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RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002)

This research study is about finding better ways to treat a type of lung cancer called extensive-stage small cell lung cancer (SCLC) when it has returned or isn't getting better with current treatments. The study is looking at two new medications: Gocatamig, which helps your body's immune system fight cancer, and Ifinatamab Deruxtecan (I-DXd), which targets and kills cancer cells directly. Another existing immune-boosting drug, Durvalumab, is also being tested. The main goals are to find out if these drugs are safe, if they cause side effects, and if they can make the cancer shrink or go away. This is important for people whose cancer hasn't responded to previous treatments.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
262
Start
27 Feb 2025
Estimated completion
17 Jan 2030

What is this study about?

This study is for people with a type of lung cancer called extensive-stage small cell lung cancer (SCLC). Extensive-stage means the cancer has spread. Sometimes, after initial treatments, this type of cancer can come back or stop responding to the medicines. When this happens, doctors are always looking for new and better ways to help patients.

That's where this study comes in. Researchers are testing two new drugs, Gocatamig and Ifinatamab Deruxtecan (often called I-DXd). Gocatamig is like a boost for your body's own defence system, called the immune system. It helps your immune system recognise and attack cancer cells. I-DXd is a clever medicine that finds cancer cells and delivers treatment directly to them, aiming to destroy them. The study also looks at using Gocatamig with another immune-boosting drug called Durvalumab, which is already used to fight some cancers.

The main reasons for doing this study are to see if these new treatments are safe for patients and to find out if they can help shrink or get rid of the cancer. By testing these drugs, alone and in combinations, doctors hope to find more effective options for people with this challenging form of lung cancer. The study will happen in different parts, allowing researchers to carefully check the safety and how well the treatments work. They also want to understand if different doses might be better.

Key takeaways

  • This study is for advanced small cell lung cancer that has returned or isn't responding to previous treatment.
  • It tests new drugs, Gocatamig (an immunotherapy) and Ifinatamab Deruxtecan (a targeted drug), alone or in combination with Durvalumab.
  • The main goals are to check the safety of these treatments and if they can shrink the cancer.
  • You need to have specific cancer history and meet certain health criteria to join.
  • Regular hospital visits, tests, and scans will be part of the study.
  • You can stop participating in the study at any time.

Who may be eligible?

To be considered for this study, you must be at least 18 years old and have extensive-stage small cell lung cancer that has been confirmed by a doctor. This means your cancer has spread, and it must have either come back or not responded to at least one previous treatment that included a type of chemotherapy called platinum-based chemotherapy. You will also need to provide a sample of your tumour tissue, either an existing one or a new biopsy. If you have HIV, you can still participate as long as your HIV is well-controlled with medication.

There are several reasons why you might not be able to join this study. For example, if you have fluid build-up around your lungs, heart, or in your belly that needs frequent draining. You also can't join if you have certain lung conditions, like a history of serious lung inflammation, or severe breathing difficulties from other illnesses. Recent heart problems, such as a heart attack, serious heart failure, or uncontrolled irregular heartbeats within the last six months, would also prevent you from taking part.

Other reasons you might not be eligible include a recent blood clot in your brain (stroke or mini-stroke), active infections that need strong medication, a history of an organ transplant, or cancer that has spread to the lining of your brain and spinal cord. If you've had recent radiation therapy or are taking high doses of steroid medication or other medicines that suppress your immune system, you also wouldn't be able to join 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. I am 18 years old or older.
  2. I have extensive-stage small cell lung cancer that has come back or didn't respond to past treatment.
  3. My previous treatment included a type of chemotherapy called platinum-based chemotherapy.
  4. I can provide a sample of my tumour tissue.
  5. I do not have recent serious heart problems or active serious infections.
  6. I am not taking high doses of steroids or strong immune-suppressing medicines.
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either Gocatamig, Ifinatamab Deruxtecan, or a combination of Gocatamig and Durvalumab. The specific treatment you receive will be decided by the study doctors. You will have regular visits to the hospital or clinic, which will include physical examinations, blood tests, and scans (like CT scans) to see how the treatment is working and check for any side effects. You'll also be asked about your general health and any symptoms you might be experiencing. These visits will help the research team carefully monitor your health and the progress of your cancer. The total length of your participation will depend on how you respond to the treatment and the study plan, but there will also be follow-up appointments after you finish your treatment.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to new treatments (Gocatamig or Ifinatamab Deruxtecan) that are not yet widely available. These treatments could potentially shrink your cancer or slow its growth, especially if standard treatments haven't worked for you. However, there are also potential risks involved. All medications can cause side effects, and some of the treatments in this study are new, so not all side effects are fully known. You might experience side effects like fatigue, nausea, or more serious reactions affecting your immune system or other organs. You will be closely monitored for these. It's important to remember that you can decide to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (48)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Colorado Anschutz Medical Campus ( Site 1110)
    Verified postcode
    Aurora, United States· Recruiting
  • University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111)
    Verified postcode
    Miami, United States· Recruiting
  • University of Chicago ( Site 1108)
    Verified postcode
    Chicago, United States· Recruiting
  • Dana Farber Cancer Institute ( Site 1105)
    Verified postcode
    Boston, United States· Recruiting
  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103)
    Verified postcode
    Hackensack, United States· Recruiting
  • Roswell Park Cancer Institute ( Site 1107)
    Verified postcode
    Buffalo, United States· Recruiting
  • Providence Portland Medical Center ( Site 1101)
    Verified postcode
    Portland, United States· Recruiting
  • Sarah Cannon Research Institute ( Site 7001)
    Verified postcode
    Nashville, United States· Recruiting
  • Medical College of Wisconsin ( Site 1112)
    Verified postcode
    Milwaukee, United States· Recruiting
  • Hospital Universitario Austral ( Site 2204)
    Verified postcode
    Pilar, Argentina· Recruiting
  • Sanatorio Parque ( Site 2203)
    Verified postcode
    Rosario, Argentina· Recruiting
  • Princess Alexandra Hospital ( Site 5300)
    Verified postcode
    Woolloongabba, Australia· Recruiting

Common questions

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

This means your small cell lung cancer has spread beyond its original location in the lung to other parts of your body.

What does 'relapsed/refractory' mean for my cancer?

'Relapsed' means your cancer has come back after treatment. 'Refractory' means your cancer didn't respond to previous treatments or has stopped responding.

Are the study drugs chemotherapy?

No, Gocatamig and Durvalumab are types of immunotherapy, which use your body's immune system to fight cancer. Ifinatamab Deruxtecan is a targeted drug that finds and destroys cancer cells directly.

Will I know which treatment I am getting?

The study design will determine whether you know which specific drug or combination you are receiving. The research team will explain this to you clearly.

How long will I be in the study?

The length of your participation will depend on how your body responds to the treatment and the study plan. The study team will discuss the expected duration with you.

How to find out more

Toll Free Number

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Evaluate the Safety and Efficacy of Gocatamig (MK…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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