Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)
Lung Cancer
Unknown Primary
18 Years and older, Male and Female
DS1062-A-U303 (primary)
NCI-2023-06122
2022-500802-16-00
Summary
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).
Objectives
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.
Eligibility
- Sign and date the Main Informed Consent Form (ICF), prior to the start of any study- specific qualification procedures.
- Adults â?¥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:
- 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).
- 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.
- 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.
Treatment Sites in Georgia
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