Last updated 8 days ago
Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations
740 patients around the world
Available in Argentina, Chile, United States, Spain
The primary objective of the study is to compare the efficacy of Dato-DXd and
pembrolizumab with pembrolizumab alone in terms of either Progression Free Survival (PFS)
by BICR or Overall Survival (OS) for participants with advanced or metastatic NSCLC with
non-squamous histology without actionable genomic alterations whose tumor has high
programmed death-ligand 1 (PD-L1) expression (tumor proportion score; TPS ≥50%) and who
have not previously received systemic therapy for advanced or metastatic NSCLC.
Eligible participants will be randomized in a 1:1 ratio to the control arm (pembrolizumab
alone) or the experimental arm (Dato-DXd and pembrolizumab). The study will be divided
into 4 periods: Tissue Screening Period, Screening Period, Treatment Period, and
Follow-up Period.
Daiichi Sankyo, Inc.
15Research sites
740Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Participants eligible for inclusion in the study must meet all inclusion criteria within 28 days of randomization into the study.Sign and date the Tissue Screening and Main Informed Consent Forms, prior to the start of any study-specific qualification procedures.Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time of informed consent.Histologically documented NSCLC that meets all of the following criteria: Stage IIIB or IIIC disease and not candidates for surgical resection or definitive chemoradiation, or Stage IV NSCLC disease at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition). Participants with early-stage NSCLC who have relapsed should be restaged during screening to ensure their eligibility for the study.Documented negative test results for epidermal growth factor receptor (EGFR), lymphoma kinase (ALK), and proto-oncogene1 (ROS1) actionable genomic alterations based on analysis of tumor tissue.No known actionable genomic alterations in neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), rearranged during transfection (RET), mesenchymal-epithelial transition factor (MET), or other actionable driver kinases with locally approved therapies.Has provided a formalin-fixed tumor tissue sample for the measurement of trophoblast cell surface protein 2 (TROP2) protein expression and for the assessment of other exploratory biomarkers.Tumor has high programmed death receptor-1 (PD-L1) expression (TPS ≥50%) as determined by PD-L1 immunohistochemistry (IHC) 22C3 pharmDx assay by central testing (minimum of 6 slides).Has an adequate treatment washout period before Cycle 1 Day 1.Measurable disease based on local imaging assessment using RECIST Version 1.1.Has left ventricular ejection fraction (LVEF) ≥50% by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before randomization.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at screening.Has a life expectancy of at least 3 months.Adequate bone marrow function within 7 days before randomization.Participants with a history of Class 2 to 4 CHF prior to screening, must have returned to Class 1 CHF and have LVEF ≥50% (by either an ECHO or MUGA scan within 28 days before randomization) in order to be eligible.
- Has received prior systemic treatment for advanced or metastatic NSCLC.Has received prior treatment for NSCLC with any of the following, including in the adjuvant/neoadjuvant setting: Any agent, including an antibody-drug conjugate, containing a chemotherapeutic agent targeting topoisomerase I.Has spinal cord compression or active and untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable.Has received prior radiotherapy ≤4 weeks of start of study intervention or more than 30 Gy (unit of ionizing radiation dose in the International System of Units) to the lung within 6 months of Cycle 1 Day 1.History of another primary malignancy (beyond NSCLC) except for: Malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of study treatment and of low potential risk for recurrence.Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis including radiation pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.Clinically severe pulmonary compromise, as judged by the investigator, resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement or prior complete pneumonectomy.Uncontrolled or significant cardiovascular disease, including: Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) interval >470 msec regardless of sex (based on the average of the 12-lead electrocardiogram determination at screening).Clinically significant corneal disease.Has received a live vaccine or live-attenuated vaccine (messenger ribonucleic acid and replication-incompetent adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of study drug. For any participant receiving an approved severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine, please follow the vaccine label and/or local guidance.Active, known, or suspected autoimmune disease (has an active autoimmune disease that has required systemic treatment in the past 2 years).Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosage >10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy ≤7 days prior to the first dose of study drug.Has known human immunodeficiency virus (HIV) infection that is not well controlled.Has an active hepatitis or uncontrolled hepatitis B or active hepatitis C infection.Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.Had an allogeneic tissue/solid organ transplant.Has a history of severe hypersensitivity reactions to either the drug or inactive ingredients (including but not limited to polysorbate 80) of Dato-DXd or pembrolizumab.
Sites
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
Recruiting
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Recruiting
Fundación CENIT para la Investigación en Neurociencias
Recruiting
Sanatorio Parque - Rosario
Recruiting
Sanatorio Británico - Rosario
Recruiting
Instituto de Oncología de Rosario - IOR
Recruiting
Hospital Privado de la Comunidad
Recruiting
Centro de Investigación Pergamino SA
Recruiting
Centro de Investigaciones Clínicas Viña Del Mar
Recruiting
Hospital Universitario Fundacion Jimenez Diaz
Recruiting
StudyTROPION-Lung08
SponsorDaiichi Sankyo, Inc.
Study typeInterventional
Conditions
Non-small cell lung carcinomaLung cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05215340
