severe eye problems or a history of specific serious lung inflammation.

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 extensive-stage small cell lung cancer?
Have you already had at least one type of platinum-based chemotherapy?
Have you had 2-3 previous treatments for your cancer?
Has your cancer progressed or worsened after your last treatment?

Answer every question to see your result.

What does participation involve?

If you join this study, it will involve regular visits to the clinic. You will receive the study drug, Ifinatamab Deruxtecan (I-DXd), through an intravenous drip (into a vein) once every three weeks. The study will be divided into two main parts. In the first part, you would be randomly assigned to receive one of two different doses of the drug. In the second part, if you join then, everyone receives the same chosen dose.

Throughout the study, you'll have regular tests and assessments. These will include blood tests, scans (like CT scans) to see how your cancer is responding, and physical examinations. These checks are done to monitor the drug's effects, look for any side effects, and see how your body is handling the treatment. The total duration of your participation would depend on how your body responds to the treatment and the study design, continuing as long as the drug is benefiting you and you are tolerating it well.

Potential risks and benefits

Taking part in a clinical trial means you might be among the first to receive a new treatment that could potentially help your condition, especially if other treatments haven't worked for you. However, there's no guarantee the treatment will work, and you might not experience any benefits. All medicines have potential side effects, and since this is a new drug, some side effects might not be fully known yet. The research team will closely monitor you for any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (58)

Highlands Oncology Group
Verified postcode
Springdale, United States
The Cancer Specialists, Llc
Verified postcode
Jacksonville, United States
H. Lee Moffitt Cancer Center and Research Institute
Verified postcode
Tampa, United States
University of Chicago Medical Center
Verified postcode
Chicago, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Verified postcode
Baltimore, United States
Dana-Faeber Cancer Institute
Verified postcode
Boston, United States
Henry Ford Hospital
Verified postcode
Detroit, United States
Cancer and Hematology Centers of Western Michigan
Verified postcode
Grand Rapids, United States
Washington University School of Medicine
Verified postcode
St Louis, United States
Hackensack Meridian Health-Southern Ocean Medical Center
Verified postcode
Manahawkin, United States
Memorial Sloan-Kettering Cancer Center (Mskcc) - New York
Verified postcode
New York, United States
Montefiore Medical Center Prime
Verified postcode
The Bronx, United States

Common questions

What does 'extensive-stage small cell lung cancer' mean?

It means the cancer has spread beyond the lung where it started to other parts of the body.

What is Ifinatamab Deruxtecan (I-DXd)?

It's a new investigational drug being tested in this study to see how well it works against small cell lung cancer.

What is a Phase 2 study?

Phase 2 studies are early stages of human testing that look at how safe a new drug is and if it has any effect on the illness being studied.

Will I definitely get the new drug?

Yes, all participants in this study will receive the investigational drug I-DXd at one of the doses being tested.

Can I stop participating in the study at any time?

Yes, you have the right to withdraw from the study at any point without it affecting your routine medical care.