Last updated 10 days ago
Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer
686 patients around the world
Available in United States, Brazil
Daiichi Sankyo
9Research sites
686Patients 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
- 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.Sign and date the Pregnant Partner ICF, if applicable.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.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).Participants with mixed histology are eligible if adenocarcinoma is the predominant histology.Mixed tumors will be classified based on the predominant cell type.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.Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I.HER2-targeted antibody-based anticancer therapy.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.
- 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.Has a QTc prolongation to >480 ms based on the average of the Screening triplicate 12-lead ECG.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.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.).Had a prior complete pneumonectomy.
Sites
Instituto Argentino de Diagnóstico y Tratamiento - IADT
Recruiting
CIONC - Centro Integrado de Oncología de Curitiba
Recruiting
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica
Recruiting
Hospital Ernesto Dornelles
Recruiting
Clinica de Oncologia Reichow
Recruiting
CTO - Centro de Tratamento Oncológico
Recruiting
Hospital da Criança Santo Antônio
Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Recruiting
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Recruiting
StudyDESTINY-Lung06
SponsorDaiichi Sankyo
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06899126
