Faculty, Staff and Student Publications

Language

English

Publication Date

10-1-2025

Journal

Future Oncology

DOI

10.1080/14796694.2025.2565995

PMID

41055143

PMCID

PMC12536792

PubMedCentral® Posted Date

10-7-2025

PubMedCentral® Full Text Version

Post-print

Abstract

Patients with small cell lung cancer (SCLC) have poor prognosis and limited treatment options beyond first-line therapy. B7 homolog 3 (B7-H3) is minimally expressed in normal tissues but highly expressed in SCLC. Ifinatamab deruxtecan (I-DXd), a B7-H3-directed antibody-drug conjugate, has demonstrated promising efficacy and a manageable safety profile in various tumours, including SCLC. IDeate-Lung02 is a global, randomized, open-label Phase 3 study of ~540 patients with relapsed SCLC. Adults with one prior line of platinum-based systemic therapy, ECOG performance status 0-1, and ≥1 measurable lesion (per RECIST 1.1) are eligible for study participation. Patients with asymptomatic untreated or previously treated brain metastases may participate. Patients are randomized 1:1 to receive I-DXd 12 mg/kg intravenously every 3 weeks or treatment of physician's choice (topotecan, amrubicin, or lurbinectedin). Dual primary endpoints are objective response rate (ORR) by blinded independent central review (BICR) and overall survival. Secondary endpoints include ORR by investigator; progression-free survival, duration of response, disease control rate, and time to response, all by BICR and investigator; patient-reported outcomes; and safety. IDeate-Lung02 will ascertain whether I-DXd treatment after only one prior line of systemic treatment improves outcomes for patients with relapsed SCLC compared with topotecan, amrubicin, or lurbinectedin.

Keywords

Humans, Small Cell Lung Carcinoma, Lung Neoplasms, Immunoconjugates, Neoplasm Recurrence, Local, Clinical Trials, Phase III as Topic, Male, Middle Aged, Female, Adult, Randomized Controlled Trials as Topic, Aged, Carbolines, Heterocyclic Compounds, 4 or More Rings, Small cell lung cancer (SCLC), ifinatamab deruxtecan (I-DXd), antibody–drug conjugate (ADC), B7 homolog 3 (B7-H3), DS-7300, MK-2400

Published Open-Access

yes

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