NCT03334487

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

Open-Label, Single Arm, Phase 3b Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory DLL3 Expressing Small Cell Lung Cancer

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Dexamethasone	Oral
DRUG	Rovalpituzumab tesirine	Intravenous

Timeline

• Start date: 2018-03-15
• Primary completion: 2018-12-20
• Completion: 2018-12-20
• First posted: 2017-11-07
• Last updated: 2018-12-26

Locations

60 sites across 7 countries: United States, Australia, Brazil, Canada, Germany, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study