All studies
Active not recruitingPHASE3INTERVENTIONAL

A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer

This research study is looking into a new medication called SB27 for people with advanced non-small cell lung cancer (NSCLC) that has spread (stage IV). NSCLC is a common type of lung cancer. The study aims to compare SB27 with an already approved medicine, Keytruda, which is also used for this condition. Both SB27 and Keytruda will be given along with standard chemotherapy treatments every three weeks. Researchers want to find out if SB27 is just as effective and safe as Keytruda. This is important because having more treatment options can be very beneficial for patients. The study is designed to make sure SB27 works in a similar way to Keytruda.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Samsung Bioepis Co., Ltd.
Enrolment target
555
Start
12 Mar 2024
Estimated completion
01 Sep 2026

What is this study about?

This study is about creating more options for people living with a type of lung cancer called non-small cell lung cancer (NSCLC), specifically when it's advanced or has spread to other parts of the body (this is called stage IV metastatic NSCLC). There are different ways to treat this condition, and researchers are always looking for new medicines that can help.

In this study, they are focusing on a new medicine called SB27. They want to see how it compares to a treatment that is already commonly used, called Keytruda. Both SB27 and Keytruda are types of modern cancer treatments. Participants in the study will receive either SB27 or Keytruda, along with standard chemotherapy drugs, every three weeks.

The main goal is to find out if SB27 works just as well as Keytruda when it comes to treating this type of lung cancer. "Works just as well" means checking if it helps to control the cancer in a similar way and if it has a similar safety profile. If SB27 proves to be as effective and safe, it could become another valuable treatment choice for patients in the future.

Key takeaways

  • This study compares a new lung cancer drug (SB27) with an existing one (Keytruda).
  • It's for people with advanced non-small cell lung cancer that has spread.
  • Both study drugs will be given along with standard chemotherapy.
  • The main goal is to see if SB27 works as well as Keytruda.
  • Participation involves regular clinic visits for treatment and health checks.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must have been diagnosed with a specific type of lung cancer called non-small cell lung cancer (NSCLC) that has spread to other parts of your body. It's also important that you haven't had any previous drug treatment for this type of advanced lung cancer.

There are also some reasons why you might not be able to join. For example, if you can't or won't take certain vitamins (folic acid and vitamin B12) or if you've had a very severe allergic reaction to similar treatments or any part of the study drugs (SB27, Keytruda, or the chemotherapy).

The research team will carry out several tests to make sure the study is suitable and safe for you. Women who can become pregnant will need to agree to use reliable birth control during the study.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with advanced non-small cell lung cancer (stage IV)?
  3. Have you not had any drug treatment for this advanced lung cancer yet?
  4. Are you able to take folic acid and vitamin B12 supplements?
  5. Have you *not* had a severe allergic reaction to similar cancer drugs or chemotherapy before?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the investigational drug SB27 or the approved drug Keytruda, alongside standard chemotherapy. Both of these treatments would be given to you every three weeks. During your time in the study, you would have regular visits to the clinic for your treatments, as well as to check your health and how you are responding to the medication. This would involve regular physical exams, blood tests, and scans. The exact total duration of your participation would be explained by the study team, but typically, you would continue treatment as long as it benefits you and is safe, followed by a period of follow-up check-ups.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new treatments before they are widely available, and close medical monitoring. However, there are also potential risks, including side effects from the study medicines, which can vary from mild to severe, and the possibility that the treatment might not work for you. You will be fully informed about all known risks and benefits before deciding to participate. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (93)

  • SB Investigative Site
    Verified postcode
    Banja Luka, Bosnia and Herzegovina
  • SB Investigative Site
    Verified postcode
    Mostar, Bosnia and Herzegovina
  • SB Investigative Site
    Verified postcode
    Sarajevo, Bosnia and Herzegovina
  • SB Investigative Site
    Verified postcode
    Curitiba, Brazil
  • SB Investigative Site
    Verified postcode
    Florianópolis, Brazil
  • SB Investigative Site
    Verified postcode
    Ijuí, Brazil
  • SB Investigative Site
    Verified postcode
    Natal, Brazil
  • SB Investigative Site
    Verified postcode
    Pelotas, Brazil
  • SB Investigative Site 1
    Verified postcode
    Porto Alegre, Brazil
  • SB Investigative Site 2
    Verified postcode
    Porto Alegre, Brazil
  • SB Investigative Site
    Verified postcode
    Rio de Janeiro, Brazil
  • SB Investigative Site
    Verified postcode
    Santo André, Brazil

Common questions

What type of cancer is this study for?

This study is for people with advanced non-small cell lung cancer that has spread to other parts of the body.

What are the main drugs being tested?

The main drugs are SB27, which is being studied, and Keytruda, which is an existing treatment. Both will be given with chemotherapy.

Will I know if I'm getting SB27 or Keytruda?

In this type of study, participants are usually randomly assigned to receive one of the treatments. You might not know which one you are getting until the end of the study, but this would be fully explained to you.

How often will I receive treatment?

Treatment would typically be given every three weeks as part of the study.

What is 'metastatic' lung cancer?

Metastatic lung cancer means the cancer has spread from the lungs to other parts of the body.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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