TROPION-Lung01 Study Design and Baseline demographics
Daiichi-Sankyo
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Introduction and Study Design
Dato-DXd is a TROP2-directed ADC consisting of a humanized anti-TROP2 IgG1 monoclonal antibody covalently linked to a highly potent
topoisomerase I inhibitor payload via a plasma-stable, tumor-selective, tetrapeptide-based cleavable linker¹
⚫ In the phase 1 TROPION-Pan Tumor01 study, Dato-DXd showed promising efficacy in patients with actionable genomic alterations2
TROPION-Lung05 (NCT04484142) is a phase 2, single-arm study evaluating Dato-DXd in patients with advanced or metastatic NSCLC
with actionable genomic alterations that progressed on or after targeted therapy and platinum-based chemotherapy
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Endpointsa
Primary: ORR by BICR
Secondary:
Screening
Key inclusion criteria
Treatment
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Stage IIIB, IIIC, or IV NSCLC
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Presence of ≥1 actionable genomic alteration (EGFR, ALK, ROS1,
Dato-DXd
NTRK, BRAF, MET exon 14 skipping, or RET)
6 mg/kg
Q3W
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By investigator: ORR
• ECOG PS of 0 or 1
• ≥1 line of targeted therapy
• 1 or 2 prior cytotoxic agent-containing therapies in the metastatic setting
By BICR and investigator: DOR,
DCR, CBR, PFS, TTR
OS, safety, PK, immunogenicity
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Radiographic disease progression after targeted therapy
ADC, antibody-drug conjugate, BICR, blinded independent central review, CBR, clinical benefit rate; Dato-DXd, datopotamab deruxtecan, DCR, disease control rate; DOR, duration of response, ECOG PS, Eastern Cooperative Oncology
Group performance status; IgG1, immunoglobulin G1; NSCLC, non-small cell lung cancer; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PK, pharmacokinetics; Q3W, every 3 weeks; TROP2,
trophoblast cell-surface antigen 2; TTR, time to response.
*The primary completion date will occur when all patients have had either a minimum of 9 months of follow-up after the start of study treatment or have discontinued from the study.
1. Okajima D, et al. Mol Cancer Ther. 2021;20:2329-2340.2. Shimizu T, et al. J Clin Oncol. Published online June 16, 2023.
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