Active not recruitingPHASE3INTERVENTIONAL

A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer

This important study is for people with extensive-stage small-cell lung cancer (ES-SCLC), a type of advanced lung cancer. Participants first receive a standard initial treatment involving carboplatin, etoposide, and atezolizumab. If their cancer responds well or stays stable after this initial stage, they may then be invited to join the main part of the study. In this second stage, they will either receive atezolizumab alone or atezolizumab combined with another medicine called lurbinectedin. The study aims to find out if adding lurbinectedin helps keep the cancer in check for longer. It's designed to see which maintenance treatment is more effective after initial therapy for this type of lung cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

660

Start

18 Nov 2021

Estimated completion

13 Aug 2026

Small-Cell Lung Cancer

What is this study about?

This study is investigating a new approach to treating extensive-stage small-cell lung cancer (ES-SCLC), which is a type of lung cancer that has spread. The main goal is to find out if combining two medicines, atezolizumab and lurbinectedin, works better than atezolizumab alone to keep the cancer stable after initial treatment.

Think of the study in two main parts. In the first part, all participants receive a standard initial treatment for their cancer, which includes carboplatin, etoposide, and atezolizumab. This initial treatment is given to try and get the cancer under control. Doctors will then check how well the cancer has responded.

If your cancer has responded positively or remained stable after this initial treatment, you might be invited to continue into the second part of the study. This is where the new comparison happens. You would be randomly assigned to one of two groups: one group receives atezolizumab on its own, and the other group receives atezolizumab together with lurbinectedin. The study wants to see if this combination therapy can help people live longer or keep their cancer from getting worse, compared to atezolizumab alone.

Key takeaways

It's for people with advanced small-cell lung cancer.
It tests two different 'maintenance' treatments after initial chemotherapy.
One group gets atezolizumab, the other gets atezolizumab plus lurbinectedin.
Participation is voluntary, and you can withdraw at any time.
This is an 'open-label' study, so you will know which treatment you are receiving.

Who may be eligible?

This study is for adults aged 18 or over with a specific type of advanced small-cell lung cancer. To be considered, you should not have received any previous treatment for this advanced lung cancer. Your general health and organ function need to be good, and your doctors must be able to measure your cancer on scans.

There are also some reasons why you wouldn't be able to join. For example, if your cancer has spread to your brain or spinal cord, if you have certain autoimmune diseases, or if you've had other cancers recently. Also, if you've previously received similar types of immunotherapy or certain other drugs, you might not be eligible. If you have serious lung conditions or active infections, you might not be able to participate either.

For those who do well on the initial treatment, there are further criteria for the second part of the study. Your cancer needs to be stable or have shrunk, and any side effects from the first treatment must have largely cleared up. Again, your overall health and organ function must remain good.

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 or older?
Do you have extensive-stage small-cell lung cancer?
Have you not had previous treatment for this type of advanced lung cancer?
Is your general health good enough for cancer treatment?
Do you have no active brain metastases?
Do you not have certain serious autoimmune diseases?

Answer every question to see your result.

What does participation involve?

If you join this study, it involves two main phases. In the first phase, you will receive standard initial chemotherapy and immunotherapy (carboplatin, etoposide, and atezolizumab) over approximately 12 weeks. During this time, you'll have regular hospital visits for treatments, blood tests, and scans to monitor your health and how your cancer is responding.

If your cancer responds well or stays stable after this first phase, you may then be invited to enter the second phase. In this phase, you'll be randomly assigned to receive either atezolizumab alone or atezolizumab combined with lurbinectedin. This treatment continues for as long as it is working and you are tolerating it well. You will continue to have regular hospital visits for treatments, check-ups, and scans to monitor your progress and watch for any side effects. The total duration of your participation would depend on how your cancer responds to the treatment.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as accessing new treatments that are not yet widely available. However, there's no guarantee that the study treatment will be effective for you. Like all medicines, the treatments in this study can have side effects, which your medical team will discuss with you. You will be closely monitored for any unwanted effects throughout the study. Remember, taking part in any study is entirely voluntary, and you have the right to withdraw at any time without affecting your future medical care.

Locations (96)

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

Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
Verified postcode
Marietta, United States
Illinois Cancer Care
Verified postcode
Peoria, United States
New England Cancer Specialists
Verified postcode
Scarborough, United States
Dana Farber Cancer Institute
Verified postcode
Boston, United States
Cancer & Hematology Centers of Western Michigan
Verified postcode
Grand Rapids, United States
Mercy Research - St. Louis
Verified postcode
St Louis, United States
Clinical Research Alliance
Verified postcode
Westbury, United States
The Mark H. Zangmeister Ctr
Verified postcode
Columbus, United States
Fox Chase Cancer Center
Verified postcode
Philadelphia, United States
Rhode Island Hospital
Verified postcode
Providence, United States
Hollings Cancer Center
Verified postcode
Charleston, United States
Greco-Hainesworth Centers for Research
Verified postcode
Chattanooga, United States

Common questions

What is 'extensive-stage small-cell lung cancer'?

This is a type of lung cancer that has already spread beyond the lung where it started to other parts of the body.

What are atezolizumab and lurbinectedin?

Atezolizumab is an immunotherapy that helps your own immune system fight cancer. Lurbinectedin is another type of anti-cancer drug.

What does 'randomized' mean?

It means you'll be assigned to one of the treatment groups by chance, like flipping a coin. Neither you nor your doctor chooses which group you are in.

Will I know which treatment I am getting?

Yes, this is an 'open-label' study, which means both you and your medical team will know which treatment you are receiving.

What happens after the initial treatment phase?

If your cancer is stable or has improved after the initial treatment, you may be invited to continue into the second phase, receiving either one study drug or a combination.