IRB #

STUDY00016887

Title

A Randomized, Open-Label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared with Topotecan for Subjects with Advanced or Metastatic DLL3high Small Cell Lung Cancer (SCLC) who have First Disease Progression During or Following Front-Line Platinum-Based Chemotherapy

Principal Investigator

Jeremy Cetnar

Study Purpose

The purpose of this study is to examine the efficacy, safety and tolerability of rovalpituzumab tesirine (Rova-T) versus topotecan in subjects with advanced or
metastatic DLL3high small cell lung cancer who have first disease progression during or following front-line platinum-based chemotherapy.

Medical Condition(s)

Rova-T, topotecan, small cell lung cancer, DLL3

Eligibility Criteria

Adult age 18 years or older, who have provided written informed consent.

Histologically or cytologically confirmed advanced or metastatic SCLC with documented
first disease progression during or following front-line platinum-based systemic regimen.

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.

Cannot have had more than one prior systemic therapy regimen for SCLC (prior systemic maintenance therapy following front-line platinum based regimen, administered as part of a clinical trial is allowed).

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Your participation in this study may last approximately 12 months

Minors Included

No

Contact

OHSU Knight Cancer Institute Information line 503-494-1080 trials@ohsu.edu

Sponsor

AbbVie Inc

Recruitment End

12/31/2031

Compensation Provided

No


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