Study of Sacituzumab Govitecan-hziy (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-programmed Death Protein 1 (PD-1)/Programmed Death Ligand 1 (PD-L1) Immunotherapy

Official Title

Open-Label, Global, Multicentre, Randomized, Phase 3 Study of Sacituzumab Govitecan Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy

Summary:

The primary objective of this study is to compare overall survival (OS) of sacituzumab govitecan-hziy (SG) versus docetaxel in participants with advanced or metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy and anti-programmed death protein 1 (PD-1)/ programmed death ligand 1 (PD-L1) immunotherapy received either in combination or sequentially. Participants will be randomly assigned in a 1:1 ratio to receive either SG or docetaxel.

Trial Description

Primary Outcome:

  • Overall Survival (OS)
Secondary Outcome:
  • Progression-free Survival (PFS) Assessed by Investigator per Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1
  • Objective Response Rate (ORR) Assessed by Investigator per RECIST Version 1.1
  • Duration of Response (DOR) Assessed by Investigator per RECIST Version 1.1
  • Disease Control Rate (DCR) Assessed by Investigator per RECIST Version 1.1
  • Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
  • Percentage of Participants Experiencing Laboratory abnormalities
  • Mean Change From Baseline in Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) Total Score
  • Mean Change From Baseline in Shortness of Breath as Measured by NSCLC-SAQ

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