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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

2032-11-24

Last Updated

2026-10-23

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/m\^2 IV Q3W

DRUG

Platinum Chemotherapy

One of the following two will be administered in Arm B: Cisplatin at a dose of 75 mg/m\^2 IV or carboplatin AUC at a dose of 5 mg/mL/min IV Q3W

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.

Locations (246)

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

Lynn Cancer Institute Center

Boca Raton, 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

Cleveland Clinic Florida - Weston

Weston, Florida, United States

Piedmont Cancer Institute OneOncology

Atlanta, Georgia, United States

The Queens Medical Center

Honolulu, Hawaii, United States

Hope and Healing Cancer Services

Hinsdale, Illinois, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Logan Health Research

Kalispell, Montana, United States

Renown Regional Medical Center

Reno, Nevada, United States

Clinical Research Alliance

Westbury, New York, United States

FirstHealth Cancer Center

Pinehurst, North Carolina, United States

Carolina Cancer Research Center

Wilson, 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

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, Argentina

Instituto de Investigaciones Clinicas Cordoba S.A.

Córdoba, Argentina

Centro de Investigacion Pergamino SA

Pergamino, Argentina

Hospital Universitario Austral

Pilar, Argentina

Sanatorio Britanico S.A.

Rosario, 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

UZA

Edegem, Belgium

Grand Hôpital de Charleroi-Les Viviers

Gilly, Belgium

Chu Helora Hospital La Louvière Site Jolimont

La Louvière, Belgium

Chu de Liăge

Liège, Belgium

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

Hospital Nossa Senhora Da Conceição

Porto Alegre, Brazil

Centro de Tratamento Oncologico (CTO)

Ribeirão Preto, Brazil

Hospital das Clínicas FMRP-USP

Ribeirão Preto, Brazil

Oncoclínicas Rio de Janeiro

Rio de Janeiro, Brazil

Instituto Dâor Pesquisa E Ensino - Rio de Janeiro

Rio de Janeiro, 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

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, Chile

Centro de Oncologia de Precision

Santiago, Chile

Hospital Clinico Universidad de Chile

Santiago, Chile

Centro de Investigacion Clinica Bradford Hill

Santiago, Chile

Clinica Redsalud Vitacura

Santiago, Chile

Beijing Cancer Hospital

Beijing, China

China-Japan Friendship hospital

Beijing, China

Jilin Cancer Hospital

Changchun, 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, China

Liaoning Cancer Hospital & Institute

Shenyang, China

Shanxi Provincial Cancer Hospital

Taiyuan, China

Tianjin Medical University General Hospital

Tianjin, China

Hubei Cancer Hospital

Wuhan, 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, China

CHU Angers - Hôpital Larrey

Angers, France

Institut Bergonié

Bordeaux, France

And 146 more locations on ClinicalTrials.gov

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 (246)