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RecruitingPHASE2INTERVENTIONAL

Substudy 01I: A Study of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01I/KEYMAKER-U01I)

This study is investigating new ways to treat a type of advanced lung cancer called squamous non-small cell lung cancer (NSCLC). This is a cancer that started in the lining of the lungs and has spread to other parts of the body. Standard treatments, like immunotherapy or chemotherapy, haven't worked for the participants in this study. Researchers are testing new drugs called antibody drug conjugates (ADCs). These ADCs are designed to attach to cancer cells and deliver medicine directly to them, hopefully destroying them. The main goals are to see how well these new treatments shrink the cancer compared to chemotherapy, and to understand if they are safe and well-tolerated by patients.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
144
Start
28 May 2025
Estimated completion
02 Mar 2032

What is this study about?

This study is exploring new treatments for a specific type of lung cancer called squamous non-small cell lung cancer (NSCLC) which has spread to other parts of the body. This means the cancer is advanced, or "Stage IV." In this type of cancer, the cells that line the airways of the lungs become cancerous. For patients whose cancer hasn't responded well to standard treatments like immunotherapy or chemotherapy, finding new options is really important.

The researchers want to see if a new type of medicine, called an 'antibody drug conjugate' (ADC), can help. You can think of an ADC like a smart bomb: it has a special part that finds and attaches only to cancer cells, and then it delivers a powerful anti-cancer drug directly to those cells, hopefully sparing healthy ones. This study aims to find out if these new ADC treatments are better at shrinking the cancer than standard chemotherapy, and whether they are safe for people to use.

Ultimately, the goal is to find effective new ways to treat advanced squamous non-small cell lung cancer, especially for those who have limited options left. By comparing the new ADCs to existing chemotherapy, the researchers hope to gather vital information that could lead to new approved treatments for this challenging disease.

Key takeaways

  • New treatments for advanced squamous lung cancer are being tested.
  • The study focuses on 'antibody drug conjugates' (ADCs) as potential new therapies.
  • It's for people whose cancer hasn't responded to usual immunotherapy and chemotherapy.
  • The main goals are to check if the new treatments shrink cancer and if they are safe.
  • Participation involves regular hospital visits for treatments, tests, and monitoring.

Who may be eligible?

To join this study, you must be an adult aged 18 or over and have a confirmed diagnosis of advanced squamous non-small cell lung cancer that has spread. Importantly, your cancer must have continued to grow despite having received prior treatment with both a type of immunotherapy (anti-PD-1/PD-L1) and chemotherapy that contained platinum for your advanced cancer.

There are also some medical conditions that would prevent you from taking part, such as active and uncontrolled heart problems, severe lung conditions, or if you've already received a specific chemotherapy drug called docetaxel on its own or with other treatments. If you have HIV or Hepatitis B or C, you might still be able to join if your condition is well-managed with treatment and your viral levels are undetectable.

Minor side effects from previous cancer treatments must have mostly cleared up. The study team will review all your medical information to make sure it's safe and appropriate for you to participate.

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. Do you have a diagnosis of advanced (Stage IV) squamous non-small cell lung cancer?
  3. Has your cancer grown after receiving both immunotherapy and platinum-based chemotherapy?
  4. Do you have any serious, uncontrolled heart or lung conditions?
  5. Have you previously been treated with the chemotherapy drug Docetaxel by itself or with other medicines?
  6. Are any side effects from your previous cancer treatments mostly gone or very mild?
Answer every question to see your result.

What does participation involve?

If you join this study, you would receive one of the investigational (study) medicines or standard chemotherapy, as decided by the study team. You would receive these treatments at regular intervals, likely through an infusion (drip) in a hospital or clinic setting. There would be regular hospital visits for blood tests, physical examinations, and scans (like CT scans) to monitor your health and how the treatment is affecting the cancer.

While the exact schedule isn't detailed, clinical trials typically involve frequent visits at the beginning, becoming less frequent over time. You would also be asked about any side effects you experience. If your cancer gets worse, you might be offered 'rescue medications' to help. The total duration of your participation would depend on how your cancer responds and how you tolerate the treatment, but it could last for many months.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to new treatments before they are widely available, and close monitoring of your health by medical experts. However, there are also potential risks; the new treatments might cause side effects, some of which could be serious or unexpected, and they might not work for everyone. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (40)

  • University of Kentucky Chandler Medical Center ( Site 0019)
    Verified postcode
    Lexington, United States· Recruiting
  • MedStar Franklin Square Medical Center ( Site 0033)
    Verified postcode
    Baltimore, United States· Recruiting
  • Centro de Estudios Clínicos SAGA ( Site 0161)
    Verified postcode
    Santiago, Chile· Recruiting
  • FALP ( Site 0160)
    Verified postcode
    Santiago, Chile· Recruiting
  • Bradfordhill ( Site 0162)
    Verified postcode
    Santiago, Chile· Recruiting
  • Chongqing University Cancer Hospital ( Site 0304)
    Verified postcode
    Chongqing, China· Recruiting
  • Fujian Provincial Cancer Hospital ( Site 0310)
    Verified postcode
    Fuzhou, China· Recruiting
  • Guangxi Medical University Cancer Hospital ( Site 0303)
    Verified postcode
    Nanning, China· Recruiting
  • Henan Cancer Hospital ( Site 0311)
    Verified postcode
    Zhengzhou, China· Recruiting
  • Nanjing Drum Tower Hospital JiangBei International Branch Hospital ( Site 0309)
    Verified postcode
    Nanjing, China· Recruiting
  • Shanghai Chest Hospital ( Site 0308)
    Verified postcode
    Shanghai, China· Recruiting
  • Shanghai Pulmonary Hospital ( Site 0300)
    Verified postcode
    Shanghai, China· Recruiting

Common questions

What is an antibody drug conjugate (ADC)?

An ADC is a new type of medicine that targets cancer cells specifically. It's like a guided missile that attaches to a protein on the cancer cell and delivers powerful medicine directly to it, aiming to destroy the cell while limiting harm to healthy parts of your body.

What kind of lung cancer is this study for?

This study is for people with advanced (Stage IV) squamous non-small cell lung cancer (NSCLC) that has already been treated with immunotherapy and platinum-based chemotherapy, but their cancer has continued to grow.

Will I definitely get the new treatment?

Participants will receive either one of the new investigational treatments (ADCs) or standard chemotherapy. The specific treatment you receive will be decided by the study team as part of the trial design.

What are the main goals of the study?

The study aims to find out how well the new treatments shrink the cancer compared to chemotherapy, and to check how safe they are and if people can tolerate them well.

What if I have other health conditions like HIV or Hepatitis?

If you have HIV or Hepatitis B or C, you might still be eligible if these conditions are well-controlled with medication and your viral levels are undetectable.

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 "Substudy 01I: A Study of Investigational Agents in Participa…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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