AuthorisedTherapeutic exploratory (Phase II)Interventional

AUSTRAL trial: An open-label, multicenter, phase II study of radiotherapy followed by durvalumab (MEDI4736) and ceralasertib (AZD6738) in stage III NSCLC patients with thoracic relapses +/- oligometastases after PACIFIC regimen

This study, called AUSTRAL, is for people with a type of lung cancer called stage III non-small cell lung cancer (NSCLC) that has come back in the chest or spread a little to other areas. It's for patients who have already had a standard treatment called PACIFIC. The study is testing a new treatment approach that involves radiation therapy followed by two medicines: durvalumab and ceralasertib. Researchers want to find out if this combination treatment is safe and whether it helps to control the cancer and improve how long people live without their cancer getting worse. It's a Phase II study, meaning it's an earlier stage trial to gather more information on effectiveness and safety.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Istituto Di Ricerche Farmacologiche Mario Negri

Enrolment target

Start

03 Jul 2025

regardless of PD-L1 status but without EGFR HER-2 or MET exon14 skipping mutations ALK ROS1 RET or NTRK rearrangements.

What is this study about?

This study, called AUSTRAL, is looking into a new treatment for a specific type of lung cancer. It's for people who have stage III non-small cell lung cancer (NSCLC) that has returned in the chest area, or perhaps spread to a very small number of other places. This specific group of patients has already had a common treatment called PACIFIC, which involves chemotherapy and radiotherapy, followed by a drug called durvalumab. The cancer has come back more than 12 months after this previous treatment finished.

The research aims to see if adding a new drug, called ceralasertib, to the existing durvalumab, after getting more radiation therapy, can be a better way to treat this recurring cancer. Durvalumab is a type of immunotherapy that helps your body's immune system fight cancer. Ceralasertib is a newer drug that is being investigated to see how it works with durvalumab and radiation.

Primarily, the doctors want to check how safe this new combination treatment is. They will be carefully watching for any side effects, especially serious ones. They also want to know how well the treatment works in stopping the cancer from growing or spreading. This includes looking at how long people live without their cancer getting worse, and how many people respond to the treatment.

Key takeaways

This study is for people with stage III lung cancer that has returned after previous treatment.
It tests a new combination of radiation therapy plus two drugs: durvalumab and ceralasertib.
The main goals are to check the treatment's safety and effectiveness in controlling the cancer.
It's a Phase II study, meaning it's an earlier trial to gather more information.
Patients must meet specific criteria, including having no certain genetic changes in their cancer.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with stage III non-small cell lung cancer (NSCLC). To be considered, your cancer must have returned in your chest area, or you might have a very small number (less than 3) of new cancer spots in other parts of your body.

You must have completed a standard treatment called the PACIFIC regimen (which includes chemotherapy, radiotherapy, and then durvalumab) at least 12 months ago. It's important that your cancer does not have certain specific genetic changes, such as EGFR, HER-2, MET exon14 skipping, ALK, ROS1, RET, or NTRK mutations/changes. Your doctors will check for these through tests.

Both men and women can join this study. Before joining, the study team will carefully review your medical history and conduct tests to make sure the treatment is suitable and safe 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.

Are you 18 years old or older?
Do you have Stage III non-small cell lung cancer that has come back in your chest, or with very few other spots?
Did you complete the PACIFIC treatment (chemo, radiation, then durvalumab) over a year ago?
Has your doctor confirmed your cancer does not have specific genetic changes (like EGFR, ALK, etc.)?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first undergo a round of radiation therapy. After the radiation, you will receive two medicines: durvalumab and ceralasertib. These drugs will be given over a period of time. You will have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is working. The exact frequency and duration of these visits will be explained by the study team. You'll continue to be followed up even after your active treatment phase finishes to see how you're doing in the long term. The total duration of your participation will depend on how you respond to the treatment and the study's follow-up plan.

Potential risks and benefits

Participating in this study might offer you access to a new treatment combination before it's widely available. The study aims to see if this treatment can help control your cancer. However, as with any medical treatment, there are potential risks, including side effects from the radiation and the two drugs. Some side effects could be serious. The study team will explain all known side effects in detail. You are free to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (1)

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

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Unverified
Italy

Common questions

What is Stage III NSCLC?

Stage III NSCLC means non-small cell lung cancer that is locally advanced, meaning it has spread within the chest but typically not widely to distant parts of the body.

What is the PACIFIC regimen?

The PACIFIC regimen is a standard treatment for Stage III NSCLC involving chemotherapy, radiation therapy, followed by a drug called durvalumab to help prevent the cancer from returning.

What are durvalumab and ceralasertib?

Durvalumab is a type of immunotherapy that helps your immune system fight cancer. Ceralasertib is a newer drug being tested to see how it works in combination with durvalumab and radiation.

What does 'Phase II' mean?

A Phase II study is an earlier stage of clinical trial that focuses on checking the safety of a new treatment and how well it works for a particular condition.

What are 'side effects'?

Side effects are unwanted reactions or problems that can occur as a result of medical treatment. The study team will monitor you closely for any side effects.