A Study of Rovalpituzumab Tesirine (SC16LD6.5) in the Frontline Treatment of Patients With Extensive Stage Small Cell Lung Cancer

Stopped early · Phase 1

Conditions studied: Small Cell Lung Cancer

In brief

The purpose of the study is to test the effect of rovalpituzumab tesirine in the frontline treatment of small cell lung cancer (SCLC).

Key facts

Study ID

NCT02819999

Run by

AbbVie

People needed

28

Starts

2016-10-01

Expected to finish

2019-05-31

Last updated by the study team

2020-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years with histologically- or cytologically-confirmed, extensive-stage, chemotherapy-naïve SCLC
• DLL3-expressing SCLC based on central immunohistochemistry (IHC) assessment. Positive is defined as staining in ≥75% of tumor cells.
• Eastern Cooperative Oncology Group performance status of 0 or 1.
• Minimum life expectancy of at least 12 weeks.
• Recovery to Grade 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug.
• Satisfactory laboratory parameters within defined parameters (ANC, platelet count, Hb, total bilirubin, ALT, AST and GFR)
• Subjects with a history of CNS metastases must have completed definitive treatment prior to first dose of study treatment, off or on a stable dose of corticosteroids
• Use of effective contraception method during and for 1 year following study drug dosing if female of childbearing potential or sexually active male

You may not qualify if…

• Prior systemic chemotherapy, small molecule inhibitors, immune checkpoint inhibitors, other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other anticancer therapy for the treatment of (limited or extensive) SCLC.
• Any significant medical condition, that, in the opinion of the investigator or sponsor, may place the subject at undue risk from the study.
• Documented history of a cerebral vascular, 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.
• Recent or ongoing serious infection.
• Women who are pregnant or breastfeeding.
• History of another invasive malignancy that has not been in remission for at least 3 years. Exceptions: nonmelanoma skin cancer, curatively treated localized prostate cancer, and cervical cancer in situ on biopsy or squamous intraepithelial lesion on PAP smear.
• Prior exposure to a pyrrolobenzodiazepine (PBD)-based drug, or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation

Where it is running

• University of Colorado — Aurora, Colorado, United States
• Rocky Mountain Cancer Centers — Denver, Colorado, United States
• Cancer Institute of Florida — Orlando, Florida, United States
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• Washington University — St Louis, Missouri, United States
• Oncology Hematology Care — Cincinnati, Ohio, United States
• University Hospital of Cleveland — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Texas Oncology — Fort Worth, Texas, United States
• Texas Oncology — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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