Active not recruitingPHASE3INTERVENTIONAL

Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008/KEYVIBE-008)

This clinical trial investigated new treatments for extensive-stage small cell lung cancer (ES-SCLC), which is a common and serious type of lung cancer. Initially, it compared a new combination of medicines (Pembrolizumab/Vibostolimab) with standard chemotherapy against a different combination (Atezolizumab) also with chemotherapy. The main goal was to see which treatment helped patients live longer. However, the first treatment arm (Pembrolizumab/Vibostolimab) was stopped early, and participants were offered to switch to the Atezolizumab treatment. This means the study's focus shifted, and it primarily helps us understand the Atezolizumab approach for people with this condition. It's a Phase 3 trial, meaning it's a large study testing new treatments against current best practices.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

460

Start

24 Mar 2022

Estimated completion

07 Jun 2027

Small Cell Lung Carcinoma

Results

Results from this study

Posted May 2025

Results have been published for this study.

Primary outcome

Overall Survival (OS)

Overall Survival (OS) was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was calculated using the nonparametric Kaplan-Meier method for censored data.

Full results on the registry

What is this study about?

This study, known as KEYVIBE-008, was designed to find better ways to treat a serious form of lung cancer called extensive-stage small cell lung cancer (ES-SCLC). This type of cancer has spread to various parts of the body. Doctors are always looking for more effective treatments than the standard chemotherapy currently used.

Initially, this study aimed to compare two different approaches. One group of patients would receive a new combination of two medicines (Pembrolizumab and Vibostolimab) along with chemotherapy. The other group would receive a different medicine (Atezolizumab) with the same chemotherapy. The main question the researchers wanted to answer was: Does the new combination of medicines help people with this type of lung cancer live longer compared to the Atezolizumab combination?

However, during the course of the study, the first treatment arm involving Pembrolizumab/Vibostolimab was stopped. Participants who were on this treatment were given the option to switch to the Atezolizumab arm if appropriate. This means the study will now mainly provide information about the Atezolizumab treatment. While the full comparison couldn't be completed, the information gathered still contributes to our understanding of how to treat extensive-stage small cell lung cancer.

Key takeaways

The study aimed to improve treatment for extensive-stage small cell lung cancer.
It compared different medicine combinations with chemotherapy.
One experimental treatment arm was stopped during the study.
Information from the Atezolizumab arm still contributes to medical knowledge.
Participation involved regular hospital visits and health monitoring.
You always have the right to leave a study at any time.

Who may be eligible?

To join this study, people needed to have extensive-stage small cell lung cancer (ES-SCLC) that had not yet been treated. This means the cancer had spread quite widely. You also needed to be generally well enough to take part and expected to live for more than three months. Your cancer also needed to be visible and measurable on scans and tests.

There were certain reasons you couldn't join. For example, if you had other serious medical conditions that researchers felt would make the study unsafe, or if you had received any other treatments for your small cell lung cancer already. You also couldn't have other active cancers or certain immune system problems. If you had serious spread of cancer to your brain, that would also typically exclude you.

Women who were pregnant or breastfeeding couldn't take part, and both men and women of childbearing age needed to agree to use effective contraception during the study. It's really important that these studies are as safe as possible for everyone involved.

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 extensive-stage small cell lung cancer (ES-SCLC)?
Have you *not* received any prior treatment for this specific lung cancer?
Are you generally well enough to participate in a study?
Are you aged 18 or older?
Do you understand the need for contraception if applicable?

Answer every question to see your result.

What does participation involve?

If you had joined this study, you would have received treatment that involved regular medication. This included either a combination of medicines with chemotherapy, or just one medicine with chemotherapy, depending on which group you were in and given the changes to the study. These treatments are given through a drip (intravenously).

Participation also meant regular visits to the hospital or clinic for blood tests, scans, and doctor check-ups to monitor your health and how the treatment was working. You would have been asked to answer questionnaires about your quality of life, although these were later stopped. If you were benefiting from the Atezolizumab treatment but couldn't get it outside the study, you might have been able to continue receiving it until it was no longer helpful or other specific reasons meant stopping. The total duration of participation varied for each person, depending on how their treatment progressed.

Potential risks and benefits

Taking part in a clinical trial might offer the potential benefit of accessing new or different treatments that are not yet widely available. These treatments could be more effective than existing options. However, there are also potential risks, as new medications can have side effects that are not fully known or can be more severe than current treatments. You would have been closely monitored for these. It is always important to remember that participation 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 (140)

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

Infirmary Cancer Care ( Site 0022)
Verified postcode
Mobile, United States
Los Angeles Hematology Oncology Medical Group ( Site 0006)
Verified postcode
Los Angeles, United States
VA West Los Angeles Medical Center ( Site 0004)
Verified postcode
Los Angeles, United States
Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014)
Verified postcode
Boca Raton, United States
Fort Wayne Medical Oncology and Hematology ( Site 0013)
Verified postcode
Fort Wayne, United States
Dana-Farber Cancer Institute ( Site 0018)
Verified postcode
Boston, United States
Cancer and Hematology Centers of Western Michigan ( Site 0001)
Verified postcode
Grand Rapids, United States
Hattiesburg Clinic Hematology/Oncology ( Site 0003)
Verified postcode
Hattiesburg, United States
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005)
Verified postcode
Lancaster, United States
Blue Ridge Cancer Care ( Site 0015)
Verified postcode
Blacksburg, United States
University of Virginia Cancer Center ( Site 0019)
Verified postcode
Charlottesville, United States
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203)
Unverified
Ciudad Autonoma de Buenos Aires, Argentina

Common questions

What type of cancer was this study for?

This study focused on extensive-stage small cell lung cancer (ES-SCLC), which is a type of lung cancer that has spread widely in the body.

What was the main goal of this study?

The main goal was to see if new treatment combinations could help people with this type of lung cancer live longer compared to existing treatments.

Were the treatments in this study approved for everyone?

Some of the treatments might be standard, while others were investigational and not yet widely available outside of clinical trials.

Can I still join this study?

No, the study has been significantly changed, and the main drug being investigated was discontinued early. It is no longer recruiting new participants for the original comparison.

What happened to the original treatment being tested?

One of the treatment arms (Pembrolizumab/Vibostolimab) was stopped, and participants were offered the option to switch to the other treatment arm (Atezolizumab).