CompletedPhase 2

Study of Rovalpituzumab Tesirine (SC16LD6.5) for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer

342 participantsStarted 2016-01-25

Plain-language summary

The purpose of this study is to determine the efficacy of rovalpituzumab tesirine as a third-line and later treatment for participants with relapsed or refractory delta-like protein 3 (DLL3) expressing small cell lung cancer (SCLC).

Who can participate

Age range18 Years

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Inclusion criteria

✓. Adult aged 18 years or older
✓. Histologically confirmed SCLC with documented disease progression after at least 2 prior systemic regimens, including at least one platinum-based regimen
✓. DLL3-expressing SCLC based on central immunohistochemistry (IHC) assessment of banked or otherwise representative tumor tissue. Positive is defined as staining in ≥ 1% of tumor cells
✓. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
✓. Minimum life expectancy of at least 12 weeks
✓. Subjects with a history of central nervous system (CNS) metastases must have documentation of stable or improved status based on brain imaging for at least 2 weeks after completion of definitive treatment and within 2 weeks prior to first dose of study drug, off or on a stable dose of corticosteroids
✓. Recovery to Grade 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration

Exclusion criteria

✕. Any significant medical condition, including any suggested by screening laboratory findings 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 (e.g., chronic obstructive pulmonary disease requiring hospitalization within 6 months) or neurological disorder (e.g., seizure disorder active within 6 months)
✕. 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
✕. Recent or ongoing serious infection, including:
✕. Women who are breastfeeding
✕. Systemic therapy with corticosteroids at \>20 mg/day prednisone or equivalent within 1 week prior to the first dose of study drug
✕. History of another invasive malignancy that has not been in remission for at least 3 years. Exceptions to the 3 year limit include 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, unless undergoing retreatment with rovalpituzumab tesirine in the context of this protocol

What they're measuring

Objective Response Rate

Timeframe: up to 122.4 weeks; mean (SD) duration of follow-up was 29.0 (23.77) weeks

Overall Survival

Timeframe: up to 122.4 weeks; mean (SD) duration of follow-up was 29.0 (23.77) weeks

Trial details

NCT IDNCT02674568

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-10-19

Results submitted2019-09-30

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