RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

This research study is looking at a new drug called zidesamtinib (also known as NVL-520) for people in the UK with advanced cancer that has a specific genetic change called a ROS1 rearrangement. This could be lung cancer or other types of solid tumours. The study has two main parts. The first part will help find the safest and most effective dose of the drug. The second part will then look at how well the drug works to shrink tumours and how long the benefits last in different groups of patients, including those who have had previous treatments. The main goal is to see if zidesamtinib can be a new treatment option.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Nuvalent Inc.

Enrolment target

359

Start

04 Jan 2022

Estimated completion

31 Dec 2028

Locally Advanced Solid Tumor Metastatic Solid Tumor

What is this study about?

This study, called ARROS-1, is investigating a new medication named zidesamtinib (or NVL-520). It's designed for people with advanced cancer where the cancer cells have a particular genetic change called a 'ROS1 rearrangement'. This genetic change can sometimes make cancer grow, and drugs that target this change can be effective. This study is aimed at understanding if zidesamtinib can be a safe and effective treatment option for these specific cancers.

The study is split into two phases. In Phase 1, a small number of patients will receive different doses of zidesamtinib. The doctors will carefully watch for any side effects and work out the best and safest dose to use for future patients. This is a crucial step for any new medication to ensure patient safety before giving it to more people.

Once the best dose is found, Phase 2 will involve more patients. Here, the focus will be on seeing how well zidesamtinib works to shrink tumours and control the cancer. Researchers will measure how many patients' tumours shrink, how long this shrinkage lasts, and how long people live without their cancer getting worse. They are particularly interested in people with a specific type of lung cancer called NSCLC, and also other types of solid tumours, both of which have the ROS1 change. Patients will be grouped based on their previous treatments to understand how the drug works in different situations.

Key takeaways

This study is testing a new drug, zidesamtinib, for advanced cancers with a specific ROS1 genetic change.
It aims to find the best dose and see how well the drug works to shrink tumours.
It's for people with certain types of advanced lung cancer or other solid tumours.
Patients will be carefully monitored for side effects and how their cancer responds.
Participation involves regular hospital visits, scans, and blood tests.

Who may be eligible?

To join this study, people generally need to be 18 years or older, though some younger patients (aged 12 and above) might be able to join one specific group if they have a non-lung solid tumour. Your doctors will need to confirm that your cancer has the specific 'ROS1 rearrangement' genetic change. You might have locally advanced cancer (meaning it has grown into nearby tissues) or metastatic cancer (meaning it has spread to other parts of the body).

There are different groups within the study, some for patients who haven't had previous drugs that specifically target ROS1, and others for those who have. You would need to have cancer that can be measured or evaluated by doctors. Also, your body's main organs and blood counts would need to be working well enough to participate in the study.

However, you would not be able to join if your cancer has other known genetic changes that drive its growth apart from ROS1. You also can't have had major surgery recently, be on another cancer drug or be taking part in another drug trial. If you're allergic to any of the ingredients in zidesamtinib, you also wouldn't be able to join.

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 or older (or 12-17 for certain non-lung tumours)?
Has your doctor confirmed your cancer has the 'ROS1 rearrangement'?
Is your cancer locally advanced or has it spread to other parts of your body?
Are your major organs (like liver, kidneys, and bone marrow) working well enough?
Are you not currently on other cancer treatments or part of another drug trial?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital for checks and tests. You would receive the study drug, zidesamtinib, possibly as a daily pill. The doctors and nurses would closely monitor you for any side effects and to see how your cancer is responding. This would include blood tests, scans (like CT or MRI scans) to measure your tumours, and physical examinations.

The study duration would depend on how your body responds to the treatment. You would continue to receive the drug as long as it is helping you and you are not experiencing severe side effects. Even after you stop taking the study drug, the team would likely want to follow up with you for a period to understand the long-term effects of the treatment and your overall health.

Potential risks and benefits

Taking part in a clinical trial may offer some potential benefits, such as receiving a new and innovative treatment before it’s widely available. The study drug, zidesamtinib, might help to shrink your tumour or slow its growth, but there is no guarantee it will work for everyone, or at all. Like all medicines, zidesamtinib may have side effects, which could be mild or serious. The study team will explain all known and potential risks to you and will monitor you closely. It's important to remember that you are free to withdraw from the study at any time, for any reason, without affecting your standard care.

Locations (63)

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

UCI Medical Center
Verified postcode
Orange, United States· Recruiting
Stanford Medicine
Verified postcode
Palo Alto, United States· Recruiting
UC Davis Comprehensive Cancer Center
Verified postcode
Sacramento, United States· Recruiting
University of Colorado Cancer Center
Verified postcode
Denver, United States· Recruiting
Georgetown University Medical Center
Verified postcode
Washington D.C., United States· Recruiting
University of Miami
Verified postcode
Coral Gables, United States· Recruiting
University of Chicago
Verified postcode
Chicago, United States· Recruiting
Mass General Hospital
Verified postcode
Boston, United States· Recruiting
Dana-Farber Cancer Institute
Verified postcode
Boston, United States· Recruiting
Henry Ford Cancer Institute
Verified postcode
Detroit, United States· Recruiting
Washington University School of Medicine
Verified postcode
St Louis, United States· Recruiting
NYU Langone Health
Verified postcode
New York, United States· Recruiting

Common questions

What is a 'ROS1 rearrangement'?

It's a specific genetic change in cancer cells that can make the cancer grow. This study is for people whose cancer has this particular change.

What type of cancer is this study for?

It's primarily for advanced lung cancer (NSCLC) with the ROS1 change, but also for other advanced solid tumours that have the same ROS1 change.

What is zidesamtinib (NVL-520)?

It's a new drug being tested in this study. It's designed to specifically target the cancer cells with the ROS1 genetic change.

Will I definitely get the new drug?

Yes, everyone in this study will receive the drug zidesamtinib. It’s not a study where some people get a placebo (a dummy drug).

What happens if the drug stops working?

If your cancer starts to grow or you experience too many side effects, your study doctor will discuss stopping the drug and exploring other treatment options with you.

How to find out more

Nuvalent

clinicaltrials@nuvalent.com 857-357-7000 Official trial record

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