Active not recruitingPHASE3INTERVENTIONAL

Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

This study is looking into a new treatment called Sacituzumab Govitecan (SG) for people in the UK who have advanced or spread non-small cell lung cancer. This type of lung cancer has already been treated with certain other medications, but those treatments haven't worked well enough. The study aims to see if SG is more effective or safer than a standard chemotherapy drug called Docetaxel. By comparing these two treatments, researchers hope to find a better way to help patients whose cancer has progressed. This is a Phase 3 study, which means it's a large trial to confirm the drug's effectiveness and safety before it can be widely used.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Gilead Sciences

Enrolment target

603

Start

17 Nov 2021

Estimated completion

01 Jan 2027

Non-Small Cell Lung Cancer

What is this study about?

This study is about finding better treatments for a type of lung cancer called non-small cell lung cancer. When cancer is "advanced" or "metastatic," it means it has spread from where it started to other parts of the body. This study focuses on people whose cancer has already been treated with standard chemotherapy and immunotherapy, but these treatments haven't stopped the cancer from growing.

The researchers want to compare a new drug called Sacituzumab Govitecan (SG) with a commonly used chemotherapy drug called Docetaxel. They want to see which treatment works best at shrinking the cancer, slowing its growth, and helping people feel better and live longer. By doing this comparison, they can learn if SG could be a new and better option for patients who have limited choices after their initial treatments.

Taking part in a study like this is a way to access new treatments that aren't yet widely available. It also helps doctors learn more about cancer and how to fight it. Every step of the study is carefully planned and monitored by medical experts to ensure patient safety.

Key takeaways

This study compares a new lung cancer drug with a standard one.
It's for people with advanced non-small cell lung cancer that has spread.
Participants have already tried other treatments that didn't work well enough.
The aim is to find out if the new drug is more effective or safer.
You would receive either the new drug or a standard chemotherapy.
Taking part helps advance cancer knowledge and treatment options.

Who may be eligible?

To join this study, you would need to have non-small cell lung cancer that has spread to other parts of your body. Your doctors would need to confirm this with tests. You would also have already received specific treatments for your cancer, including chemotherapy and a type of immunotherapy, and your cancer would need to have started growing again after these treatments.

In some cases, if your cancer has certain genetic changes (like EGFR or ALK), you would also need to have received treatment for those specific changes. Before starting, your general health would be checked to make sure you're well enough to take part, including blood tests and a check of your daily activity level. You must be at least 18 years old.

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.

Do you have non-small cell lung cancer that has spread?
Have you already had chemotherapy and immunotherapy for your cancer, and it has progressed?
Are you at least 18 years old?
Are you generally well enough for treatment, as assessed by your doctor and blood tests?
Do you have measurable cancer that can be seen on scans (like CT or MRI)?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive either the new drug, Sacituzumab Govitecan, or the standard drug, Docetaxel. You wouldn't get to choose which one you receive; it's decided by chance, like flipping a coin. You would have regular visits to the hospital or clinic for your treatment and check-ups. These visits would include blood tests, scans (like CT or MRI) to see how your cancer is responding, and discussions with the study doctors and nurses about how you're feeling.

The treatments would likely be given as an infusion (through a drip) into your vein. The length of time you receive treatment would depend on how well you tolerate it and how your cancer responds. You would be closely monitored throughout the study, and even after you stop treatment, there would be follow-up calls or visits to see how you are doing. The total duration of your involvement could be several months or longer, depending on your individual response.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you might receive a new treatment that could be more effective than current options for your type of cancer. It could also help improve understanding of how to treat advanced lung cancer for future patients. However, there's no guarantee the new treatment will be better for you, and like all medications, both the study drug and Docetaxel have potential side effects. These can vary from mild to severe, and the study team will carefully monitor you for any problems. You will be given full information about these risks before deciding to join. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (227)

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

Alaska Oncology and Hematology, LLC.
Verified postcode
Anchorage, United States
USOR - Arizona Oncology Associates Tucson - Wilmot
Verified postcode
Tucson, United States
Beverly Hills Cancer Center
Verified postcode
Beverly Hills, United States
Rocky Mountain Cancer Centers - Aurora
Verified postcode
Aurora, United States
Florida Cancer Specialists (Administration and Drug Shipment)
Verified postcode
Fort Myers, United States
Woodlands Medical Specialists, PA
Verified postcode
Pensacola, United States
Florida Cancer Specialists
Verified postcode
St. Petersburg, United States
Florida Cancer Specialists
Verified postcode
West Palm Beach, United States
University of Chicago Medical Center
Verified postcode
Chicago, United States
Illinois Cancer Specialists
Verified postcode
Niles, United States
Siouxland Regional Cancer Center dba June E. Nylen Cancer Center
Verified postcode
Sioux City, United States
Kansas City VA Medical Center
Verified postcode
Westwood, United States

Common questions

What is Sacituzumab Govitecan?

It's a new investigational drug that attaches to cancer cells and delivers medicine directly to them, aiming to kill them more effectively.

What is Non-Small Cell Lung Cancer?

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

Will I know if I'm getting the new drug or the standard one?

No, this is a 'blinded' study, meaning neither you nor your study doctor will know which treatment you are receiving until after the study is over, or if there's a medical reason to find out.

What happens if the treatment doesn't work for me?

Your doctors will regularly check how you're responding. If the treatment isn't helping or if side effects become too difficult, you'll stop the study drug, and your medical team will discuss other care options with you.

Does it cost anything to be in the study?

No, you will not have to pay for the study drugs or any research-related tests and procedures. You might be reimbursed for travel costs to appointments.