Active not recruitingPHASE3INTERVENTIONAL

Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)

This research trial is for people with a type of advanced lung cancer called non-small cell lung cancer, who haven't had previous treatment for it. The study wants to find out if new drug combinations are safer and more effective than a standard treatment. We are comparing different treatment plans: one involves a new drug called Datopotamab Deruxtecan (Dato-DXd) combined with Pembrolizumab and chemotherapy. Another plan uses Dato-DXd and Pembrolizumab without chemotherapy. These are both compared to the current standard treatment, which uses Pembrolizumab with two types of chemotherapy. The main goal is to see if these new combinations can stop the cancer from growing for longer and help people live longer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Daiichi Sankyo

Enrolment target

1,170

Start

11 Jan 2023

Estimated completion

11 May 2029

Metastatic Non Small Cell Lung Cancer

What is this study about?

This study is for adults who have advanced non-small cell lung cancer, a common type of lung cancer, and who haven't received medication for it before. When cancer is 'advanced' or 'metastatic,' it means it has spread from where it started to other parts of the body.

The main aim of this research is to see if a new drug, Datopotamab Deruxtecan, when given with another drug called Pembrolizumab, works better and is safer than standard chemotherapy combined with Pembrolizumab. We want to find out if these newer combinations can stop the cancer from getting worse for longer and help people live longer overall. The doctors will also be keeping a close eye on any side effects to make sure the treatments are as safe as possible.

Participants will be put into three different groups by chance (like flipping a coin). One group will get the new drug combination with chemotherapy, another will get it without chemotherapy, and the third group will receive the standard treatment. This allows the researchers to fairly compare the different approaches and see which one is most helpful for patients.

Key takeaways

This study is for untreated advanced non-small cell lung cancer.
It compares new drug combinations with standard treatment.
The goal is to find better and safer ways to treat this cancer.
Participants will be randomly assigned to one of three treatment groups.
Regular health checks and monitoring for side effects are part of the study.
You can stop participating at any time.

Who may be eligible?

This study is for adults aged 18 or older. To join, you must have advanced non-small cell lung cancer that hasn't been treated with medication before. Your cancer cells must have a specific protein called PD-L1 at a low level (less than 50%), and you shouldn't have certain genetic changes in your cancer that would make other specific treatments more suitable for you.

Doctors will need to look at a small sample of your tumor tissue to check for these factors. You must also be able to come to all scheduled appointments and follow the study instructions carefully. You should have measurable cancer that can be seen on scans.

Some things might mean you can't join the study, such as having already received treatment for advanced lung cancer. The research team will carefully review your medical history to make sure this study is right for you.

Quick self-check

Are you 18 years old or older?
Do you have advanced non-small cell lung cancer that hasn't been treated with medication before?
Has your doctor confirmed your cancer has low levels of a protein called PD-L1?
Are you willing and able to attend regular appointments and follow study instructions?
Are you able to provide a small sample of your tumor tissue?

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, you'll first have a 'Screening Period' where doctors will check if you're suitable for the study. This includes giving a small sample of your tumor tissue and having various tests. If you qualify, you'll be randomly assigned to one of three treatment groups. This is like drawing names out of a hat – it's by chance.

You'll then enter the 'Treatment Period,' where you'll receive your assigned medications. This will involve regular visits to the clinic for your treatment and to monitor your health and any side effects. After the treatment period ends, there will be a 'Follow-up Period' where the study team will continue to check on your health and any long-term effects. The total duration of your participation will depend on how you respond to treatment and other factors, but the team will explain this fully to you.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and risks. You might benefit from receiving a new treatment that isn't widely available yet, which could be more effective than existing options. However, there's no guarantee the treatment will work for you, and it might not be better than standard care. All medications have potential side effects, and the study doctors will carefully explain the known risks of the treatments involved. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (254)

Southern Cancer Center Pc
Daphne, United States
Ironwood Cancer and Research Centers
Chandler, United States
Arizona Oncology Associates, Pc - Nahoa
Prescott Valley, United States
Hoag Memorial Hospital Prebyterian
Newport Beach, United States
Compassionate Cancer Care Medical Group
Riverside, United States
Sansum Clinic
Santa Barbara, United States
Ronald Reagan UCLA Medical Center
Santa Monica, United States
UCHealth Memorial Hospital
Colorado Springs, United States
Florida Cancer Specialists - South
Fort Myers, United States
Cancer Specialist of North Florida
Jacksonville, United States
Cancer Care Centers of Brevard, Inc.
Palm Bay, United States
Woodlands Medical Specialists, Pa
Pensacola, United States

+242 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, and this study focuses on when it has spread to other parts of the body.

What do 'Datopotamab Deruxtecan' and 'Pembrolizumab' do?

These are names of drugs. Datopotamab Deruxtecan is a new drug being tested, and Pembrolizumab is an immunotherapy drug that helps your immune system fight cancer.

Will I definitely get the new drug?

You'll be randomly assigned to one of three groups. Two groups will receive the new drug combination, and one will receive the standard treatment.

How long will the study last for me?

The study has screening, treatment, and follow-up periods. The exact duration for you will depend on your response but will be explained by the study team.

What if I change my mind about participating?

You can leave the study at any time, for any reason, and it won't affect your future medical care.