RecruitingPHASE3INTERVENTIONAL

Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC

This research study is looking at a new medicine called neladalkib (NVL-655) for a specific type of lung cancer. This cancer is called non-small cell lung cancer (NSCLC) and has a particular genetic change known as ALK-positive. The study aims to find out if neladalkib is better than a standard drug, alectinib, at keeping the cancer from getting worse. This is for people who haven't had previous drug treatment for their advanced lung cancer. Half the participants will receive neladalkib, and the other half will receive alectinib. Doctors hope neladalkib will help patients live longer without their cancer growing.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Nuvalent Inc.

Enrolment target

450

Start

17 Jul 2025

Estimated completion

01 Dec 2029

Non-small Cell Lung Cancer Anaplastic Lymphoma Kinase-positive

What is this study about?

This study is for people who have advanced non-small cell lung cancer (NSCLC) that has a specific change in their genes called ALK-positive. This type of lung cancer can sometimes be treated with special drugs that target this ALK change.

The main goal of this study is to see if a new drug, neladalkib, can stop the cancer from growing for longer compared to a common treatment called alectinib. Researchers want to find out if neladalkib is a more effective option for people who haven't had these types of targeted treatments before. By comparing these two medicines, doctors hope to offer better treatment choices in the future.

In this study, patients will be randomly assigned to receive either neladalkib or alectinib. This means a computer will decide which drug you get, much like flipping a coin, to make sure the comparison is fair. Doctors will then closely monitor how well each drug works in slowing down or stopping the cancer's growth.

Key takeaways

Tests a new lung cancer drug (neladalkib) vs a standard one (alectinib).
For advanced, ALK-positive non-small cell lung cancer.
Only for patients new to targeted treatments for advanced cancer.
Aims to see if neladalkib stops cancer growth for longer.
You will know which drug you are taking.
Close medical monitoring during the study.

Who may be eligible?

This study is looking for adults aged 18 or over. You must have advanced non-small cell lung cancer (NSCLC) that has been confirmed to have a specific genetic change called ALK-positive. Your cancer must be able to be measured by doctors.

It's important that you haven't had any previous drug treatments for your advanced lung cancer. However, if you had chemotherapy for earlier-stage lung cancer more than a year ago, you might still be able to join. You cannot have received any ALK-targeting drugs like alectinib before.

There are also some reasons why you might not be able to join, such as having another active cancer, certain heart problems, uncontrolled infections, or known allergies to the study drugs. Doctors will check all these things carefully to make sure the study is 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.

Do I have advanced non-small cell lung cancer?
Has my cancer been confirmed as 'ALK-positive'?
Have I not had any targeted drug treatments for my advanced lung cancer before?
Do I have cancer that can be measured on a scan?
Am I over 18 years old?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be assigned to take either neladalkib or alectinib. You'll take your study medicine every day. Throughout the study, you'll have regular visits to the clinic for medical check-ups, blood tests, and scans (like CT scans) to see how your cancer is responding and to keep an eye on your overall health. Doctors will take samples of your tumour tissue before you start the study.

The study will continue for as long as the medicine is helping to control your cancer and you are feeling well enough to continue. After you stop taking the study medicine, there will be follow-up appointments to monitor your health. The total duration of participation will vary for each person depending on how their cancer responds and their health, but it often involves regular check-ups over several months or even years.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit if the new drug, neladalkib, works better than the standard treatment. You’ll also receive close medical attention and monitoring throughout the study. However, all medicines have potential side effects, and both neladalkib and alectinib could cause unwanted effects. These will be explained to you by the study team. There’s also no guarantee that the treatment will work for you. You are free to withdraw from the study at any time for any reason, without it affecting your future medical care.

Locations (155)

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

Palo Verde Hematology Oncology
Verified postcode
Glendale, United States· Recruiting
Hoag Hospital Newport Beach
Verified postcode
Newport Beach, United States· Recruiting
University of California, Irvine Health
Verified postcode
Orange, United States· Recruiting
Rocky Mountain Cancer Centers
Verified postcode
Boulder, United States· Recruiting
Sylvester Comprehensive Cancer Center Miami
Verified postcode
Miami, United States· Recruiting
AdventHealth Cancer Institute
Verified postcode
Orlando, United States· Recruiting
H Lee Moffitt Cancer Center and Research Institute
Verified postcode
Tampa, United States· Recruiting
Winship Cancer Institute of Emory University
Verified postcode
Atlanta, United States· Recruiting
Dana-Farber Cancer Institute
Verified postcode
Boston, United States· Recruiting
Barbara Ann Karmanos Cancer Institute
Verified postcode
Detroit, United States· Withdrawn
Washington University Center for Advanced Medicine
Verified postcode
St Louis, United States· Recruiting
NYU Langone's Perlmutter Cancer Center
Verified postcode
New York, United States· Recruiting

Common questions

What is 'ALK-positive' lung cancer?

It means your lung cancer cells have a specific genetic change that doctors can sometimes target with special medicines.

What does 'TKI-naive' mean?

It means you haven't had a type of targeted drug called a 'tyrosine kinase inhibitor' (TKI) for your advanced lung cancer before.

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

Yes, this is an 'open-label' study, meaning both you and your doctor will know which treatment you are receiving.

What is 'progression-free survival'?

It's the amount of time someone lives with cancer without their cancer growing or getting worse.

How long will I be in the study?

You'll be in the study for as long as the treatment is helping you and you're feeling well, and then have follow-up check-ups.

How to find out more

Nuvalent Clinical Trials

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

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