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NCT06899126PHASE3Recruiting

Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer

Daiichi Sankyo

Start Date

10/24/2025

Completion Date

11/24/2032

Summary

This clinical trial is designed to assess the efficacy and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS \<50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced/metastatic setting.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Sign and date the Tissue Screening ICF, prior to any Tissue Screening procedure. Sign and date the Main ICF, prior to the start of any trial-specific qualification procedures. Sign and date the Optional PGx ICF (included in the Main 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 the local test results obtained using validated or approved tests as required per local regulation) 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 non-squamous NSCLC 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 if their disease has progressed at least 6 months after 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: 1. Has a medical history of MI within 6 months before randomization/enrollment or symptomatic CHF (NYHA Class II to Class IV). Participants with troponin levels above the ULN at Screening (as defined by the manufacturer) and without any MI-related symptoms must be ruled out for MI. It is highly recommended that the investigator refer such participants for a cardiologic consultation during the Screening Period. 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 clinically severe pulmonary compromise resulting from intercurrent, pulmonary illnesses including, but not limited to: 1. Any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe COPD, restrictive lung disease, pleural effusion). 2. Any auto immune, connective tissue, or inflammatory disorders with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis). Severe conditions are those defined as impacting daily activities and/or requiring use of supplemental oxygen. 5. Had a prior complete pneumonectomy.

Interventions

DRUG

Trastuzumab Deruxtecan

DRUG

pembrolizumab

DRUG

Pemetrexed

DRUG

Platinum Chemotherapy

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Conditions

Non-small Cell Lung Cancer

Locations

Alaska Oncology & Hematology, LLC

Anchorage, Alaska 99508

United States

Orange Coast Memorial Medical Center Fountain Valley

Fountain Valley, California 97208

United States

California Research Institute

Los Angeles, California 90027

United States

Los Angeles Cancer Network (LACN)

Los Angeles, California 91204

United States

Providence Medical Foundation

Santa Rosa, California 95403

United States

Bay Pines VA Healthcare System

Bay Pines, Florida 33744

United States

Lynn Cancer Institute Center

Boca Raton, Florida 33486

United States

Holy Cross Hospital

Fort Lauderdale, Florida 33308

United States

Mid-Florida Hematology & Oncology Centers, P.A.

Orange City, Florida 33763

United States

BRCR Global Plantation

Plantation, Florida 33321

United States

Cleveland Clinic Florida - Weston

Weston, Florida 33331

United States

Piedmont Cancer Institute OneOncology

Atlanta, Georgia 30318

United States

The Queens Medical Center

Honolulu, Hawaii 96813-2402

United States

Hope and Healing Cancer Services

Hinsdale, Illinois 60521

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02216

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Logan Health Research

Kalispell, Montana 59901

United States

Renown Regional Medical Center

Reno, Nevada 89502

United States

Clinical Research Alliance

Westbury, New York 11590

United States

FirstHealth Cancer Center

Pinehurst, North Carolina 28374

United States

Carolina Cancer Research Center

Wilson, North Carolina 27893

United States

Gabrail Cancer Center

Canton, Ohio 44718

United States

St. Charles Health System

Bend, Oregon 97701

United States

University of Texas M. D. Anderson Cancer Center

Houston, Texas 77030

United States

Lumi Research

Kingwood, Texas 77339

United States

Summit Cancer Treatment Center

Spokane, Washington 99208

United States

CINME - Centro De Investigaciones Metabolicas

Buenos Aires,

Argentina

Hospital Italiano de Buenos Aires

Buenos Aires,

Argentina

Instituto Argentino de Diagnostico y Tratamiento

Buenos Aires,

Argentina

Instituto de Investigaciones Metabolicas (IDIM)

Buenos Aires,

Argentina

Centro de Investigaciones Medicas y Desarrollo LC SRL (LC Investigacion)

Ciudad Autonoma Buenos Aires, 1113

Argentina

Instituto de Investigaciones Clinicas Cordoba S.A.

Córdoba, 5000

Argentina

Centro de Investigacion Pergamino SA

Pergamino,

Argentina

Hospital Universitario Austral

Pilar,

Argentina

Sanatorio Britanico S.A.

Rosario, 2000

Argentina

Instituto de Oncologia de Rosario

Rosario,

Argentina

Instituto Medico de la Fundacion Estudios Clinicos

Rosario,

Argentina

Sanatorio Parque S.A.

