Sendai Kousei Hospital | Clinical Trial Management Office
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About
This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab in combination with pemetrexed and platinum chemotherapy in participants with no prior therapy for advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).
Full description
The primary objectives of the study are Progression Free Survival (PFS) and Overall Survival (OS) as first line therapy in participants with programmed death-ligand 1 (PD-L1) TPS <50% and advanced or metastatic NSCLC without actionable genomic alternations.
Eligible participants will be randomized in a 1:1:1 ratio to a) Dato-DXd plus pembrolizumab plus platinum; b) Dato-DXd plus pembrolizumab; or c) pembrolizumab plus pemetrexed plus platinum. Platinum therapy will be either carboplatin or cisplatin at investigator discretion. The study will be divided into three periods: Screening Period (including tissue screening), Treatment Period, and Follow-up Period.
Enrollment
Sex
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Volunteers
Inclusion criteria
Sign and date the Main Informed Consent Form (ICF), prior to the start of any study- specific qualification procedures.
Adults ≥18 at the time the Main ICF is signed.
Has tumor with PD-L1 TPS <50% as determined by PD-L1 IHC 22C3 pharmDx assay by central testing.
Has provided a formalin-fixed tumor tissue sample for the measurement of TROP2 protein expression and for the assessment of other exploratory biomarkers.
Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC.
Has measurable disease based on local imaging assessment using RECIST v1.1.
Histologically documented NSCLC that meets all of the following criteria:
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at screening.
Has an adequate treatment washout period before Cycle 1 Day 1.
Is willing and able to participate in the collection of patient-reported outcomes (PRO) data.
Exclusion criteria
Has received prior systemic treatment for advanced/metastatic NSCLC.
Has received prior treatment with any of the following, including in the adjuvant/neoadjuvant (for NSCLC) setting:
Has received a live vaccine or live-attenuated vaccine 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.
Has spinal cord compression or clinically active untreated central nervous system (CNS) metastases and/or carcinomatous meningitis.
Uncontrolled or significant cardiovascular disease, including:
Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
History of another primary malignancy (beyond NSCLC) except for:
Has a history of severe hypersensitivity reactions to either the drugs or inactive ingredients of Dato-DXd, pembrolizumab, carboplatin, cisplatin or pemetrexed.
Has a history of severe hypersensitivity reactions to other monoclonal antibodies.
Has known human immunodeficiency virus (HIV) infection that is not well controlled.
Has active or uncontrolled hepatitis B or C infection.
Female who is pregnant or breastfeeding or intends to become pregnant.
Any other medical conditions, including cardiac disease or psychological disorders, and/or substance abuse.
Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
Has active, known, or suspected autoimmune disease.
Has clinically significant corneal disease.
Has had an allogeneic tissue/solid organ transplantation.
Has received prior radiotherapy ≤4 weeks of start of study intervention or more than 30 Gy to the lung within 6 months of Cycle 1 Day 1.
Primary purpose
Allocation
Interventional model
Masking
975 participants in 3 patient groups
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Central trial contact
(Asia Sites) Daiichi Sankyo Contact for Clinical Trial Information; (US Sites) Daiichi Sankyo Contact for Clinical Trial Information
Data sourced from clinicaltrials.gov
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