AuthorisedTherapeutic confirmatory (Phase III)Interventional

Randomized, Open-Label, Phase 3 Clinical Trial of N-803 Plus Tislelizumab and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer who Have Acquired Resistance to Immune Checkpoint Inhibitor Therapy

This phase 3 study investigates new ways to treat advanced or metastatic non-small cell lung cancer, specifically in patients whose cancer has stopped responding to certain immune-boosting treatments. The trial is comparing two treatment approaches: a combination of three different medicines (N-803, tislelizumab, and docetaxel) against one medicine by itself (docetaxel). The main goal is to see if the combination treatment helps people live longer and is more effective. Researchers will also look at how safe the new combination is and how well it shrinks tumours or stops them from growing. This research is important for finding better options for people with this type of lung cancer.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Immunitybio Inc.

Enrolment target

206

Start

26 Aug 2025

Advanced or Metastatic Non-Small Cell Lung Cancer

What is this study about?

This study is a research trial for people who have advanced or metastatic non-small cell lung cancer. "Advanced" means the cancer has grown into nearby tissues or spread to nearby lymph nodes, while "metastatic" means it has spread to other parts of the body.

Patients taking part in this study have already had a type of treatment called "immune checkpoint inhibitor therapy." This is a treatment that helps your own immune system fight the cancer. However, in this study, the cancer has unfortunately become resistant to these previous immune treatments, meaning they are no longer working as effectively. The researchers want to find out if a new combination of medicines can help these patients.

The study is comparing two different treatment approaches. One group will receive a combination of three medicines: N-803, tislelizumab, and docetaxel. Another group will receive docetaxel on its own. Docetaxel is a type of chemotherapy. N-803 and tislelizumab are newer types of treatments that aim to boost the body's immune response against cancer. The main goal of the study is to see if the new combination helps people live longer compared to receiving docetaxel alone. They will also look at other factors, like how well the treatments shrink the cancer and how safe they are.

Key takeaways

This study is for advanced lung cancer that is no longer responding to immune-boosting treatments.
It compares a new combination of three drugs against an existing chemotherapy.
The main goal is to see if the new combination can help people live longer.
Participation involves regular hospital visits for treatment and monitoring.
You will be randomly assigned to one of the two treatment groups.
You can stop participating in the study at any time.

Who may be eligible?

To be considered for this study, you must be 18 years old or older. The study is open to both men and women.

You would generally be considered if you have a type of lung cancer called non-small cell lung cancer, and it is advanced (meaning it has grown locally) or metastatic (meaning it has spread to other parts of your body). Importantly, your cancer would have needed to stop responding to an earlier treatment that worked by helping your immune system fight the cancer.

There will be other specific medical checks and tests that the study doctors will need to carry out to make sure the study treatment is suitable and safe for you. This helps protect your health and ensures that the results of the study are reliable.

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 advanced or metastatic non-small cell lung cancer?
Has your cancer previously been treated with immune checkpoint inhibitor therapy?
Has your cancer now stopped responding to that immune checkpoint therapy?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of two treatment groups, like flipping a coin. You will either receive the combination of N-803, tislelizumab, and docetaxel, or you will receive docetaxel on its own. Neither you nor your doctor will get to choose which treatment you receive. Both treatments are given through a drip (infusion) into your vein. The specific schedule and number of visits will be outlined by the study team, but typically involve regular hospital visits for treatment and check-ups.

During your time in the study, you will have regular medical appointments, which will include physical examinations, blood tests, and scans (like CT scans) to see how your body is responding to the treatment and to monitor for any side effects. These tests help the doctors track your progress and ensure your safety. You will continue treatment for as long as it is working for you and if any side effects are manageable. After treatment stops, you'll have follow-up appointments to monitor your health over time. The total duration of active treatment and follow-up will vary for each person but will be clearly explained by the study team.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as access to new combination therapies that are not yet widely available. The study might help researchers find better ways to treat advanced lung cancer, which could eventually benefit many people. However, there are also potential risks involved. All medicines can have side effects, and the combination of treatments might lead to new or more intense side effects. These could include feeling sick, tiredness, hair loss, or more serious reactions. The study team will carefully monitor you for any side effects and will explain all known risks to you before you agree to participate. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

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

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Unverified
Germany
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Unverified
Hungary
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Unverified
Spain
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Unverified
Poland
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Unverified
Greece
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Unverified
Belgium
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Unverified
France
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Unverified
Italy
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Unverified
Romania

Common questions

What does a 'Phase 3' study mean?

A Phase 3 study is a large study that compares a new treatment with an existing one (or a placebo) to confirm its effectiveness and safety before it can be approved for wider use.

What is 'Non-Small Cell Lung Cancer'?

This is the most common type of lung cancer, accounting for about 80% to 85% of all lung cancers. It's often treated differently from 'small cell' lung cancer.

What are 'immune checkpoint inhibitors'?

These are medicines that help your body's own immune system recognise and fight cancer cells by taking off the 'brakes' that stop the immune system from attacking cancer.

Why is this study looking at combination treatments?

Often, combining different treatments can be more effective than using just one, especially when a cancer has become resistant to previous therapies.

Will I know which treatment I am receiving?

No, this is an 'open-label' study, meaning you and your doctors will know which treatment you are receiving once you are assigned to a group.