Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer
NCT ID: NCT06899126
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
686 participants
INTERVENTIONAL
2025-10-24
2032-07-05
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
NONE
Study Groups
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Arm A: T-DXd
Participants will receive T-DXd plus pembrolizumab
Trastuzumab Deruxtecan
T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)
pembrolizumab
pembrolizumab will be administered at a dose of 200 mg IV Q3W
Arm B: Pemetrexed + Chemotherapy + Pembrolizumab
Participants will receive Pemetrexed plus platinum chemotherapy (cisplatin or carboplatin) plus pembrolizumab
pembrolizumab
pembrolizumab will be administered at a dose of 200 mg IV Q3W
Pemetrexed
Pemetrexed will be administered at a dose of 500 mg/m2 IV Q3W
Chemotherapy
One of the following two will be administered in Arm B:
Cisplatin at a dose of 75 mg/m2 IV or carboplatin AUC at a dose of 5 mg/mL/min IV
Interventions
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Trastuzumab Deruxtecan
T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)
pembrolizumab
pembrolizumab will be administered at a dose of 200 mg IV Q3W
Pemetrexed
Pemetrexed will be administered at a dose of 500 mg/m2 IV Q3W
Chemotherapy
One of the following two will be administered in Arm B:
Cisplatin at a dose of 75 mg/m2 IV or carboplatin AUC at a dose of 5 mg/mL/min IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Sign and date the Optional PGx ICF (included in the Main Screening ICF) prior to any PGx procedure, and the Pregnant Partner ICF, if applicable.
2. Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old.
3. Histologically documented non-squamous locally advanced unresectable or metastatic
NSCLC and meets all of the following criteria:
Has Stage IV NSCLC disease or Stage IIIB or IIIC disease but is not a candidate for surgical resection or definitive chemoradiation at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition). Has no known AGAs (based on existing test result of local test) that have locally available therapies targeting their AGAs in the first-line advanced/metastatic setting. Has no known HER2 mutation based on existing test results (if approved or validated local test is available). Note: Participants with mixed histology are eligible if adenocarcinoma is the predominant histology. Mixed tumors will be classified based on the predominant cell type.
4. Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC. Participants who received adjuvant or neoadjuvant therapy other than those listed below, including ICI (ie, anti-PD-1/PD-L1) or a platinum-based regimen, are eligible if the last dose of adjuvant/neoadjuvant therapy was given at least 6 months before the date of the first trial dose and should not have progressed on or within 6 months of the last dose date of adjuvant/neoadjuvant therapy.
1. Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I.
2. HER2-targeted antibody-based anticancer therapy.
5. Has adequate tumor tissue sample (not previously irradiated) available for assessment of HER2 and PD-L1 expression by central or Sponsor-specified laboratory. A new biopsy is required if the participant's most recent archival tumor tissue sample cannot be supplied.
Details pertaining to tumor tissue submission can be found in the Trial Laboratory Manual.
Exclusion Criteria
2. Has a QTc prolongation to \>480 ms based on the average of the Screening triplicate 12- lead ECG.
3. Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
4. Has lung-specific, intercurrent, clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.).
5. Had a prior complete pneumonectomy.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Daiichi Sankyo
INDUSTRY
Responsible Party
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Locations
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Alaska Oncology & Hematology, LLC
Anchorage, Alaska, United States
Orange Coast Memorial Medical Center Fountain Valley
Fountain Valley, California, United States
California Research Institute
Los Angeles, California, United States
Los Angeles Cancer Network (LACN)
Los Angeles, California, United States
Providence Medical Foundation
Santa Rosa, California, United States
Bay Pines VA Healthcare System
Bay Pines, Florida, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Mid-Florida Hematology & Oncology Centers, P.A.