Rosario,

Argentina

Instituto San Marcos

San Juan,

Argentina

Grand Hôpital de Charleroi-Les Viviers

Gilly, 6060

Belgium

Chu Helora Hospital La Louvière Site Jolimont

La Louvière, 7100

Belgium

Chu de Liăge

Liège,

Belgium

CHU Helora-Hospital de Mons

Mons,

Belgium

Hospital de Cancer de Barretos - Fundacao Pio XII

Barretos, 14784-400

Brazil

Centro de Pesquisas Clinica Reichow

Blumenau, 89010-340

Brazil

CIONC-Centro Integrado de Oncologia de Curitiba

Curitiba, 80810-050

Brazil

CRIO - Centro Regional Integrado de Oncologia

Fortaleza, 60336-045

Brazil

Liga Norte-Rio-Grandense Contra o Câncer

Natal, 59075-740

Brazil

Hospital Ernesto Dornelles

Porto Alegre, 90035-170

Brazil

Hospital São Lucas da PUCRS

Porto Alegre, 90619-000

Brazil

Hospital Nossa Senhora Da Conceição

Porto Alegre,

Brazil

Centro de Tratamento Oncologico (CTO)

Ribeirão Preto, 14026-596

Brazil

Hospital das Clínicas FMRP-USP

Ribeirão Preto, 14051-140

Brazil

Oncoclínicas Rio de Janeiro

Rio de Janeiro, 20230-130

Brazil

Instituto Dâor Pesquisa E Ensino - Rio de Janeiro

Rio de Janeiro,

Brazil

Obras Sociais Irmã Dulce - Hospital Santo Antônio

Salvador, 40.414-120

Brazil

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

Santo André, 09060-870

Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

Sao Jose Rio Preto, 15090-000

Brazil

Icesp - Instituto Do Câncer Do Estado de São Paulo Octavio Frias de Oliveira

São Paulo,

Brazil

Centro Paulista de Oncologia S A

Vila Olímpia,

Brazil

Biocenter

Concepción,

Chile

Orlandi Oncologia

Santiago, 7500713

Chile

Centro de Oncologia de Precision

Santiago, 7560908

Chile

Hospital Clinico Universidad de Chile

Santiago, 8380456

Chile

Centro de Investigacion Clinica Bradford Hill

Santiago, 8420383

Chile

Clinica Redsalud Vitacura

Santiago,

Chile

Beijing Cancer Hospital

Beijing, 100142

China

China-Japan Friendship hospital

Beijing,

China

Jilin Cancer Hospital

Changchun, 130000

China

The First Hospital of Jilin University

Changchun,

China

Hunan Cancer Hospital

Changsha,

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

Anhui Provincial Hospital

Hefei,

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

The First Hospital of China Medical University

Shenyang, 110001

China

Liaoning Cancer Hospital & Institute

Shenyang,

China

Shanxi Provincial Cancer Hospital

Taiyuan,

China

Tianjin Medical University General Hospital

Tianjin,

China

Hubei Cancer Hospital

Wuhan, 430079

China

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

Wuhan,

China

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan,

China

Xiangyang Central Hospital

Xiangyang,

China

Henan Cancer Hospital

Zhengzhou, 450003

China

CHU Angers - Hôpital Larrey

Angers, 49933

France

Institut Bergonié

Bordeaux,

France

Hăpital Ambroise Pară

Boulogne-Billancourt,

France

Hospices Civils de Lyon

Bron, 69677

France

Centre Hospitalier Intercommunal de Créteil

Créteil, 94010

France

Centre Georges Francois Leclerc

Dijon, 21079

France

Hopital Albert Calmette - CHU Lille

Lille,

France

Centre Leon Berard

Lyon,

France

Assistance Publique-Hôpitaux de Marseille

Marseille, 13915

France

Clinique Clementville

Montpellier, 34070

France

Hăpital Privă Du Confluent

Nantes,

France

Hopital Bichat - Claude Bernard

Paris, 75018

France

Chu Nantes - Hăpital Guillaume Et Renă Laă Nnec

Saint-Herblain,

France

Institut de Cancerologie de L'Ouest

Saint-Herblain,

France

Hăpital Foch

Suresnes,

France

Hopital Larrey

Toulouse, 31059

France

Universitatsmedizin Mainz

Essen, 60590

Germany

Klinikum Esslingen GmbH

Esslingen am Neckar, 73730

Germany

Universitaetsmedizin Mannheim

Manheim,

Germany

Universtitaetsklinikum Essen

Nordrhein Westfalen,

Germany

General Hospital of Athens of Chest Diseases "SOTIRIA"

