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RecruitingPHASE3INTERVENTIONAL

A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE)

The DLLEVATE study is testing a new medicine called ZL-1310 for people whose small cell lung cancer has returned after previous treatments. This study aims to see how effective and safe ZL-1310 is compared to other treatments doctors might usually choose. Small cell lung cancer is a type of lung cancer that can grow quickly. If you have this type of cancer and it has come back, or 'relapsed', after initial treatment, you might be able to take part. The study involves comparing ZL-1310 with existing treatment options to understand if it could be a better way to help patients. Doctors will carefully monitor participants to see if the new medicine helps shrink the cancer and how well people tolerate it.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Zai Lab (Shanghai) Co., Ltd.
Enrolment target
480
Start
30 Nov 2025
Estimated completion
30 Nov 2028

What is this study about?

This study, known as DLLEVATE, is focusing on small cell lung cancer, a type of lung cancer that often grows quickly. Standard treatments are usually used first, but sometimes the cancer comes back, or 'relapses'. When this happens, doctors need more options to help patients. This research is important because it's looking into a new potential treatment called ZL-1310.

The main goal of the DLLEVATE study is to find out if ZL-1310 is a safe and effective treatment for people whose small cell lung cancer has returned. To do this, researchers will compare ZL-1310 with treatments that doctors currently use in these situations. By carefully comparing these treatments, the study aims to understand if ZL-1310 could become a new, better choice for patients.

Taking part in a study like this helps doctors learn more about cancer and develop new medicines. The information gathered from participants will help improve care for future patients with small cell lung cancer. Every step of the study is carefully planned to ensure patient safety and collect useful information.

Key takeaways

  • The study is for people with small cell lung cancer that has come back.
  • It compares a new drug (ZL-1310) to standard treatments.
  • Participation involves regular check-ups, scans, and blood tests.
  • You will be closely monitored for any side effects.
  • Joining is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, people generally need to be at least 18 years old and have small cell lung cancer that has been confirmed by a doctor. This cancer must also have come back after you've had at least one round of chemotherapy with platinum-based drugs. Your doctors will need to be able to measure your cancer, meaning they can see and track its size. You should also be generally well enough to take part in a study, as judged by your doctor, and able to do most of your daily activities.

There are also some reasons why you might not be able to join. For example, if you've already had many rounds of treatment for your cancer, or if you've recently had other cancer medications. Certain other health conditions, like severe lung problems or serious heart issues, could also prevent you from participating. Your doctor will review all your health information carefully to see if this study is suitable for you.

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.

  1. Are you 18 years old or older?
  2. Has a doctor confirmed you have small cell lung cancer?
  3. Has your cancer come back after at least one previous chemotherapy treatment?
  4. Are you generally well enough for a clinical study?
  5. Are your doctors able to measure and track your cancer?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the new medicine, ZL-1310, or a treatment your doctor would normally choose. This will involve regular visits to the clinic for check-ups, blood tests, and scans to see how you're responding to the treatment. You might be asked to provide a small sample of your tumour (a biopsy) or existing tissue from a previous biopsy for extra tests. The doctors and nurses will monitor you closely for any side effects or changes in your health. The total time you'll be in the study will depend on how your treatment progresses, but you'll have regular follow-up appointments.

Potential risks and benefits

Participating in this study might offer the potential benefit of accessing ZL-1310, a new treatment that isn't widely available yet, which could help your cancer. However, like all medicines, ZL-1310 can have side effects, and it might not work for everyone. The 'Investigator's Choice Therapy' also has its own known risks and benefits. Doctors will explain all potential risks and side effects of both options as fully as they can. Remember, joining a study is always your choice, and you are free to withdraw at any time without affecting your future medical care.

Locations (66)

  • Zai Lab Site 02050
    Verified postcode
    La Jolla, United States· Recruiting
  • Zai Lab Site 02033
    Verified postcode
    Sacramento, United States· Recruiting
  • Zai Lab Site 02037
    Verified postcode
    Aurora, United States· Recruiting
  • Zai Lab Site 02030
    Verified postcode
    New Haven, United States· Recruiting
  • Zai Lab Site 02045
    Verified postcode
    Clermont, United States· Recruiting
  • Zai Lab Site 02031
    Verified postcode
    Orange City, United States· Recruiting
  • Zai Lab Site 02020
    Verified postcode
    Rockledge, United States· Recruiting
  • Zai Lab Site 02026
    Verified postcode
    Sarasota, United States· Recruiting
  • Zai Lab Site 02052
    Verified postcode
    St. Petersburg, United States· Recruiting
  • Zai Lab Site 02047
    Verified postcode
    Tampa, United States· Recruiting
  • Zai Lab Site 02051
    Verified postcode
    West Palm Beach, United States· Recruiting
  • Zai Lab Site 02021
    Verified postcode
    Peoria, United States· Recruiting

Common questions

What is small cell lung cancer?

It's a type of lung cancer that can grow and spread quickly. This study is for people whose cancer has returned after initial treatment.

What is ZL-1310?

ZL-1310 is a new medicine being tested in this study to see if it can help treat relapsed small cell lung cancer.

Will I definitely get the new medicine?

You will either receive ZL-1310 or a standard treatment that your doctor would normally recommend. Which one you get is decided by chance.

What does 'relapsed' mean?

It means your cancer has come back or started to grow again after you've had previous treatments for it.

Can I stop being part of the study once I start?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your future medical care.

How to find out more

ZL-1310-003 Study Team

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study of ZL-1310 Versus Investigator's Choice of Therapy i…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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