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

Official Title

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

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).

Trial Description

Primary Outcome:

  • Number of Participants with a High Grade (>= Grade 3) Protocol Specified TEAE
Secondary Outcome:
  • Change in Participant Reported Outcome EORTC QLQC15-PAL
  • Progression Free Survival (PFS)
  • Overall Survival (OS)
  • Objective response rate (ORR)
  • Change in EORTC QLQ-LC-13
  • Duration of Objective Response (DOR)
  • Clinical Benefit Rate (CBR)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society