RecruitingPhase II🇵🇱 PolandEN originalLung cancerMetastatic / advanced

A Study of Pembrolizumab With or Without Chemotherapy in Combination With Additional Treatments for Advanced Non-Small Cell Lung Cancer (NSCLC) (MK-3475-01G/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 investigating new treatments for untreated advanced non-small cell lung cancer (NSCLC), which is the most common form of lung cancer and lung cancer that has spread beyond surgical removal. Standard treatments include immunotherapy, such as pembrolizumab, and chemotherapy. This study aims to determine the effectiveness of adding other treatments, including the human epidermal growth factor receptor 3-directed antibody-drug conjugate (HER3-DXd) patritumab deruxtecan, to pembrolizumab, with or without chemotherapy. The primary goals are to assess safety and efficacy of the treatments.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Potwierdzony nowotok płuca w stadium IV (zaawansowany, rozprzestrzeniony)
  • Ogólny stan zdrowia oceniony na 0 lub 1 (pacjent jest w dobrym stanie do podjęcia leczenia)
  • Dostęp do próbki guza z poprzedniego badania lub świeża biopsja
  • Pacjenci z HIV muszą mieć kontrolowaną chorobę pod leczeniem

✗ Disqualifies

  • Rak płuca drobnokomórkowy lub nowotwór mieszany zawierający komórki drobnokomórkowe
  • Niektóre rzadkie mutacje genetyczne guza (EGFR, ALK, ROS1)
  • Pacjenci z HIV i historią poważnych powikłań (Kaposi, choroba Castelmana)
  • Poważne problemy z płucami lub zapalenia autoimmunologiczne obejmujące płuca
  • Przerzuty do opon mózgowych
  • Udar serca w ciągu ostatnich 6 miesięcy
  • Ciężka niewydolność serca (klasa III-IV)
  • Niekontrolowana choroba naczyniowa serca

Simplified criteria — AI translation

Trial details

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

Therapies / drugs in trial

Locations (41)

University of Kentucky ( Site 0019)

Lexington, United States

MedStar Franklin Square Medical Center ( Site 0033)

Baltimore, United States

Sanford Fargo Medical Center ( Site 0039)

Fargo, United States

Abramson Cancer Center ( Site 0010)

Philadelphia, United States

Sanford Cancer Center ( Site 0038)

Sioux Falls, United States

Centro de Estudios Clínicos SAGA ( Site 0162)

Santiago, Chile

FALP ( Site 0161)

Santiago, Chile

Bradfordhill ( Site 0160)

Santiago, Chile

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

Athens, Greece

European Interbalkan Medical Center-Oncology Department ( Site 0205)

Thessaloniki, Greece

Petz Aladar Egyetemi Oktato Korhaz ( Site 0062)

Győr, Hungary

Jasz-Nagykun-Szolnok Megyei Hetenyi Gyula Korhaz-Rendelointezet ( Site 0061)

Szolnok, Hungary

Országos Korányi Pulmonológiai Intézet ( Site 0060)

Budapest, 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

IRCCS 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-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( 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-Oddzial Dzienny Chemioterapii ( Site 0152)

Koszalin, Poland

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

L'Hospitalet de Llobregat, Spain

HOSPITAL CLÍNIC DE BARCELONA ( Site 0092)

Barcelona, Spain

Hospital Universitario Quiron Madrid ( Site 0091)

Madrid, Spain

Changhua Christian Hospital ( Site 0181)

Changhua, Taiwan

Taipei Medical University Hospital ( Site 0180)

Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch ( Site 0182)

Taoyuan, Taiwan

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

Adana, Turkey (Türkiye)

Hacettepe Universite Hastaneleri ( Site 0140)

Ankara, Turkey (Türkiye)

Ankara Bilkent Şehir Hastanesi ( Site 0142)

Ankara, Turkey (Türkiye)

CNE CC of Oncology Hematol ( Site 0130)

Cherkasy, Ukraine

Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 0136)

Chernivtsi, Ukraine

CNCE Precarpathian Clinical Oncologic Center ( Site 0131)

Ivano-Frankivsk, Ukraine

VISION PARTNER Medical Centre ( Site 0134)

Kyiv, Ukraine

Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 0133)

Vinnytsia, Ukraine

Shalimov Institute of Surgery and Transplantation ( Site 0135)

Kyiv, Ukraine

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/19/2026.

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