Active not recruitingPHASE2INTERVENTIONAL

Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)

This research is a Phase 2 clinical trial exploring new ways to treat advanced or metastatic non-small cell lung cancer (NSCLC). This means the cancer has spread from where it started. The main goal is to understand more about a new drug called sacituzumab govitecan (SG) and find the best way to give it in combination with other common cancer treatments. Researchers are testing SG with pembrolizumab, and sometimes adding chemotherapy drugs like carboplatin or cisplatin. The study aims to see how safe and effective these new combinations are for people with this type of lung cancer who haven't had previous treatment for advanced disease. This will help doctors decide on the best future treatments.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Gilead Sciences

Enrolment target

193

Start

30 May 2022

Estimated completion

01 Sep 2026

Non-small Cell Lung Cancer

What is this study about?

When cancer has grown or spread to other parts of the body, it's called advanced or metastatic cancer. For certain types of lung cancer, specifically non-small cell lung cancer (NSCLC), doctors are always looking for better treatments. This study focuses on people who have advanced NSCLC that hasn't been treated yet with medications for its advanced stage.

The main drug being looked at is called sacituzumab govitecan, or SG for short. It's a type of targeted therapy designed to find and attack cancer cells. Researchers want to see how SG works when given along with another common cancer medicine called pembrolizumab, which helps your body's immune system fight cancer. In some cases, the study will also include traditional chemotherapy drugs like carboplatin or cisplatin, given alongside SG and pembrolizumab.

The aim is to understand how well these combinations work together, how safe they are, and if they can help improve the treatment for people with advanced NSCLC. This kind of research is really important because it helps doctors find new and more effective ways to fight cancer in the future.

Key takeaways

This study is for advanced non-small cell lung cancer that has spread.
It tests new combinations of modern cancer drugs and chemotherapy.
Participants must not have had prior treatment for advanced lung cancer.
Regular hospital visits and health checks will be part of the study.
You can stop participating at any time if you change your mind.

Who may be eligible?

To be considered for this study, you would need to have been diagnosed with a specific type of advanced non-small cell lung cancer that has spread. You also can't have had any medication treatment for your advanced lung cancer already. Doctors would need to be able to measure your cancer on scans like CT or MRI.

There are also some general health requirements. For example, your organs like your liver need to be working well, and your blood tests should be within a healthy range. You'd also need to be generally well enough to take part in the study, meaning you're able to carry out most of your daily activities.

However, there are reasons why you might not be able to join. For instance, if you have other serious health problems like active autoimmune diseases, certain heart conditions, or uncontrolled infections. If you've had certain other cancers recently, or if you're pregnant or breastfeeding, you also wouldn't be able to participate. Also, if you've recently had major radiation treatment to your lungs or certain allergies to the study medications, you wouldn't be eligible.

Quick self-check

Do I have advanced non-small cell lung cancer that has spread?
Have I received previous medication treatment for my advanced lung cancer?
Are my general health and organ functions, like liver and blood, generally good?
Do I have serious active health conditions like certain heart problems or autoimmune diseases?
Am I pregnant or breastfeeding?

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 receive one of the study drug combinations. This will involve regular visits to the hospital for treatments, usually given intravenously (through a drip in your arm). These visits will also include various tests, such as blood tests, physical examinations, and scans (like CT or MRI) to monitor how you're responding to the treatment and to check for any side effects. You'll have close follow-up with the study team throughout the treatment period.

The total duration of your participation will depend on how you respond to the treatment and the study plan. You will continue treatment for as long as it is helping you and is safe to take, or until the study ends. After stopping treatment, there will be a follow-up period where you'll have occasional check-ups to monitor your health and any long-term effects.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and potential risks. A potential benefit could be access to new treatments that are not yet widely available, which might help control your cancer. However, there's no guarantee the treatment will work for you. Potential risks include side effects from the study drugs, which can vary from mild to severe, similar to any cancer treatment. These will be fully explained by the study team. You are free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (101)

Alaska Oncology and Hematology, LLC.
Anchorage, United States
Beverly Hills Cancer Center
Beverly Hills, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, United States
UCLA Hematology/Oncology - Santa Monica
Los Angeles, United States
UC Irvine Health
Orange, United States
Stanford Cancer Institute
Stanford, United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, United States
Georgetown University Medical Center
Washington D.C., United States
Moffitt Cancer Center
Tampa, United States
Northside Hospital Central Research Department
Atlanta, United States
Northwestern Memorial Hospital
Chicago, United States
Rush University Medical Center
Chicago, United States

+89 more sites — see the official record for the full list.

Common questions

What is 'advanced or metastatic NSCLC'?

This means lung cancer that has grown beyond its original site or has spread to other parts of your body.

What is Sacituzumab Govitecan (SG)?

SG is a newer type of cancer medicine, sometimes called an 'antibody-drug conjugate,' designed to specifically target and kill cancer cells.

What is a 'Phase 2' study?

A Phase 2 study is a stage of research that explores if a new treatment is effective and safe for specific conditions, usually involving a larger group of patients than earlier studies.

Will I receive chemotherapy?

Some people in this study will receive chemotherapy drugs like carboplatin or cisplatin along with the other study medications, while others may not. The study team will explain your specific treatment plan.

What if I have side effects?

The study team will carefully monitor you for any side effects throughout the trial and provide support and care to manage them.