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

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What is this study about?

This study focuses on patients with Stage IV Non-small Cell Lung Cancer (NSCLC) who have already received previous treatments. The study evaluates three different medications: Ifinatamab Deruxtecan (also known as MK-2400), Raludotatug Deruxtecan (also known as MK-5909), and Docetaxel. These medications are given through intravenous infusion, which means they are administered directly into a vein.

The purpose of this research is to evaluate how well these treatments work in treating advanced non-squamous non-small cell lung cancer and to assess their safety. The study specifically includes patients whose cancer has progressed after receiving both platinum-based chemotherapy and immunotherapy treatments. The treatment period may last up to 24 months, during which patients will receive regular doses of one of the study medications.

Throughout the study, participants will undergo regular medical evaluations to monitor their response to treatment and any side effects. The research team will track various aspects of the participants’ health, including how the tumor responds to treatment, how long the response lasts, and how long patients survive without their disease getting worse. The study will use specialized imaging to measure changes in tumor size and assess the effectiveness of the treatment.

1 Initial assessment

Your eligibility for the study will be confirmed through medical tests and examinations

A tumor tissue sample will be collected through a new biopsy

Your organ function and overall health status will be evaluated

A pregnancy test will be performed if applicable

2 Treatment assignment

You will be randomly assigned to receive one of the following medications through intravenous infusion:

– Ifinatamab deruxtecan

– Docetaxel

– Raludotatug deruxtecan

3 Treatment period

You will receive the assigned medication through intravenous infusion

Your response to treatment will be monitored using imaging scans

Regular assessments will track your health status and any side effects

Your tumor response will be evaluated using RECIST criteria (standardized measurement of tumor changes)

4 Ongoing monitoring

Regular medical examinations will be performed to assess your health status

Imaging scans will be conducted to monitor your disease progression

Side effects will be tracked and documented throughout the study

Treatment will continue as long as you are benefiting from it and no serious side effects occur

5 Study completion

The study will continue until 2032

Your participation may end earlier if your disease progresses or you experience unacceptable side effects

A final assessment will be performed when your participation ends

Who Can Join the Study?

  • Must be at least 18 years old and able to provide informed consent
  • Must have confirmed advanced non-squamous non-small cell lung cancer (Stage IV)
  • Must have measurable disease that can be evaluated using specific imaging criteria
  • Must have previously received two types of treatment: platinum-based chemotherapy and immunotherapy (anti-PD-(L)1 therapy), with disease progression after these treatments
  • Must have confirmation that targeted therapies for specific genetic mutations (EGFR, ALK, ROS1) are not needed
  • Must have a good level of physical function (ECOG score 0-1, meaning able to perform daily activities)
  • Must have adequate organ function
  • Must have a life expectancy of at least 3 months
  • Must provide a tissue sample from a tumor that has not been previously treated with radiation
  • Must provide a new tumor tissue sample from a fresh biopsy
  • If able to become pregnant, must not be pregnant or breastfeeding and must use effective contraception
  • If able to produce sperm, must use appropriate contraception and avoid sperm donation
  • If HIV-positive, must have well-controlled disease on anti-HIV medication
  • If hepatitis B positive, must have been on antiviral treatment for at least 4 weeks with undetectable virus levels
  • If history of hepatitis C, must have undetectable virus levels during screening

Who Cannot Join the Study?

  • Prior treatment with any anti-cancer therapy (chemotherapy, targeted therapy, or immunotherapy) within 14 days before starting the study
  • History of severe allergic reactions to medications or biological products
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Active autoimmune disease (condition where the immune system attacks healthy cells) requiring systemic treatment
  • Uncontrolled heart conditions including:
    • High blood pressure
    • Irregular heartbeat
    • Heart failure
  • Active infections requiring treatment, including hepatitis B, hepatitis C, or HIV
  • Other active cancers requiring treatment (except for adequately treated non-melanoma skin cancer or cervical cancer)
  • Pregnant or breastfeeding women
  • Significant liver or kidney problems
  • Any condition that, in the opinion of the study doctor, would make participation unsafe

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
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Ospedale San Raffaele S.r.l. Milan Italy
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
Iiivasyy Crjshw Dwmvhstlhxydvdxhi L'hospitalet De Llobregat Spain
Bknwskhlkpr Vsmfwdxoq Ozbvrqsfvpao Kecskemet Hungary
Ldeiv Gtgwtha Hdjddxww Or Agughb Athens Greece
Ggvueugakkglhfrej Vbcetajfh Pcqu Ayndfy Eozrlmiq Oyxfvm Kqgqag Gyor Hungary
Ayromg Mefqcbj Cbadhw Sfnw Thessaloniki Greece
Noqumvmn Ihrgqltt Oruckdrzv Ibh Minui Sjghiunnjbivvzbkrleywyqiutaa Ixprgemd Bqwsboaa Cracow Poland
Ulugkxglkdctnn Chufeyv Kyqvyifuo Gdansk 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

I apologize, but I don’t see any specific medications or therapies listed in the provided trial data. The data only shows that this is a Phase 2 umbrella study for treating Stage IV nonsquamous non-small cell lung cancer (NSCLC), but the actual investigational agents are not specified in the source data. Without information about the specific medications or therapies being studied, I cannot provide descriptions of them.

If you would like me to describe medications for this trial, please provide additional data that includes the specific investigational agents or therapies being studied.

Non-small Cell Lung Cancer – A type of lung cancer that begins in the large cells of the lungs, including squamous cells and adenocarcinomas. It develops when cells in the lungs grow uncontrollably, forming tumors that can spread to nearby tissues. The disease typically starts in the cells lining the bronchi and parts of the lung such as the bronchioles or alveoli. Initially, it may not cause noticeable symptoms, but as it progresses, it can lead to persistent coughing, chest pain, and breathing difficulties. This cancer grows and spreads more slowly than small cell lung cancer.

Trial ID:
2024-518761-10-00
Protocol code:
MK-3475-01H
Trial Phase:
Therapeutic exploratory (Phase II)

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