Athens, 11527

Greece

'Henry Dynant' Hospital Center

Athens,

Greece

National and Kapodistrian University of Athens (Nkua)-University General Hospital Attikon

Athens,

Greece

University General Hospital of Larissa

Larissa,

Greece

Metropolitan Hospital

Neo Faliro, 18547

Greece

St Luke's Hospital

Panórama, 55236

Greece

University General Hospital of Patras

Pátrai,

Greece

Special Anticancer Hospital of Piraeus 'Metaxa'

Piraeus,

Greece

General Hospital Papageorgiou

Thessaloniki, 57010

Greece

Interbalkan Hospital of Thessaloniki

Thessaloniki,

Greece

Queen Elizabeth Hospital

Hong Kong,

Hong Kong

The University of Hong Kong

Hong Kong,

Hong Kong

The Chinese University of Hong Kong

Shatin,

Hong Kong

Gleneagles Hospital Hong Kong

Wong Chuk Hang,

Hong Kong

Mazumdar Shaw Medical Center

Bangalore,

India

All India Institute of Medical Sciences

Bhubaneswar, 751019

India

Narayana Superspeciality Hospital

Howrah,

India

Yenepoya Medical College Hospital

Mangalore,

India

Deenanath Mangeshkar Hospital and Research Centre

Pune, 411004

India

Nirmal Hospital Private Limited

Surat,

India

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi Irccs

Bologna,

Italy

Fondazione del Piemonte per l'Oncologia IRCCS Candiolo

Candiolo,

Italy

Ospedale Santa Croce

Fano, 61032

Italy

Istituto Nazionale Per La Ricerca Sul Cancro Di Genova

Genova,

Italy

Presidio Ospedaliero Di Livorno

Livorno,

Italy

Ospedale San Raffaele

Milan, 20132

Italy

Humanitas Istituto Clinico Catanese

Misterbianco, 95045

Italy

Azienda Ospedaliero-Universitaria S.Luigi Gonzaga

Orbassano, 10043

Italy

Azienda Ospedaliera S.Giovanni Addolorata

Roma, 00184

Italy

Istituto Nazionale Tumori Regina Elena IRCCS

Roma,

Italy

Centro Ricerche Cliniche di Verona s.r.l.

