RecruitingPhase II🇵🇱 PolandEN originalLung cancerMetastatic / advanced

A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

Researchers are looking for new ways to treat metastatic nonsquamous non-small cell lung cancer (NSCLC) that has been treated before. Metastatic means the cancer has spread to other parts of the body. Nonsquamous means the cancer did not start in squamous cells, which are flat cells that line the inside of the lungs. Standard treatment (usual treatment) for NSCLC is surgery, then immunotherapy with or without chemotherapy after surgery. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is a medicine that works to destroy cancer cells or stop them from growing. However, standard treatment may not work or may stop working for some people. Researchers want to know if 2 antibody drug conjugates (ADCs) can help treat metastatic nonsquamous NSCLC that did not respond (get smaller or go away) to treatment. An ADC attaches to specific targets on cancers cells and delivers treatment to destroy those cells. Researchers will compare 2 different ADCs (the study treatments) to chemotherapy in this study. The goals of this study are to learn: * About the safety of the study treatments and if people tolerate them * How many people have the cancer respond to the study treatments

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Zdiagnozowany rak płuca (nie z płaskich komórek) w IV stadium, który rozprzestrzenił się po organizmie.
  • Rak nie zareagował na wcześniejsze leczenie (immunoterapię i chemioterapię).
  • Nie ma potrzeby stosowania innych ukierunkowanych terapii (np. EGFR-, ALK-, ROS1-).
  • Rak daje się zmierzyć na badaniach obrazowych.
  • Przewidywana długość życia pacjenta to co najmniej 3 miesiące.
  • Ogólny stan zdrowia pacjenta pozwala na udział w badaniu (nie jest zbyt słaby).
  • Pacjent ma co najmniej 18 lat.
  • Uczestnicy muszą mieć odpowiednio działające narządy.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 6, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (34)

University of Kentucky Chandler Medical Center ( Site 0019)

Lexington, United States

MedStar Franklin Square Medical Center ( Site 0033)

Baltimore, United States

AHN Cancer Institute - Allegheny General ( Site 9501)

Pittsburgh, United States

Centro de Estudios Clínicos SAGA ( Site 0161)

Santiago, Chile

FALP ( Site 0160)

Santiago, Chile

Bradfordhill ( Site 0162)

Santiago, Chile

Universitaetsklinik Tuebingen ( Site 0192)

Tübingen, Germany

Charite-Universitaetsmedizin Berlin ( Site 0191)

Berlin, Germany

THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 0204)

Athens, Greece

European Interbalkan Medical Center ( Site 0205)

Thessaloniki, Greece

Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 0063)

Kecskemét, Hungary

Petz Aladar Egyetemi Oktato Korhaz ( Site 0062)

Győr, Hungary

Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet ( Site 0061)

Szolnok, Hungary

Rambam Health Care Campus ( Site 0076)

Haifa, Israel

Shaare Zedek Medical Center ( Site 0075)

Jerusalem, Israel

Meir Medical Center ( Site 0071)

Kfar Saba, Israel

Rabin Medical Center ( Site 0074)

Petah Tikva, Israel

Sheba Medical Center ( Site 0070)

Ramat Gan, Israel

Sourasky Medical Center ( Site 0077)

Tel Aviv, Israel

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)

Milan, Italy

Azienda Ospedaliera Universitaria Careggi ( Site 0173)

Florence, Italy

Ospedale San Raffaele. ( Site 0171)

Milan, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174)

Roma, Italy

Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0153)

Poznan, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0151)

Warsaw, Poland

Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)

Gdansk, Poland

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 0152)

Koszalin, Poland

Institut Català d'Oncologia - L'Hospitalet ( Site 0090)

L'Hospitalet de Llobregat, Spain

Hospital Universitario Quiron Madrid ( Site 0091)

Madrid, Spain

Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0141)

Adana, Turkey (Türkiye)

Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0140)

Ankara, Turkey (Türkiye)

Ankara Bilkent Şehir Hastanesi. ( Site 0142)

Ankara, Turkey (Türkiye)

I. U. Cerrahpasa Tip Fakultesi ( Site 0144)

Istanbul, Turkey (Türkiye)

Ege Universitesi Hastanesi ( Site 0143)

Izmir, Turkey (Türkiye)

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/7/2026.

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