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)
NCT ID: NCT06731907
Last Updated: 2026-02-18
Study Results
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Basic Information
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RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2025-03-30
2032-03-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Pembrolizumab and Chemotherapy
Pembrolizumab will be administered as a 200mg IV infusion on Day 1 of every three weeks (Q3W) for up to 35 cycles (\~ 2 years). The doublet platinum-based chemotherapy treatments used in this substudy are standard-of care regimens for squamous (paclitaxel/Nab-paclitaxel and carboplatin) and nonsquamous (pemetrexed and carboplatin) NSCLC. Pemetrexed is administered as a 500mg/m\^2 IV infusion Q3W until discontinuation criterion is met. Nab-paclitaxel will be administered as a 100mg/m\^2 IV infusion on Days 1, 8, and 15 Q3W for up to 4 cycles. Paclitaxel will be administered as a 200 mg/m\^2 IV infusion on Day 1 Q3W for up to 4 cycles. Carboplatin will be administered as an IV infusion area under the time x concentration curve (AUC) for 4 cycles as per local practice and labels. The dose will be AUC5 or 6 mg/mL•min Q3W and will not exceed 900mg.
Pembrolizumab
Pembrolizumab 200mg IV Infusion.
Carboplatin
Carboplatin IV infusion AUC5 or 6 mg/mL•min and not exceeding 900mg.
Paclitaxel
Paclitaxel 200 mg/m\^2 IV infusion.
Nab-paclitaxel
Nab-paclitaxel 100mg/m\^2 IV infusion.
Pemetrexed
Pemetrexed 500mg/m\^2 IV infusion.
Pembrolizumab and HER3-DXd
Pembrolizumab will be administered as a 200mg IV infusion on Day 1 Q3W for up to 35 cycles (\~ 2 years). HER3-Dxd will be administered as 5.6mg/kg IV infusion on Day 1 Q3W until discontinuation criteria is met.
Pembrolizumab
Pembrolizumab 200mg IV Infusion.
HER3-DXd
HER3-Dxd 5.6mg/kg IV infusion.
Interventions
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Pembrolizumab
Pembrolizumab 200mg IV Infusion.
Carboplatin
Carboplatin IV infusion AUC5 or 6 mg/mL•min and not exceeding 900mg.
Paclitaxel
Paclitaxel 200 mg/m\^2 IV infusion.
Nab-paclitaxel
Nab-paclitaxel 100mg/m\^2 IV infusion.
Pemetrexed
Pemetrexed 500mg/m\^2 IV infusion.
HER3-DXd
HER3-Dxd 5.6mg/kg IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 7 days before randomization.
* Has archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided.
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on ART.
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to treatment randomization.
Exclusion Criteria
* Participants with squamous histology are excluded if there is a known tumor-activating epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) or c ros oncogene 1 (ROS1) gene rearrangement.
* Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement.
* Has evidence of any leptomeningeal disease.
* Has known history of, or active, neurologic paraneoplastic syndrome.
* Has clinically significant corneal disease.
* Has myocardial infarction within 6 months.
* Has New York Heart Association (NYHA) Classes 3 or 4 congestive heart failure.
* Has uncontrolled angina pectoris within 6 months.
* Has cardiac arrhythmia requiring ongoing antiarrhythmic treatment.
* Has history of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes.
* Has bradycardia of less than 50 beats per minute (bpm) unless the participant has a pacemaker.
* Has history of second- or third-degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers and have no history of fainting or clinically relevant arrhythmia with pacemakers.
* Has coronary/peripheral artery bypass graft within 6 months.
* Has complete left bundle branch block.
* Has inadequate washout period from prior concomitant therapy as specified in protocol before randomization.
* Has received prior treatment with a topoisomerase I inhibitor or an anti-HER3 antibody and/or ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor.
* Has received prior systemic anticancer therapy for their metastatic NSCLC.
* Has received prior therapy with an anti- programmed cell death 1 protein (anti-PD-1), anti- programmed cell death ligand 1 protein (anti-PD-L1), or anti- programmed cell death ligand 2 protein (anti-PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
* Has received prior radiotherapy within 2 weeks of randomization, has radiation related toxicity requiring corticosteroids, or has had radiation pneumonitis.
* Has received radiation therapy to the lung that is \>30 gray within 6 months of start of study intervention.
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
* Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
* Has known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Has severe hypersensitivity to any of the study interventions and/or any of their excipients.
* Has active autoimmune disease that has required systemic treatment in the past 2 years.
* Has active infection requiring systemic therapy.
* Has concurrent active Hepatitis B and Hepatitis C virus infection.
* Have not adequately recovered from major surgery or have ongoing surgical complications.
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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 District, , 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
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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2024-515772-12-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1309-7532
Identifier Type: REGISTRY
Identifier Source: secondary_id
KEYMAKER U01
Identifier Type: OTHER
Identifier Source: secondary_id
MK-3475-01G
Identifier Type: OTHER
Identifier Source: secondary_id
3475-01G
Identifier Type: -
Identifier Source: org_study_id
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