Study of raludotatug deruxtecan, ifinatamab deruxtecan and docetaxel in patients with previously treated stage IV squamous non-small cell lung cancer

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What is this study about?

This clinical trial focuses on treating patients with Stage IV Squamous Non-Small Cell Lung Cancer who have previously received other treatments. The study will test three different medications: Raludotatug Deruxtecan (also known as MK-5909), Ifinatamab Deruxtecan (also known as MK-2400), and Docetaxel. These medications are given through intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The main purpose of this study is to determine how well these treatments work in fighting lung cancer and to evaluate their safety when used individually. The medications will be administered over a period of up to 24 months, with different dosing schedules for each drug. Raludotatug Deruxtecan will be given at doses up to 5.6 mg per kilogram of body weight, Ifinatamab Deruxtecan at doses up to 12 mg per kilogram, and Docetaxel at doses up to 75 mg per square meter of body surface area.

During the study, doctors will monitor how the cancer responds to treatment and track any side effects that may occur. The study will measure how many patients’ tumors shrink or disappear, how long the treatment effects last, how long patients live without their cancer getting worse, and overall survival time. This research is part of a larger study called KEYMAKER-U01, which is investigating various treatment options for lung cancer.

1 Initial screening and eligibility confirmation

Medical evaluation to confirm stage IV squamous non-small cell lung cancer diagnosis

Verification of previous treatments including anti-PD-(L)1 treatment and platinum-based chemotherapy

Assessment of disease progression using medical imaging

2 Treatment assignment

Random assignment to one of three treatment groups:

Group 1: Raludotatug Deruxtecan given through intravenous infusion

Group 2: Ifinatamab Deruxtecan given through intravenous infusion

Group 3: Docetaxel given through intravenous infusion

3 Treatment period

Regular visits to receive assigned medication through intravenous infusion

Monitoring of treatment response through medical imaging

Regular health assessments to check for side effects

Documentation of any adverse reactions to the treatment

4 Response evaluation

Regular assessment of tumor response using medical imaging

Evaluation of how long the treatment remains effective

Monitoring of cancer progression

Assessment of overall health status

5 Long-term follow-up

Continued monitoring of health status

Regular check-ups to assess long-term treatment effects

Documentation of survival outcomes

Study participation continues until March 2032

Who Can Join the Study?

  • Must have confirmed Stage IV squamous non-small cell lung cancer through tissue or cell examination
  • Must show disease progression after receiving two types of previous treatments:
    – Treatment targeting PD-L1 (a protein that helps control immune system responses)
    Platinum-based chemotherapy (a standard type of cancer treatment)
  • Must be an adult (18 years or older)
  • Both men and women can participate
  • If living with HIV, must have the condition well controlled with antiviral medications
  • If positive for Hepatitis B, must have:
    – Been on antiviral treatment for at least 4 weeks
    – No detectable virus in blood tests
  • If having a history of Hepatitis C, must have no detectable virus in blood tests

Who Cannot Join the Study?

  • Patients with a history of small cell lung cancer (a different type of lung cancer)
  • Patients who have received any prior systemic cancer therapy for stage IV disease
  • Patients with active or untreated brain metastases (cancer that has spread to the brain)
  • Patients with known autoimmune diseases (conditions where the immune system attacks healthy cells)
  • Patients who have received live vaccines within 30 days before starting the study treatment
  • Patients with active infections requiring systemic treatment
  • Patients with uncontrolled cardiovascular disease (serious heart conditions)
  • Pregnant or breastfeeding women
  • Patients participating in other clinical trials within 30 days before this study
  • Patients with known hypersensitivity to the study medications
  • Patients unable to swallow oral medications
  • Patients with severe liver or kidney dysfunction
  • Patients with uncontrolled diabetes or other serious medical conditions

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet Szolnok Hungary
Evangelismos S.A. Athens Greece
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow Poznan Poland
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Iofcfizu Cmhhco Dztobejbjqhxrphls L'hospitalet De Llobregat Spain
Gmytbfeqgmgkvpxuk Vlchgbmii Pdjw Anflxs Epazibjp Onmobw Kotykv Gyor Hungary
Abijmc Mdxdzcn Cxzinp Slse Thessaloniki Greece
Ufkfvmncycpszc Crtolpp Kljgfyzls Gdansk Poland
Boqrtbvqoqo Vbjyetdkm Oywjvfgxghsl Kecskemet Hungary
Lqhns Gdwafqc Hqcmxyos Og Antzts Athens Greece
Nyxjvmih Ibqellgq Owjkjztwg Itp Mffde Skyxwxvhnxqrxwibudpefzdfzsbd Ifbizpgw Bopevurg Cracow Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
30.06.2025
Greece Greece
Recruiting
30.06.2025
Hungary Hungary
Recruiting
30.06.2025
Italy Italy
Recruiting
30.06.2025
Poland Poland
Recruiting
30.06.2025
Spain Spain
Recruiting
30.06.2025

Trial locations

Based on the provided data, I cannot extract specific medications or therapies, as the trial data does not contain information about the products or treatments used. The trial appears to be an umbrella study for investigating treatments in patients with squamous non-small cell lung cancer (NSCLC), but the specific medications or investigational agents are not listed in the provided data. To properly list and describe the medications, I would need information about the actual treatments being studied in this trial.

Stage IV Squamous Non-Small Cell Lung Cancer – A form of lung cancer that begins in the flat cells (squamous cells) lining the larger airways of the lungs and has spread extensively throughout the body. This type of cancer develops from the epithelial cells of the lung tissue and is characterized by the distinctive appearance of squamous cells under microscopic examination. The disease progresses through the lungs and can form secondary tumors in other parts of the body. At stage IV, the cancer has spread beyond the lungs to other organs or areas of the body. This condition affects the normal functioning of the lungs and can impact other organs where the cancer has spread.

Trial ID:
2024-518839-11-00
Protocol code:
MK-3475-01I
Trial Phase:
Therapeutic exploratory (Phase II)

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