Verona,

Italy

Saitama Medical University International Medical Center

Hidaka-shi,

Japan

Kansai Medical University Hospital

Hirakata-shi,

Japan

Hirosaki University Hospital

Hirosaki-shi, 036-8563

Japan

National Cancer Center Hospital East

Kashiwa-shi, 277-8577

Japan

St. Marianna University Hospital

Kawasaki-shi, 220-0011

Japan

Hospital of the University of Occupational and Environmental Health

Kitakyushu-shi,

Japan

Saiseikai Kumamoto Hospital

Kumamoto,

Japan

Kurume University Hospital

Kurume-shi, 810-0001

Japan

Matsusaka Municipal Hospital

Matsusaka-shi,

Japan

NHO Okayama Medical Center

Okayama, 700-0815

Japan

Osaka City General Hospital

Osaka, 533-0033

Japan

Osaka International Cancer Institute

Osaka, 541-0045

Japan

Toho University Omori Medical Center

Ōta-ku,

Japan

NHO Kinki-Chuo Chest Medical Center

Sakaishi,

Japan

Keijinkai Teine Keijinkai Hospital

Sapporo,

Japan

Tokyo Medical University Hospital

Shinjuku-ku, 220-0004

Japan

Shizuoka Cancer Center

Sunto-gun,

Japan

Ehime University Hospital

Toon-shi, 162-0821

Japan

Fujita Health University Hospital

Toyoake-shi, 470-1192

Japan

Wakayama Medical University Hospital

Wakayama,

Japan

Kanagawa Cancer Center

Yokohama,

Japan

Tottori University Hospital

Yonago-shi,

Japan

Gleneagles Hospital Penang

Jalan Pangkor, 10050

Malaysia

Hospital Kuala Lumpur

Kuala Lumpur,

Malaysia

Hospital Tengku Ampuan Afzan

Kuantan,

Malaysia

Beacon Hospital Sdn Bhd

Petaling Jaya,

Malaysia

Wojewodzki Szpital Im. SW. Ojca Pio W Przemyslu

Rzeszów,

Poland

Hospital da Luz

Lisbon, 1500-650

Portugal

Unidade Local de Saude de Santa Maria, E.P.E. - Hospital Pulido Valente

Lisbon,

Portugal

Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António

Porto, 4099-001

Portugal

Hospital CUF Porto

Porto, 4100-180

Portugal

Delta Health Care S.R.L

Bucharest, 14142

Romania

Colentina Hospital

Bucharest,

Romania

Memorial Healthcare International S R L

Bucharest,

Romania

Institutul Oncologic

Cluj-Napoca, 400015

Romania

Spitalul Clinic Militar de Urgenta Dr. "Constantin Papilian" Cluj-Napoca

Cluj-Napoca, 400132

Romania

Centrul de Oncologie Sfantul Nectarie Craiova

Craiova, 200347

Romania

Institutul Regional de Oncologie Lasi

Lasi, 700483

Romania

S.C R.T.C Radiology Therapeutic Center S.R.L

Otopeni,

Romania

Spitalul Municipal Ploiesti

Ploieşti,

Romania

Chungbuk National University Hospital

Cheongju-si, 28644

South Korea

National Cancer Center

Goyang-si, 10408

South Korea

Gyeongsang National University Hospital

Jinju,

South Korea

CHA Bundang Medical Center, CHA University

Seongnam, 13496

South Korea

Seoul National University Bundang Hospital

Seongnam, 13620

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 3722

South Korea

Asan Medical Center

Seoul,

South Korea

Samsung Medical Center

Seoul,

South Korea

The Catholic University of Korea, St. Vincent's Hospital

Suwon, 16247

South Korea

Hospital del Mar

Barcelona, 08003

Spain

Hospital Clinic de Barcelona

Barcelona, 08036

Spain

ICO l'Hospitalet - Hospital Duran i Reynals

Barcelona, 8908

Spain

Hospital Universitari Dexeus

Barcelona,

Spain

Hospital Universitari Vall d'Hebron - VHIO

Barcelona,

Spain

Hospital Provincial de Castellon

Castellion,

Spain

Complejo Hospitalario Universitario Insular-Materno Infantil

Las Palmas de Gran Canaria, 35016

Spain

Hospital Universitario Lucus Augusti

Lugo, 27003

Spain

Hospital General Universitario Gregorio Marañon

Madrid, 28007

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Hospital Universitario Clinico San Carlos

Madrid,

Spain

Hospital Clinico Universitario Virgen de la Victoria

Málaga, 29010

Spain

Hospital Regional Universitario de Malaga

Málaga,

Spain

Hospital Universitario Central de Asturias

Oviedo,

Spain

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, 15706

Spain

Hospital Universitario Nuestra Señora de Valme

Seville, 41014

Spain

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

National Taiwan University Cancer Center

Taipei, 106

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 City,

Taiwan

Siriraj Hospital

Bangkok, 10700

Thailand

Phramongkutklao Hospital

Bangkok,

Thailand

Vajira Hospital

Dusit, 10300

Thailand

Songklanagarind Hospital

Hat Yai, 90110

Thailand

Chulabhorn Hospital

Laksi,

Thailand

Rajavithi Hospital

Rajathevee,

Thailand

Medical Park Seyhan Hospital

Adana,

Turkey (Türkiye)

Gulhane Training and Research Hospital

Ankara, 6010

Turkey (Türkiye)

Hacettepe University Medical Faculty

Ankara, 6100

Turkey (Türkiye)

Medipol University Medical Faculty

Istanbul, 34147

Turkey (Türkiye)

Eastbourne District General Hospital

Eastbourne, BN21 2UD

United Kingdom

Charing Cross Hospital

London,

United Kingdom

Altnagelvin Area Hospital

Londonderry, BT47 6SB

United Kingdom

Nottingham University Hospitals City Campus

Nottingham, NG5 1PB

United Kingdom