Denosumab in Combination With Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer

Official Title

A Randomized, Double-blind, Multi-centre Phase 2 Trial of Denosumab in Combination With Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer

Summary:

This randomized phase 2 trial is studying the effect of adding denosumab to standard chemotherapy in the treatment of advanced lung cancer.

Trial Description

Primary Outcome:

  • Relative benefit on overall survival (OS)
Secondary Outcome:
  • Tumour Tissue RANK expression in correlation with overall survival
  • Tumour tissue RANK expression in correlation with objective response rate (CR+PR) based on modified RECIST 1.1
  • Tumour tissue RANKL expression in correlation with overall survival
  • Tumour tissue RANKL expression in correlation with objective response (CR + PR) based on modified RECIST 1.1
  • Objective response, clinical benefit rate & progression-free survival based on modified RECIST 1.1
  • Serum denosumab trough levels
  • Treatment-emergent adverse events
This is a global phase 2 randomized double-blind placebo-controlled study in subjects with Stage IV untreated NSCLC with or without bone metastasis. Eligible subjects are to receive 4 to 6 cycles of a standard of care platinum-doublet chemotherapy regimen. Approximately 216 subjects will be randomized in a 2:1 ratio to receive denosumab or matching placebo with the first investigational product dose coinciding with subject's first cycle of chemotherapy and continuing until the primary analysis, unacceptable toxicity, withdrawal of consent, death, or lost to follow-up. Subjects will be offered open label denosumab if study results show a positive benefit:risk profile, or be followed long-term, for up to 2 years. All subjects are to receive daily dietary supplements of at least 500 mg of calcium and 400 IU of vitamin D.

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