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RECRUITING

NCT06899126

PHASE3

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

Sponsor: Daiichi Sankyo

View on ClinicalTrials.gov

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.

Official title: A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination With Pembrolizumab Versus Platinum-based Chemotherapy in Combination With Pembrolizumab, as First-line Therapy in Participants With Locally Advanced Unresectable or Metastatic HER2 Overexpressing and PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer (DESTINY-Lung06)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

686

Start Date

2025-10-24

Completion Date

2032-07-05

Last Updated

2026-01-08

Healthy Volunteers

Conditions

Non-small Cell Lung Cancer

Interventions

DRUG

Trastuzumab Deruxtecan

T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)

DRUG

pembrolizumab

pembrolizumab will be administered at a dose of 200 mg IV Q3W

DRUG

Pemetrexed

Pemetrexed will be administered at a dose of 500 mg/m2 IV Q3W

DRUG

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

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 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: 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 should have a cardiologic consultation during the Screening Period to rule out MI. 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.

Locations (100)

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (100)