RecruitingPHASE3INTERVENTIONAL

Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations

This important study is investigating a new treatment approach for people with advanced or metastatic non-small cell lung cancer (NSCLC). Researchers want to find out if combining two medicines, Dato-DXd and pembrolizumab, works better than pembrolizumab alone. This study focuses on people who have a specific type of NSCLC that hasn't spread widely, and whose cancer has high levels of a protein called PD-L1. They also haven't received other treatments for their advanced cancer. The main goal is to see if the new combination can help people live longer or stop their cancer from growing for a longer time, while also checking for any side effects. Participants will be split into two groups, one getting the new combination and the other getting pembrolizumab only, to compare the results fairly.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Daiichi Sankyo

Enrolment target

740

Start

04 Mar 2022

Estimated completion

30 Apr 2028

Metastatic Non Small Cell Lung Cancer

What is this study about?

This study is all about finding better ways to treat a type of lung cancer called non-small cell lung cancer (NSCLC) when it's advanced or has spread to other parts of the body (this is called metastatic). Doctors are looking at a new treatment that combines two different medicines: Dato-DXd and pembrolizumab. Pembrolizumab is a type of immunotherapy that helps your body's own immune system fight cancer, and Dato-DXd is a new drug that specifically targets cancer cells.

The main idea behind this study is to see if giving these two medicines together is more effective and just as safe as giving pembrolizumab by itself. They are focused on people whose cancer has a high level of a specific marker called PD-L1, which can suggest that immunotherapy might work well. It's also for people who haven't had other treatments for their advanced lung cancer before.

By comparing these two treatment approaches, the researchers hope to learn if the combination can help people live longer, or keep their cancer from growing for a longer period. They will also carefully watch for any side effects to make sure the treatment is safe. Studies like this are crucial for developing new and improved ways to care for people with advanced lung cancer.

Key takeaways

This study compares a new combined lung cancer treatment to a standard one.
It's for specific advanced non-small cell lung cancer patients who haven't had prior treatment.
The new treatment involves Dato-DXd and pembrolizumab.
The study aims to see if the combination works better for controlling cancer growth and survival.
You'll be closely monitored for effectiveness and side effects.
Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old, with non-small cell lung cancer that is advanced or has spread. Your lung cancer needs to be of a specific type (non-squamous histology). Also, doctors will check if your cancer has certain genetic changes (called mutations) that are already known to respond to other specific treatments. For this study, your cancer shouldn't have these known changes, though having a KRAS mutation is okay.

Your cancer also needs to have a high level of a specific protein called PD-L1. This study is for people who haven't had any previous treatment for their advanced lung cancer. Before you can join, you'll need to sign consent forms and have some checks to make sure your cancer fits the study's specific requirements, including providing a tissue sample for testing.

Quick self-check

Are you 18 years old or older?
Do you have advanced or metastatic non-small cell lung cancer of the non-squamous type?
Has your cancer started to spread, or is it too advanced for surgery/radiation to cure?
Has your doctor confirmed your cancer has high levels of a protein called PD-L1?
Have you NOT received any prior treatment for your advanced lung cancer?
Does your cancer NOT have common genetic changes (like EGFR, ALK, ROS1) that have specific approved treatments?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will first go through a screening period to make sure you're a good fit. This involves checks like blood tests and scans, and signing consent forms. Then, you'll be randomly assigned to one of two groups: one group will receive Dato-DXd along with pembrolizumab, and the other group will receive pembrolizumab alone. You won't get to choose which group you're in – it's like flipping a coin to make it fair.

You will receive your assigned treatment over a period of time, with regular visits to the clinic for medical examinations, blood tests, and scans to see how you're responding to the treatment and to check for any side effects. After your treatment period, there will be a follow-up period to continue monitoring your health and the long-term effects of the treatment. The total duration of your participation will depend on how you respond to the treatment and the follow-up schedule.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access new treatments that aren't yet widely available, which might be more effective for your cancer. However, there's no guarantee that the treatment will work for you, and it may not be better than standard treatments. Like all medicines, the study drugs can have side effects, which might be mild or more serious. The study team will monitor you closely for any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (243)

Ironwood Cancer and Research Center
Chandler, United States· Recruiting
UCLA HemOnc - Clinical Research Unit
Los Angeles, United States· Recruiting
Compassionate Cancer Care Medical Group
Riverside, United States· Withdrawn
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, United States· Withdrawn
Ridley-Tree Cancer Center
Santa Barbara, United States· Recruiting
PIH Health Whittier Hospital
Whittier, United States· Recruiting
The Oncology Institute of Hope and Innovation
Whittier, United States· Terminated
Uch-Mhs D/B/A Memorial Health System
Colorado Springs, United States· Recruiting
Johns Hopkins University
Baltimore, United States· Recruiting
American Oncology Partners of Maryland
Bethesda, United States· Recruiting
Dana-Farber Cancer Institute
Boston, United States· Recruiting
Beth Israel Deaconess Medical Center
Boston, United States· Recruiting

+231 more sites — see the official record for the full list.

Common questions

What is non-small cell lung cancer?

It's the most common type of lung cancer. This study is for a specific kind called non-squamous NSCLC.

What does 'advanced or metastatic' mean?

It means the cancer has either grown locally in the chest to a significant stage, or has spread from the lung to other parts of the body.

What is PD-L1 and why is it important?

PD-L1 is a protein found on cancer cells. High levels of PD-L1 can mean that specific types of immunotherapy, like pembrolizumab, might be more effective.

Will I know which treatment group I'm in?

No, it's a 'blinded' study where you won't know if you're getting the combination treatment or pembrolizumab alone. This helps make the study results fair.

Are there any costs for me to participate?

Generally, study-related treatments and tests are covered by the study sponsor. You should discuss any potential personal costs, like travel, with the study team.

How to find out more

(US Sites) Daiichi Sankyo Contact for Clinical Trial Information

CTRinfo@dsi.com 908-992-6400 Official trial record

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