advanced or metastatic lung cancer small cell lung cancer
Conditions
Interventions
Subjects in the Rova-T arm will receive Rova-T (IV) on Day 1 of each 42-day
cycle, and 8 mg orally of dexamethasone twice daily on Day -1, Day 1 and Day 2
of each cycle in which Rova-T is administer
Sponsors
AbbVie
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Subjects must be an age of 18 years or older, providing written informed consent 2) Histologically or cytologically confirmed advanced or metastatic SCLC with documented first disease progression after or during front-line platinum-based systemic regimen. 3) Tumor must have high DLL3 expression (DLL3high) defined as having > 75% tumor cells staining positive according to the VENTANA DLL3 (SP347) IHC Assay. Archived or fresh tumor material can be used for the DLL3 testing. 4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5) Females of childbearing potential must have a negative serum pregnancy test result at Screening, and a negative urine pregnancy test at randomization. Females of non-childbearing potential (either postmenopausal or permanently surgically sterile) at Screening do not require pregnancy testing.
Exclusion criteria
Exclusion criteria: 1) Any significant medical condition that, in the opinion of the investigator or Sponsor, may place the subject at undue risk from the study, including but not necessarily limited to uncontrolled hypertension and/or diabetes, clinically significant pulmonary disease or neurological disorder (e.g., seizure disorder active within 6 months) 2) 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 (NYHA) Class III - IV within 6 months prior to their first dose of study drug. 3) Subject has known leptomeningeal metastases 4) Subject has Isolated CNS disease progression with no evidence of progression outside of CNS 5) Subject has more than one prior systemic therapy regimen for SCLC (prior systemic maintenance therapy following front-line platinum based regimen, administered as part of clinical trial is allowed)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Overall survival (OS) Timepoints of evaluation of this endpoint: - Overall Survival is defined as the time from the date of randomization to the date of death from any cause (i.e., date of subject*s death - date of randomization +1) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Progression-free survival (PFS) based on the CRAC per RECIST v1.1, - Duration of objective response (DOR) based on the CRAC per RECIST v1.1, - Patient reported outcomes (PROs) Timepoint(s) of evaluation of this endpoint - PFS is based on independent review of tumor assessment, defined as the time from randomization to documented CRAC-assessed disease progression or death from any cause (whichever occurs earlier). - DOR is defined as the time between the date of the first response (CR or PR, whichever is recorded first) to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause, whichever comes first. | — |
Countries
Netherlands
Outcome results
None listed