RecruitingPhase 2NCT06731907

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)

KEYMAKER-U01 Substudy 01G: A Phase 2, Umbrella Study With Rolling Arms of Investigational Agents in Combination With Pembrolizumab With or Without Platinum-based Chemotherapy in Treatment-Naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)

Sponsor

Merck Sharp & Dohme LLC

Enrollment

90 participants

Start Date

Mar 30, 2025

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This large study (KEYMAKER U01) is testing different combinations of pembrolizumab (an immunotherapy) with or without chemotherapy, and with additional experimental treatments, for people with Stage IV (metastatic) non-small cell lung cancer (NSCLC) as a first-line treatment. **You may be eligible if...** - You have confirmed Stage IV squamous or non-squamous non-small cell lung cancer - You are in generally good health (able to carry out normal activities with minimal limitation) - You are able to provide a tumor tissue sample - If you have HIV, it must be well controlled on antiretroviral therapy **You may NOT be eligible if...** - You have an actionable mutation (such as EGFR or ALK) with an approved targeted therapy available - You have active, untreated brain metastases - You have active autoimmune disease or are on immunosuppressive medications - You have previously received chemotherapy or immunotherapy for metastatic lung cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALPembrolizumab

Pembrolizumab 200mg IV Infusion.

DRUGCarboplatin

Carboplatin IV infusion AUC5 or 6 mg/mL•min and not exceeding 900mg.

DRUGPaclitaxel

Paclitaxel 200 mg/m\^2 IV infusion.

DRUGNab-paclitaxel

Nab-paclitaxel 100mg/m\^2 IV infusion.

DRUGPemetrexed

Pemetrexed 500mg/m\^2 IV infusion.

BIOLOGICALHER3-DXd

HER3-Dxd 5.6mg/kg IV infusion.

Locations(41)

University of Kentucky ( Site 0019)

Lexington, Kentucky, United States

MedStar Franklin Square Medical Center ( Site 0033)

Baltimore, Maryland, United States

Sanford Fargo Medical Center ( Site 0039)

Fargo, North Dakota, United States

Abramson Cancer Center ( Site 0010)

Philadelphia, Pennsylvania, United States

Sanford Cancer Center ( Site 0038)

Sioux Falls, South Dakota, United States

Centro de Estudios Clínicos SAGA ( Site 0162)

Santiago, Region M. de Santiago, Chile

FALP ( Site 0161)

Santiago, Region M. de Santiago, Chile

Bradfordhill ( Site 0160)

Santiago, Region M. de Santiago, Chile

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

Athens, Attica, Greece

European Interbalkan Medical Center-Oncology Department ( Site 0205)

Thessaloniki, Greece

Petz Aladar Egyetemi Oktato Korhaz ( Site 0062)

Győr, Győr-Moson-Sopron, Hungary

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

Szolnok, Jász-Nagykun-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, Lombardy, 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, Greater Poland Voivodeship, Poland

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

Warsaw, Masovian Voivodeship, Poland

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

Gdansk, Pomeranian Voivodeship, Poland

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152)

Koszalin, West Pomeranian Voivodeship, Poland

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

L'Hospitalet de Llobregat, Barcelona, 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, Cherkasy Oblast, Ukraine

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

Chernivtsi, Chernivetska Oblast, Ukraine

CNCE Precarpathian Clinical Oncologic Center ( Site 0131)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

VISION PARTNER Medical Centre ( Site 0134)

Kyiv, Kyivska Oblast, Ukraine

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

Vinnytsia, Vinnytsia Oblast, Ukraine

Shalimov Institute of Surgery and Transplantation ( Site 0135)

Kyiv, Ukraine

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06731907

Related Trials

Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors

NCT0621891418 locations

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

NCT06692738301 locations

OSIREAL - Osimertinib RWE on EGFRm NSCLC in Spain

NCT0606804925 locations

A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1%

NCT06561386299 locations

Tumor Cell and DNA Detection in the Blood, Urine and Bone Marrow of Patients With Solid Cancers

NCT028388361 location