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WithdrawnPhase 3NCT03334487
Official study title

Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer

Study summary

A single-arm, open-label study to assess the overall safety of rovalpituzumab tesirine in participants with relapsed or refractory delta-like protein 3 (DLL3) expressing small cell lung cancer by evaluating the frequency of high grade (\>= Grade 3) select treatment-emergent adverse events (TEAEs).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDexamethasone and Rovalpituzumab tesirine

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC) · Recurrent or relapsed · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 26, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Withdrawn

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?60 U.S. locations

Locations may change over time.

Who runs it?AbbVie

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
AbbVie
Interventions being studied
Drug: Dexamethasone; Drug: Rovalpituzumab tesirine
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Small cell lung cancer (SCLC)→
Disease setting
Recurrent or relapsed→Resistant or refractory→
03
Public criteria

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.

Requirements people may need to meetInclusion criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Minimum life expectancy of at least 12 weeks.
  • Laboratory values meeting the criteria specified in the protocol.
  • Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) with documented disease progression after at least 2 prior systemic regimens, including at least one platinum-based regimen.
  • Delta-Like Protein 3 (DLL3)-expressing SCLC based on central immunohistochemistry (IHC) assessment of banked or otherwise representative tumor tissue.
  • Measurable disease as described per protocol.
  • In participants with a history of central nervous system (CNS) metastases, 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.
Reasons someone may not be able to joinExclusion criteria
  • 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 Class III - IV within 6 months prior to first dose of study drug.
  • Recent or on-going serious infection.
  • History of other invasive malignancy that has not been in remission for at least 3 years.
  • History of exposure to a pyrrolobenzodiazepine (PBD)-based drug or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation.
  • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells.
  • Documented history of capillary leak syndrome.
  • Grade 2 or higher pleural or pericardial effusion within 4 weeks of investigational drug start, or earlier history of recurrent Grade 2 or higher effusions with ongoing requirements for pericardiocentesis or thoracentesis.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Ironwood Cancer & Res Ctr /ID# 171335Chandler, Arizona
  • Mayo Clinic - Scottsdale /ID# 171359Scottsdale, Arizona
  • VA Central California Health C /ID# 170951Fresno, California
  • Loma Linda University Medical /ID# 171377Loma Linda, California
  • UC Irvine Health /ID# 171343Orange, California
  • Kaiser Permanente - Roseville /ID# 200779Roseville, California
  • Kaiser Permanente-Santa Clara /ID# 203024Santa Clara, California
  • Kaiser Permanente Medical Ctr-Vallejo /ID# 169758Vallejo, California
  • Kaiser Permanente- Walnut Creek /ID# 201305Walnut Creek, California
  • Univ of Colorado Cancer Center /ID# 200810Aurora, Colorado
  • Boca Raton Regional Hospital /ID# 200168Boca Raton, Florida
  • UMHC/Sylvester Comprehensive /ID# 171462Deerfield Beach, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 26, 2018. Always confirm current availability with the study team.

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