A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
This research study is for people with a type of lung cancer called small cell lung cancer (SCLC) that has returned after initial treatment. The study aims to find out if a new medicine, ifinatamab deruxtecan (I-DXd), is more effective and safer than current standard treatments chosen by doctors. Researchers will be looking at how well the cancer responds and how long people live. They will also collect information on side effects, how people feel day-to-day, and how the medicine works in the body. If you have SCLC that has come back, this study might be an option to discuss with your doctor.
At a glance
What is this study about?
This study, called a Phase 3 trial, is investigating a new medication, ifinatamab deruxtecan (I-DXd), for people whose small cell lung cancer (SCLC) has returned after their first round of treatment. SCLC can be a challenging cancer, and researchers are always looking for better ways to treat it. This particular study wants to see if I-DXd can help people live longer or shrink their cancer more effectively than the treatments doctors currently choose, such as Topotecan, Amrubicin, or Lurbinectedin.
The main goal is to measure how many people respond to the treatment (meaning their cancer shrinks or stops growing) and how long people stay alive after starting treatment. To do this, half of the participants will receive I-DXd, and the other half will receive one of the standard treatments. This comparison helps researchers understand if I-DXd is a better option.
Beyond just how effective it is, the study will also carefully check for any side effects and how they affect daily life. They will also look into how the new drug moves through the body, any immune reactions, and markers in the cancer itself. Collecting all this information helps researchers get a complete picture of if and how this new treatment could help people with SCLC.
Key takeaways
- This study evaluates a new drug (I-DXd) for relapsed small cell lung cancer.
- It compares I-DXd to existing standard treatments.
- The main goals are to check how well it shrinks cancer and helps people live longer.
- If you have SCLC that has returned, you might be eligible.
- You will be closely monitored, but there are potential risks and benefits.
- Discuss with your doctor if this study could be right for you.
Who may be eligible?
To join this study, you must be at least 18 years old and have small cell lung cancer that has spread and has come back after only one previous course of platinum-based chemotherapy. Your cancer must have been confirmed by a biopsy, and you need to have cancer that can be measured on scans.
There are also some important health checks. You need to be generally well enough to take part, with a good level of physical activity. Doctors will also check that you don't have certain other health issues or active brain cancer that requires immediate treatment. You also can't have been treated with certain related drugs before.
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 that has come back?
- Have you only had one previous chemotherapy treatment for your cancer?
- Are you generally well enough for daily activities?
- Do you have measurable cancer on a scan?
- Have you not received certain related treatments before?
What does participation involve?
If you decide to join this study, you'll first have some assessments to confirm you're eligible. Once enrolled, you'll be randomly assigned to receive either the new study drug (ifinatamab deruxtecan) or one of the standard treatments for your type of cancer. You won't get to choose which treatment you receive, and neither will your doctor.
The treatment will involve regular visits to the clinic for your medication and various tests, such as blood tests, scans to check your cancer, and physical exams. You'll also be asked to complete questionnaires about how you're feeling and how the treatment is affecting your quality of life. The study duration will vary depending on your treatment and how your body responds, but you will have regular follow-up appointments even after treatment ends to monitor your health and the cancer's status.
Potential risks and benefits
Locations (232)
- Highlands Oncology GroupVerified postcodeSpringdale, United States· Recruiting
- Clinical Research Providence Medical FoundationVerified postcodeFullerton, United States· Recruiting
- UCLA Hematology-OncologyVerified postcodeLos Angeles, United States· Recruiting
- UCSF Mission Bay Mission HallVerified postcodeSan Francisco, United States· Recruiting
- University of Miami Hospital and Clinics Sylvester Comprehensive Cancer CenterVerified postcodeMiami, United States· Recruiting
- AdventHealth Orlando, Cancer InstituteVerified postcodeOrlando, United States· Recruiting
- H. Lee Moffitt Cancer Center and Research Institute, IncVerified postcodeTampa, United States· Not yet recruiting
- Rush MD Anderson Cancer CenterVerified postcodeChicago, United States· Recruiting
- Baptist Health LexingtonVerified postcodeLexington, United States· Recruiting
- University of Maryland Greenebaum Comprehensive Cancer CenterVerified postcodeBaltimore, United States· Recruiting
- John Hopkins School of MedicineVerified postcodeBaltimore, United States· Recruiting
- Dana-Farber Cancer InstituteVerified postcodeBoston, United States· Recruiting
Common questions
What is small cell lung cancer?
Small cell lung cancer (SCLC) is a fast-growing type of lung cancer often linked to smoking. It tends to spread quickly.
What does 'relapsed' mean?
'Relapsed' means the cancer has come back after it was successfully treated or stopped growing for a period of time.
What is ifinatamab deruxtecan (I-DXd)?
I-DXd is an investigational new medicine. It's designed to target cancer cells and deliver an anti-cancer drug directly to them.
What are 'standard treatments'?
Standard treatments are medicines like Topotecan, Amrubicin, or Lurbinectedin that doctors currently use to treat small cell lung cancer that has returned.
Will I know which treatment I'm getting?
No, you will be randomly assigned to either the new drug or a standard treatment. Neither you nor your doctor will get to choose or know which one you receive initially.
How to find out more
Daiichi Sankyo Contact for Clinical Trial Information
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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