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Clinical Trials in the UK / NCT06899126
Recruiting Phase 3

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

NCT06899126 · tracked via the Priya Life Science UK tracker
Sponsor
Daiichi Sankyo
Phase
Phase 3
Started
2025-10-24
Last updated
2026-09-15

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Trastuzumab DeruxtecanpembrolizumabPemetrexedPlatinum Chemotherapy

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/m\^2 IV Q3W

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

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (242)

FacilityCityRegionStatus
Alaska Oncology & Hematology, LLC Anchorage Alaska Recruiting
Orange Coast Memorial Medical Center Fountain Valley Fountain Valley California Recruiting
California Research Institute Los Angeles California Recruiting
Los Angeles Cancer Network (LACN) Los Angeles California Recruiting
Providence Medical Foundation Santa Rosa California Recruiting
Bay Pines VA Healthcare System Bay Pines Florida Recruiting
Lynn Cancer Institute Center Boca Raton Florida Recruiting
Holy Cross Hospital Fort Lauderdale Florida Recruiting
Mid-Florida Hematology & Oncology Centers, P.A. Orange City Florida Recruiting
BRCR Global Plantation Plantation Florida Recruiting
Cleveland Clinic Florida - Weston Weston Florida Recruiting
Piedmont Cancer Institute OneOncology Atlanta Georgia Recruiting
The Queens Medical Center Honolulu Hawaii Recruiting
Hope and Healing Cancer Services Hinsdale Illinois Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Logan Health Research Kalispell Montana Recruiting
Renown Regional Medical Center Reno Nevada Recruiting
Clinical Research Alliance Westbury New York Active Not Recruiting
FirstHealth Cancer Center Pinehurst North Carolina Recruiting
Carolina Cancer Research Center Wilson North Carolina Recruiting
Gabrail Cancer Center Canton Ohio Recruiting
St. Charles Health System Bend Oregon Recruiting
University of Texas M. D. Anderson Cancer Center Houston Texas Recruiting
Lumi Research Kingwood Texas Recruiting
Summit Cancer Treatment Center Spokane Washington Recruiting
CINME - Centro De Investigaciones Metabolicas Buenos Aires Argentina Recruiting
Hospital Italiano de Buenos Aires Buenos Aires Argentina Recruiting
Instituto Argentino de Diagnostico y Tratamiento Buenos Aires Argentina Recruiting
Instituto de Investigaciones Metabolicas (IDIM) Buenos Aires Argentina Recruiting
Centro de Investigaciones Medicas y Desarrollo LC SRL (LC Investigacion) Ciudad Autonoma Buenos Aires Argentina Recruiting
Instituto de Investigaciones Clinicas Cordoba S.A. Córdoba Argentina Recruiting
Centro de Investigacion Pergamino SA Pergamino Argentina Recruiting
Hospital Universitario Austral Pilar Argentina Recruiting
Sanatorio Britanico S.A. Rosario Argentina Recruiting
Instituto de Oncologia de Rosario Rosario Argentina Recruiting
Instituto Medico de la Fundacion Estudios Clinicos Rosario Argentina Recruiting
Sanatorio Parque S.A. Rosario Argentina Recruiting
Instituto San Marcos San Juan Argentina Recruiting
UZA Edegem Belgium Recruiting

+ 202 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06899126 on ClinicalTrials.gov ↗ ← All trials in the UK