The purpose of this randomized, open-label, 2-arm, Phase 3 study is to assess the efficacy, safety and tolerability of an active drug versus topotecan in participants with advanced or metastatic Small Cell Lung Cancer (SCLC) with high levels of delta-like protein 3 (DLL3) and who have first disease progression during or following front-line platinum-based chemotherapy.
18 Years and older.
- Participant must have histologically or cytologically confirmed advanced or metastatic
Small Cell Lung Cancer (SCLC) with documented first disease progression during or
following front-line platinum-based systemic regimen
- Tumor must have high Delta-like protein 3 (DLL3) expression defined as having ≥ 75%
tumor cells staining positive according to the VENTANA DLL3 (SP347) IHC Assay.
- Participant must have measurable disease, as defined per Response Evaluation Criteria
in Solid Tumors (RECIST) version 1.1.
- Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status
of 0 or 1.
- Participant must have recovery to Grade 0 or 1 of any clinically significant toxicity
(excluding alopecia) prior to initiation of study drug administration.
- Participant has a documented history of a cerebral vascular event (stroke or transient
ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms
consistent with New York Heart Association Class (NYHA) III - IV within 6 months prior
to their first dose of study drug.
- Participant has known leptomeningeal metastases.
- Participant has received more than one prior systemic therapy regimen for SCLC.
- Participant had a serious infection within 2 weeks prior to randomization, including
any Grade 3 or higher viral, bacterial, or fungal infection.
- Participant has a history of active malignancies other than SCLC within the past 2
years prior to study entry, with the exception of in situ cancer which was curatively
- Participant had prior exposure to topotecan, irinotecan or any other topoisomerase I