Orange City, Florida, United States
BRCR Global Plantation
Plantation, Florida, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, United States
Logan Health Research
Kalispell, Montana, United States
Clinical Research Alliance
Westbury, New York, United States
FirstHealth Cancer Center
Pinehurst, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
St. Charles Health System
Bend, Oregon, United States
University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States
Lumi Research
Kingwood, Texas, United States
Summit Cancer Treatment Center
Spokane, Washington, United States
CINME - Centro De Investigaciones Metabolicas
Buenos Aires, , Argentina
Instituto Argentino de Diagnostico y Tratamiento
Buenos Aires, , Argentina
Instituto de Investigaciones Metabolicas (IDIM)
Buenos Aires, , Argentina
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, , Argentina
CHU Helora-Hospital de Mons
Mons, , Belgium
Hospital de Cancer de Barretos - Fundacao Pio XII
Barretos, , Brazil
Centro de Pesquisas Clinica Reichow
Blumenau, , Brazil
CIONC-Centro Integrado de Oncologia de Curitiba
Curitiba, , Brazil
CRIO - Centro Regional Integrado de Oncologia
Fortaleza, , Brazil
Liga Norte-Rio-Grandense Contra o Câncer
Natal, , Brazil
Hospital Ernesto Dornelles
Porto Alegre, , Brazil
Hospital São Lucas da PUCRS
Porto Alegre, , Brazil
Centro de Tratamento Oncologico (CTO)
Ribeirão Preto, , Brazil
Hospital das Clínicas FMRP-USP
Ribeirão Preto, , Brazil
Obras Sociais Irmã Dulce - Hospital Santo Antônio
Salvador, , Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, , Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
Sao Jose Rio Preto, , Brazil
Centro Paulista de Oncologia S A
Vila Olímpia, , Brazil
China-Japan Friendship hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
Sichuan Cancer Hospital
Chengdu, , China
West China Hospital, Sichuan University
Chengdu, , China
Chongqing University Cancer Hospital
Chongqing, , China
Nanfang Hospital of Southern Medical University
Guangzhou, , China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
The Second Hospital of Anhui Medical University
Hefei, , China
Hong Kong Integrated Oncology Centre
Hong Kong, , China
Cancer Hospital of Shandong First Medical University
Jinan, , China
Hong Kong United Oncology Centre
Jordan, , China
Linyi Cancer Hospital
Linyi, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
The Second Affiliated Hospital of Nanchang University
Nanchang, , China
Jiangsu Province Hospital
Nanjing, , China
The Second People's Hospital of Neijiang
Neijiang, , China
Shanghai East Hospital
Shanghai, , China
Liaoning Cancer Hospital & Institute
Shenyang, , China
Shanxi Provincial Cancer Hospital
Taiyuan, , China
Tianjin Medical University General Hospital
Tianjin, , China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, , China
Xiangyang Central Hospital
Xiangyang, , China
Hopital Albert Calmette - CHU Lille
Lille, , France
Saitama Medical University International Medical Center
Hidaka-shi, , Japan
Kansai Medical University Hospital
Hirakata-shi, , Japan
Hirosaki University Hospital
Hirosaki-shi, , Japan
St. Marianna University Hospital
Kawasaki-shi, , Japan
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi, , Japan
Saiseikai Kumamoto Hospital
Kumamoto, , Japan
Kurume University Hospital
Kurume-shi, , Japan
Matsusaka Municipal Hospital
Matsusaka-shi, , Japan
NHO Okayama Medical Center
Okayama, , Japan
Osaka City General Hospital
Osaka, , Japan
Osaka International Cancer Institute
Osaka, , Japan
NHO Kinki-Chuo Chest Medical Center
Sakaishi, , Japan
Keijinkai Teine Keijinkai Hospital
Sapporo, , Japan
Tokyo Medical University Hospital
Shinjuku-ku, , Japan
Shizuoka Cancer Center
Sunto-gun, , Japan
Fujita Health University Hospital
Toyoake-shi, , Japan
Wakayama Medical University Hospital
Wakayama, , Japan
Kanagawa Cancer Center
Yokohama, , Japan
Tottori University Hospital
Yonago-shi, , Japan
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, , Malaysia
Beacon Hospital Sdn Bhd
Petaling Jaya, , Malaysia
Unidade Local de Saude de Santa Maria, E.P.E. - Hospital Pulido Valente
Lisbon, , Portugal
National Cancer Center
Goyang-si, , South Korea
Gyeongsang National University Hospital
Jinju, , South Korea
CHA Bundang Medical Center, CHA University
Seongnam, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, , South Korea
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Chi Mei Hospital, Liouying
Tainan, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital,Linkou
Taoyuan, , Taiwan
Charing Cross Hospital
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2024-515658-26-00
Identifier Type: CTIS
Identifier Source: secondary_id
KEYNOTE-G23
Identifier Type: OTHER
Identifier Source: secondary_id
MK-3475-G23
Identifier Type: OTHER
Identifier Source: secondary_id
DS8201-793
Identifier Type: -
Identifier Source: org_study_id
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