Active not recruitingPHASE3INTERVENTIONAL

A Study of SGN-B6A Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer

This study is for people with advanced non-small cell lung cancer that has already been treated with other medicines. Researchers want to compare a new drug, sigvotatug vedotin, with a standard cancer treatment called docetaxel. Sigvotatug vedotin is a targeted drug designed to find and kill cancer cells. Participants will either receive the new drug on specific days over a 28-day cycle, or docetaxel on one day of a 21-day cycle. The main goal is to find out if sigvotatug vedotin is more effective than docetaxel and to understand its side effects. This research helps improve future cancer treatments.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Enrolment target

762

Start

21 Feb 2024

Estimated completion

17 May 2028

Carcinoma, Non-Small-Cell Lung

What is this study about?

This clinical trial is looking into a type of lung cancer called non-small cell lung cancer (NSCLC) that has either spread to other parts of the body or cannot be removed by surgery. This study is specifically for people who have already had some treatment for their cancer, such as certain chemotherapy and immunotherapy drugs.

The trial is testing an experimental drug named sigvotatug vedotin. This drug is a special kind of medicine called an 'antibody-drug conjugate' (ADC). Think of it like a smart bomb: it's designed to stick directly to cancer cells and then release a powerful medicine to kill them, hopefully causing less harm to healthy cells. The study is comparing this new drug to docetaxel, which is a standard chemotherapy drug already approved and used for NSCLC when other treatments haven't worked or are no longer effective.

The main purpose of this study is to see if sigvotatug vedotin is a better treatment option than docetaxel for people with NSCLC. Researchers will closely watch to see how well each drug works in shrinking or controlling the cancer, and also carefully record any side effects that people experience. Understanding the safety and effectiveness of new treatments like sigvotatug vedotin is crucial for improving care for those affected by lung cancer.

Key takeaways

Targets advanced non-small cell lung cancer (non-squamous type).
Compares a new drug (sigvotatug vedotin) to an existing treatment (docetaxel).
For patients who have already received specific prior cancer treatments.
Aims to find out if the new drug works better and what its side effects are.
Participation involves receiving treatment and regular medical check-ups.
You can discuss potential benefits and risks with the study team before deciding.

Who may be eligible?

This study is for adults aged 18 or over who have non-small cell lung cancer that has spread or cannot be removed by surgery. Your cancer must be a specific type called 'non-squamous' NSCLC, based on how the cancer cells look under a microscope.

You must have already received certain prior treatments for your lung cancer. This typically includes a platinum-based chemotherapy and an anti-PD-(L)1 drug (a type of immunotherapy). If your cancer has specific gene changes that can be treated, you must have also received at least one drug targeting that specific change, in addition to the other treatments.

It's important that your cancer has either progressed during or after your most recent treatment. There are also other health requirements that the study doctors will check to make sure the trial is safe and suitable for you.

Quick self-check

Are you 18 years old or older?
Do you have advanced 'non-squamous' non-small cell lung cancer?
Have you already received platinum-based chemotherapy and an anti-PD-(L)1 drug?
If your cancer has specific treatable gene changes, have you already received a drug for that change?
Has your cancer progressed during or after your most recent treatment?

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

What does participation involve?

If you join this study, you will be assigned to one of two groups by chance, like flipping a coin. One group will receive the new drug, sigvotatug vedotin, given through a drip on day 1 and day 15 of every 28-day cycle. The other group will receive docetaxel, also given through a drip, on day 1 of every 21-day cycle. The treatment will continue as long as it benefits you and you tolerate it well, or until your cancer worsens.

Throughout the study, you will have regular visits to the clinic for treatments, check-ups, blood tests, and scans to monitor your cancer and check for any side effects. These visits might include detailed examinations. The healthcare team will explain your specific schedule of appointments, which will be frequent initially and then become less often over time.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to a new experimental drug that might be more effective than standard treatments. However, there are also potential risks, including unknown side effects of the experimental drug, or that the new drug may not work as well as expected. All drugs have side effects, and the study will carefully monitor these. You will be fully informed about all known risks and benefits before deciding to join, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (334)

Alaska Oncology and Hematology, LLC
Anchorage, United States
Providence Medical Foundation
Fullerton, United States
Providence St. Jude Medical Center Virginia K. Crosson Cancer Center and Infusion Center
Fullerton, United States
Providence St. Jude Medical Center
Fullerton, United States
Cancer and Blood Specialty Clinic
Los Alamitos, United States
Cancer Blood and Specialty Clinic
Los Alamitos, United States
Regulatory Management Only: TRIO-US Central Administration
Los Angeles, United States
Drug Management Only: UCLA West Medical Pharmacy Attn: Steven L. Wong, Pharma.D.
Los Angeles, United States
Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D.
Los Angeles, United States
UCSF Medical Center - Mission Bay
San Francisco, United States
Sansum Clinic
Santa Barbara, United States
Sansum Clinic
Solvang, United States

+322 more sites — see the official record for the full list.

Common questions

What type of lung cancer is this study for?

This study is for advanced non-small cell lung cancer (NSCLC) that is specifically of the 'non-squamous' type and has already been treated.

What are the treatments being tested?

The study is comparing a new experimental drug called sigvotatug vedotin with a standard cancer medicine, docetaxel.

Do I have to have had previous cancer treatment to join?

Yes, you must have already received certain types of treatment for your lung cancer, including specific chemotherapy and immunotherapy drugs.

What is sigvotatug vedotin?

It's a new type of targeted drug called an antibody-drug conjugate (ADC), designed to specifically find and kill cancer cells.

How long will the treatment last?

Treatment will continue for as long as it helps you and you tolerate it well, or until your cancer gets worse.