A Phase 1b/2, Open-Label, Randomized Study of Daratumumab Administered in Combination With Atezolizumab Compared With Atezolizumab Alone in Subjects With Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer

Trial Profile

A Phase 1b/2, Open-Label, Randomized Study of Daratumumab Administered in Combination With Atezolizumab Compared With Atezolizumab Alone in Subjects With Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer

Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 01 Aug 2018

At a glance

  • Drugs Daratumumab (Primary) ; Atezolizumab
  • Indications Non-small cell lung cancer
  • Focus Therapeutic Use
  • Acronyms CALLISTO; DARZALEX
  • Sponsors Janssen Research & Development
  • Most Recent Events

    • 26 May 2018 Status changed from recruiting to discontinued, as reported in the Genmab media release.
    • 26 May 2018 According to a Genmab media release, the company decided to terminate this trial as the Data Monitoring Committee (DMC) determined that there was no observed benefit within the combination treatment arm, daratumumab plus atezolizumab, over atezolizumab monotherapy, and recommended termination of the study. The DMC also noted a numerical increase in mortality-related events in the combination arm, in a recent planned analysis.
    • 24 May 2018 Planned End Date changed from 16 Oct 2020 to 14 Oct 2019.
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