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)
Progression Free Survival by Blinded Independent Central Review — From date of randomization to the date of radiographic disease progression or death due to any cause, up to approximately 54 months PFS is defined as the time interval from the date of randomization to the date of radiographic disease progression or death due to any cause. Tumor response will be determined by BICR assessment of tumor scans using RECIST v1.1.
Trial sites (242)
Facility
City
Region
Status
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.
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.
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