AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody Drug Conjugate (ADC), Compared to Investigator’s Choice Therapy in Participants with Relapsed Small Cell Lung Cancer

This research is looking at a new treatment called ZL-1310 for small cell lung cancer that has returned. The study will give some participants ZL-1310, while others will receive standard chemotherapy like Topotecan. Doctors want to find out if ZL-1310 is more effective at shrinking the cancer and helping people live longer compared to current treatments. They will also carefully monitor any side effects and how the treatment affects patients' quality of life. This is a Phase 3 study, which means it's a key step in determining if ZL-1310 could become a new approved treatment.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Zai Lab (US) LLC

Enrolment target

131

Start

08 Jun 2026

Small Cell Lung Cancer (SCLC)

What is this study about?

This study is focusing on a type of cancer called Small Cell Lung Cancer (SCLC). Sometimes, after initial treatment, this cancer can return. The researchers are testing a new drug named ZL-1310. This drug is part of a newer class of treatments designed to target cancer cells more precisely.

The main goal of this study is to see if ZL-1310 can shrink the cancer more effectively and help people live longer compared to the treatments doctors currently choose. These standard treatments often include chemotherapy drugs like Topotecan. By comparing the new drug to established methods, the researchers can understand its potential benefits. They will also be looking closely at how the new drug affects patients' day-to-day lives, including any side effects and their general well-being.

This is a 'Phase 3' study, which is a big step in testing new medicines. It means a larger number of patients are involved, and the results from this study will be very important in deciding if ZL-1310 could become a new option for treating small cell lung cancer in the future.

Key takeaways

Tests a new drug (ZL-1310) for small cell lung cancer that has returned.
Compares the new drug to standard chemotherapy like Topotecan.
Aims to see if ZL-1310 shrinks cancer more effectively and improves survival.
Involves regular check-ups, scans, and questionnaires.
Patients are adults aged 18 or older.
You can leave the study at any time.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 or older. It is open to both men and women.

Since the study is for small cell lung cancer that has come back, you would need to have received previous treatment for this type of cancer and your cancer would have to have returned after that treatment.

There will be other detailed medical checks to make sure the study is a good fit for you and that it's safe for you to take part. These checks will be explained by the study team.

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?
Have you been diagnosed with Small Cell Lung Cancer (SCLC)?
Has your small cell lung cancer returned after previous treatment?
Are you able to attend regular hospital visits for treatment and checks?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to receive either the new drug ZL-1310 or a standard treatment that your doctor chooses, such as Topotecan. This is like flipping a coin, so neither you nor your doctor can choose which treatment you receive.

You'll have regular visits to the clinic for treatments, check-ups, and tests like scans, blood tests, and questionnaires about how you're feeling. These visits will help the doctors understand how the treatment is working and monitor your health. You'll continue treatment for as long as it's helping and you're not experiencing severe side effects. After your treatment ends, there will be follow-up appointments to track your health over time. The total duration of participation will depend on how you respond to treatment and the follow-up period, but it can extend for quite a while.

Potential risks and benefits

Taking part in a clinical trial offers the chance to try a new treatment that might be more effective than current options, especially if your cancer has returned. However, there's no guarantee the new drug will work for you, and like all medications, ZL-1310 could have side effects, which the study team will monitor closely. You might also experience side effects from the standard treatments. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

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

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Unverified
Belgium
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Unverified
Czechia
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Unverified
Denmark
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Unverified
Greece
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Unverified
Netherlands
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Unverified
Spain
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Unverified
Austria
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Unverified
Italy

Common questions

What is small cell lung cancer?

It's a fast-growing type of lung cancer that can spread quickly.

What does 'relapsed' mean?

It means the cancer has come back after a period of being under control with previous treatment.

What is ZL-1310?

It's a new experimental drug being tested to treat small cell lung cancer.

Will I know if I'm getting the new drug or standard treatment?

No, this is an 'open-label' study meaning both you and your doctor will know which treatment you are receiving.

What is a 'Phase 3' study?

It's a key stage where a new drug is compared to existing treatments in a larger group of patients to confirm its effectiveness and safety.