A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), Versus Treatment of Physician’s Choice (TPC) in Subjects with Relapsed Small Cell Lung Cancer (SCLC) (IDeate-Lung02)

Research summary

This is a global, multicenter, randomized, open-label, Phase 3 study designed to compare the efficacy and safety of I-DXd with the TPC in subjects with relapsed SCLC. Eligible subjects will have received one prior line of platinum-based therapy and at least 75% of whom will have received prior treatment with anti-programmed death-(ligand) 1 (PD-[L]1) antibody. Subjects must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of ≤1. This study is designed to randomize at least 468 subjects in a 1:1 ratio to receive I-DXd (n = 234) or TPC (n = 234; topotecan, amrubicin, or lurbinectedin). Comparator treatments will only be utilized in countries where they are approved in second line for SCLC subjects who progressed on or after platinum-based therapy. At least 50% of subjects treated in the comparator group will receive topotecan. Randomization will be stratified by the following: 1. Prior receipt of an anti-PD-(L)1 antibody (yes versus no) 2. Chemotherapy-free interval, calculated from completion of platinum first-line (1L) therapy to the date of documented radiological progressive disease, of <90 versus ≥90 days 3. Presence or history of asymptomatic brain metastases (regardless of treatment status) (yes versus no) 4. Treatment of physician’s choice (amrubicin versus lurbinectedin versus topotecan) The study will be divided into 3 periods: Screening, Treatment, and Follow-up (which includes the Long-term Follow-up [LTFU]) Periods.

Principal Investigator

Mr Meenali Chitnis

Contact us

Email: latephaseoncology@ouh.nhs.uk

IRAS number

1009904