Active not recruitingPHASE2INTERVENTIONAL

Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC

This research study is looking at a new medicine called taletrectinib for people with a kind of lung cancer known as ROS1-positive non-small cell lung cancer (NSCLC). This is a Phase 2 study, meaning the drug has already been tested for basic safety and now researchers want to learn more about how well it works and if it's safe for more people. About 214 patients will take part. Participants will take taletrectinib once a day in cycles, and doctors will regularly check how the cancer responds. The aim is to find better treatments for this specific type of lung cancer. The study is open to patients with advanced NSCLC who have a particular genetic change in their tumour called a ROS1 fusion.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Nuvation Bio Inc.

Enrolment target

217

Start

01 Sep 2021

Estimated completion

01 Dec 2027

Non Small Cell Lung Cancer

What is this study about?

This study is investigating a new drug called taletrectinib for people who have a specific type of lung cancer. This cancer is known as Non-Small Cell Lung Cancer (NSCLC) and has a particular genetic change called a ROS1 fusion. If you have this type of cancer, it means your cancer cells have a faulty gene that can cause them to grow. Taletrectinib is designed to target this specific faulty gene.

This is a 'Phase 2' study, which means researchers are building on earlier work that showed the drug was generally safe. Now, they want to learn more about how effective taletrectinib is at shrinking cancer or stopping its growth, and to continue monitoring its safety in a larger group of people. The study involves about 214 patients from around the world. All patients will receive taletrectinib, and doctors will closely watch how their cancer responds to the treatment.

The main goal is to see if taletrectinib can be a new and better treatment option for advanced ROS1-positive NSCLC. This kind of research is really important because it helps scientists understand new medicines and potentially offer more choices for people living with cancer.

Key takeaways

This study is testing a new drug for a specific lung cancer type.
It's for people with ROS1-positive non-small cell lung cancer.
The drug, taletrectinib, is taken once daily.
Participation involves regular checks to see how the cancer responds.
Researchers want to understand both safety and effectiveness.
You can stop participating at any time.

Who may be eligible?

To join this study, you generally need to be at least 18 years old (or 20 in some areas) and have a confirmed diagnosis of advanced Non-Small Cell Lung Cancer (NSCLC) that includes a specific change called a ROS1 fusion gene. This cancer might be locally advanced (meaning it has spread a bit but not to distant parts of the body) or metastatic (meaning it has spread further).

Doctors will need to confirm the ROS1 fusion gene using a special test on a sample of your tumour. This might be from an existing tissue sample or, if needed, you might have a new biopsy. If your cancer has spread to your brain or spinal cord, you might still be able to join, but it needs to be stable and well-managed, for example with stable medication or if previous treatments like radiation have finished some time ago.

The study is divided into different groups based on whether you've had previous treatments for your ROS1-positive lung cancer. The research team will carefully check all your medical information to see if you meet all the specific requirements for one of these groups.

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.

Am I at least 18 years old?
Do I have a diagnosis of advanced Non-Small Cell Lung Cancer (NSCLC)?
Has my doctor confirmed that my cancer has a ROS1 fusion gene?
Is my general health stable enough for a clinical trial?
If my cancer has spread to my brain, is it stable and well-managed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the study drug, taletrectinib, once a day. This treatment will be given in cycles, with each cycle lasting 21 days. You will continue taking taletrectinib as long as the doctors find that it is helping your cancer and you are tolerating the treatment well. The treatment will stop if your cancer starts to grow again or if you experience side effects that make it unsafe to continue.

Throughout the study, you will have regular check-ups and tests. These will help doctors monitor how your cancer is responding to the treatment and to keep an eye on your overall health. These tests will include checks to see if your tumour has shrunk or stopped growing. Even after you stop the treatment, doctors will continue to follow up with you for a longer period to understand the long-term effects of the drug. The study does not specify the exact number of visits, but you can expect regular appointments for assessments and medication refills.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of this study is that you might receive a new treatment that could be more effective for your specific type of lung cancer than standard options. However, there's no guarantee that taletrectinib will work for everyone, and it might not work for you. Like all medicines, taletrectinib may cause side effects, and these could be mild or more serious. The research team will thoroughly explain all known and potential risks before you decide to join. It is very important to remember that participating in a clinical trial is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (77)

Beverly Hills Cancer Center
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Beverly Hills, United States
The Oncology Institute of Hope and Innovation
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Glendale, United States
Moores Cancer Center at UC San Diego
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La Jolla, United States
Keck Medicine of University of Southern California
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Los Angeles, United States
UCI Medical Center
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Orange, United States
Ventura County Hematology-Oncology Specialists
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Oxnard, United States
SCRI - Florida Cancer Specialists South
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Fort Meyers, United States
Memorial Cancer Institute at Memorial Hospital East
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Hollywood, United States
Cancer Specialists of North Florida
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Jacksonville, United States
Memorial Cancer Institute at Memorial Hospital West
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Pembroke Pines, United States
SCRI - Hematology Oncology Clinic
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Baton Rouge, United States
Mayo Clinic
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Rochester, United States

Common questions

What is ROS1-positive Non-Small Cell Lung Cancer?

It's a specific type of lung cancer where the cells have a faulty gene called ROS1, which helps the cancer grow. The study drug, taletrectinib, is designed to target this fault.

What does 'Phase 2 study' mean?

It means the drug has passed initial safety tests, and now researchers are focusing on how well it works against the cancer and continuing to monitor its safety in a larger group of patients.

How often will I take the study drug?

You will take taletrectinib once a day, and the treatment will be organised into 21-day cycles. You'll continue as long as it's helping and you're feeling okay.

What kind of tests will I have during the study?

You'll have regular checks to see how your cancer is responding to the treatment, likely including scans and other medical assessments. This helps doctors see if the drug is working.

Can I leave the study at any time?

Yes, absolutely. Your participation is voluntary, and you can choose to leave the study at any point without it affecting your ongoing medical care.