Active not recruitingPHASE3INTERVENTIONAL

Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)

This research study is looking at a new treatment called DS-1062a for people with advanced or metastatic non-small cell lung cancer. This is a type of lung cancer that has spread or is difficult to treat. The study aims to see if DS-1062a works better and is safer than a standard chemotherapy drug, docetaxel. It's for patients who have already had other treatments, and whose cancer has continued to grow. Some people will have specific gene changes in their cancer, and others won't. By joining, you could help doctors understand if this new drug could be a future option for lung cancer patients.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Daiichi Sankyo

Enrolment target

605

Start

21 Dec 2020

Estimated completion

15 Feb 2027

Non-small Cell Lung Cancer

What is this study about?

This study is investigating a new medication called DS-1062a. It's designed for people who have advanced or metastatic non-small cell lung cancer, which means the cancer has spread beyond the lung where it started. We know that finding effective treatments for this stage of cancer is really important, especially when previous treatments haven't completely stopped the cancer from growing.

In this study, DS-1062a will be compared to a well-known chemotherapy drug called docetaxel. This comparison is vital because it helps doctors understand if the new drug offers a better option, perhaps by being more effective, having fewer side effects, or a combination of both. The study also looks at whether the presence or absence of certain genetic changes in the cancer cells affects how well the treatment works.

Taking part in a study like this helps advance medical science and could lead to new treatments becoming available for more people in the future. It's a chance to potentially access a new treatment while contributing to our understanding of lung cancer and how to fight it.

Key takeaways

This study compares a new drug (DS-1062a) with standard chemotherapy (docetaxel) for advanced lung cancer.
It's for people whose cancer has already been treated and has shown progression.
Your cancer may or may not have specific genetic changes.
Participation involves regular hospital visits for treatment, tests, and monitoring.
You can stop participating at any time.
This research could help develop new future treatments for lung cancer.

Who may be eligible?

To join this study, you need to be an adult aged 18 or over with a life expectancy of at least 3 months. You must have advanced or metastatic non-small cell lung cancer (Stage IIIB, IIIC, or IV) that has been previously treated and has since shown signs of getting worse (progressed).

If your cancer doesn't have certain genetic changes, you must have already had specific chemotherapy (platinum-based) and a particular type of immunotherapy (PD-1/PD-L1 antibody treatment). If your cancer *does* have specific genetic changes (like EGFR, ALK, or others), you must have had one platinum-based chemotherapy and one to two targeted therapies for those changes, and your cancer must have progressed after these treatments.

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 old or older with at least 3 months life expectancy?
Do you have advanced or metastatic non-small cell lung cancer?
Has your cancer been previously treated and has it shown signs of getting worse?
If your cancer has specific gene changes, have you had one platinum chemotherapy and 1-2 targeted therapies?
If your cancer *doesn't* have specific gene changes, have you had platinum chemotherapy and specific immunotherapy?
Are you willing to sign a consent form?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve different stages. First, there's a screening period to make sure you meet all the requirements. If you do, you'll then enter the treatment period where you'll receive either DS-1062a or docetaxel. These treatments will be given over a period, and you'll have regular hospital visits for blood tests, scans, and check-ups to monitor how you're doing and if the treatment is working. After the treatment period, there will be a follow-up period to continue monitoring your health for a longer time. The total duration of your involvement isn't specified but will involve several visits over an extended period.

Potential risks and benefits

Participating in this study might offer you access to a new treatment (DS-1062a) investigational drug that might be more effective than standard treatment. However, like all medications, both DS-1062a and docetaxel can have side effects, which can vary from mild to severe, and they will be carefully monitored. There's also no guarantee the treatment will work for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (209)

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

Ironwood Cancer and Research Center
Verified postcode
Chandler, United States
St. Joseph Heritage Healthcare
Verified postcode
Anaheim, United States
The Oncology Institute of Hope and Innovation
Verified postcode
Glendale, United States
University of California San Diego
Verified postcode
La Jolla, United States
UCLA
Verified postcode
Los Angeles, United States
PIH Health
Verified postcode
Whittier, United States
Memorial Healthcare System- Memorial Cancer Institute
Verified postcode
Hollywood, United States
Orlando Health
Verified postcode
Orlando, United States
Florida Cancer Specialists
Verified postcode
Tallahassee, United States
Northwestern University
Verified postcode
Chicago, United States
University of Chicago
Verified postcode
Chicago, United States
Ft. Wayne Medical Oncology and Hematology
Verified postcode
Fort Wayne, United States

Common questions

What is Non-small Cell Lung Cancer?

It's the most common type of lung cancer. 'Advanced' or 'metastatic' means the cancer has spread to other parts of the body.

What are 'actionable genomic alterations'?

These are specific changes in the cancer's genes that can sometimes be targeted with certain medications. Some people's cancers have them, and some don't.

What is DS-1062a?

It's a new, experimental drug that is being tested to see how well it works against lung cancer compared to existing treatments.

What is Docetaxel?

Docetaxel is a standard chemotherapy drug that is already used to treat various types of cancer, including lung cancer.

Will I know which treatment I get?

In this type of study, often participants are randomly assigned to one treatment or the other, and sometimes neither you nor your doctor will know which one you are receiving during the study, to ensure fairness and accuracy of results.