A Study of Rovalpituzumab Tesirine (SC16LD6.5) in the Frontline Treatment of Patients With Extensive Stage Small Cell Lung Cancer
The purpose of the study is to test the effect of rovalpituzumab tesirine in the frontline treatment of small cell lung cancer (SCLC).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Mar 12, 2020 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- AbbVie
- Interventions being studied
- Drug: Rovalpituzumab Tesirine; Drug: Cisplatin; Drug: Etoposide
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of ColoradoAurora, Colorado
- Rocky Mountain Cancer CentersDenver, Colorado
- Cancer Institute of FloridaOrlando, Florida
- Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland
- Washington UniversitySt Louis, Missouri
- Oncology Hematology CareCincinnati, Ohio
- University Hospital of ClevelandCleveland, Ohio
- Cleveland ClinicCleveland, Ohio
- University of PittsburghPittsburgh, Pennsylvania
- Texas OncologyFort Worth, Texas
- Texas OncologySan Antonio, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 12, 2020. Always confirm current availability with the study team.