Active not recruitingPHASE2INTERVENTIONAL

Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer

This study is testing a new medicine called DS-1062a for people with a type of lung cancer called non-small cell lung cancer (NSCLC) that has spread or can't be operated on. Participants in this study will have already tried one to three other standard treatments that haven't worked well enough. The main goals are to find out if DS-1062a is effective at shrinking or controlling the cancer and if it's safe. We'll also be looking at how the drug works in the body, why some people respond better than others, and how it affects cancer cells. Around 100 people will take part.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Enrolment target

100

Start

12 May 2021

Estimated completion

01 Sep 2028

Metastatic Lung Cancer Advanced Non Small Cell Lung Cancer Unresectable Non-small Lung Cancer

What is this study about?

This study is exploring a new treatment, DS-1062a, for adults diagnosed with advanced non-small cell lung cancer (NSCLC). This means the cancer has either spread to other parts of the body (metastatic) or cannot be removed through surgery (unresectable). We're particularly interested in patients who have already received one to three different standard treatments, but these treatments haven't been successful enough, or there are no other standard options available for them.

The main aim is to understand two key things: first, how well DS-1062a works to fight the cancer, and second, whether it is safe for patients to use. We also want to learn more about how the drug affects the body and the cancer itself, including why some people respond better than others. This will help us identify who might benefit most from this new treatment in the future. We'll also be checking how the drug moves through the body and if the body develops antibodies against it.

Around 100 people are expected to join this study. They will receive the study drug every three weeks. Regular check-ups, scans, and blood tests will be part of the study plan to monitor their health and the cancer's progress. This research is important because it could lead to new treatment options for a type of lung cancer that can be very challenging to treat.

Key takeaways

Tests a new drug (DS-1062a) for advanced lung cancer.
For patients who have tried 1-3 previous treatments.
Aims to check drug effectiveness and safety.
Treatment given every three weeks, with regular scans and checks.
Around 100 patients expected to join.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you must have been diagnosed with advanced non-small cell lung cancer (NSCLC) that has spread or can't be removed by surgery. You also need to have tried at least one, but not more than three, previous standard treatments for your cancer that haven't worked as hoped, or for which there are no other standard options.

Depending on the specific characteristics of your cancer cells (like certain genetic changes), the type of previous treatments required might vary. For instance, if your cancer has specific gene changes (like EGFR, BRAF, MET, ALK, ROS1, RET, NTRK), you should have already received a targeted therapy and a platinum-based chemotherapy. If your cancer doesn't have these specific changes, you should have received immunotherapy and a platinum-based chemotherapy.

You also need to be at least 18 years old, generally well enough to participate (meaning you can mostly look after yourself), and have a life expectancy of at least three months. Your body should also be healthy enough to handle the treatment, which will be checked through blood tests. If you have brain or bone cancer that has spread, it needs to be stable and not causing significant symptoms. Women who could become pregnant must use effective birth control during and for several months after the study.

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.

I have advanced non-small cell lung cancer (NSCLC) that has spread or can't be removed by surgery.
I have already tried between one and three other standard cancer treatments.
I am at least 18 years old and generally feel well enough to manage my daily activities.
My doctors believe I have at least 3 months life expectancy.
My blood tests show my body and organs are working well enough.
If I am a woman who could get pregnant, I am willing to use effective birth control during and after the study.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medicine, DS-1062a, once every three weeks. This treatment will continue as long as the medicine is helping you and you are not experiencing severe side effects. The amount of medicine you receive will be based on your body weight.

To keep track of your health and how the treatment is working, you'll have regular appointments. Every six weeks, you'll have scans like CT scans or MRI scans to check your cancer. If your cancer has spread to your brain or bones, you might have specific scans for those areas too. We'll also perform complete health checks, blood tests, heart checks like ECGs (electrocardiograms) and ECHOs (heart scans) to make sure the treatment is safe for you. We'll also ask you about any side effects you might experience. The total duration of your participation will depend on how you respond to the treatment and your health.

Potential risks and benefits

Participating in this study might offer a potential benefit by giving you access to a new treatment that isn't yet widely available. While we hope DS-1062a will help control your cancer, there's no guarantee it will work for everyone, and it might not be more effective than other treatments. Like all medicines, DS-1062a could have side effects, which will be closely monitored through regular tests and checks. We will explain all known or expected risks to you before you decide to join. It is your right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (9)

Institut Bergonié
Verified postcode
Bordeaux, France
Institut de Cancérologie, CHRU Morvan de Brest
Verified postcode
Brest, France
Centre François Baclesse
Verified postcode
Caen, France
Centre Hospitalier Intercommunal de Créteil
Verified postcode
Créteil, France
Hôpital Cochin
Verified postcode
Paris, France
Hôpital Tenon
Verified postcode
Paris, France
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
Verified postcode
Pierre-Bénite, France
Hôpitaux Universitaires de Strasbourg
Verified postcode
Strasbourg, France
Gustave Roussy
Verified postcode
Villejuif, France

Common questions

What kind of cancer is this study for?

This study is for people with advanced non-small cell lung cancer (NSCLC) that has either spread or cannot be removed by surgery.

What is DS-1062a?

DS-1062a is a new experimental drug being tested to see how well it works and if it's safe for treating this type of lung cancer.

How often will I receive the treatment?

You will receive the study treatment once every three weeks, as long as it's helping you and you're not having serious side effects.

What if I decide I don't want to be in the study anymore?

You can leave the study at any time, for any reason. This will not affect your regular medical care.

Will this drug cure my cancer?

This is a research study to see if DS-1062a can help control or shrink the cancer. We cannot promise a cure.