Study of DS-1062A Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-LUNG01)

Titre officiel

Phase 3 Randomized Study of DS-1062A Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-LUNG01)

Sommaire:

This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations.

Description de l'essai

Primary Outcome:

  • Progression-free Survival (PFS) As Assessed by Investigator Per RECIST v1.1 Following DS-1062a Versus Docetaxel
  • Overall Survival (OS) Following DS-1062a Versus Docetaxel
Secondary Outcome:
  • Objective Response Rate (ORR) As Assessed by Investigator Per RECIST v1.1 Following DS-1062a Versus Docetaxel
  • Duration of Response (DOR) As Assessed by Investigator Per RECIST v1.1 Following DS-1062a Versus Docetaxel
  • Time to Response (TTR) As Assessed by Investigator Per RECIST v1.1 Following DS-1062a Versus Docetaxel
  • Disease Control Rate (DCR) As Assessed by Investigator Per RECIST v1.1 Following DS-1062a Versus Docetaxel
  • European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ) and EORTC Quality of Life Questionnaire (QLQ) for Lung Cancer Trials Scores (Except Questions 36 and 37) Following DS-1062a Versus Docetaxel
  • Percentage of Participants Who Reported Treatment-emergent Adverse Events Following DS-1062a Versus Docetaxel
  • Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of DS-1062a, Total Anti-Trophoblast cell surface protein 2 (Anti-TROP2) Antibody, and Active Metabolite MAAA-1181a
  • Pharmacokinetic Parameter Time to Maximum Plasma Concentration (Tmax) of DS-1062a, Total Anti-TROP2 Antibody, and Active Metabolite MAAA-1181a
  • Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC) of DS-1062a, Total Anti-TROP2 Antibody, and Active Metabolite MAAA-1181a
  • Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Proportion of Participants Who Have Treatment-emergent ADA
This study will evaluate DS-1062a 6.0 mg/kg vs docetaxel 75 mg/m^2 in participants with advanced or metastatic NSCLC without actionable genomic alterations and who have been previously treated with platinum-based chemotherapy and α-PD-1/α-PD-L1 monoclonal antibody, either in combination or sequentially. The study will be divided into 3 periods: Screening Period, Treatment Period, and Follow-up Period.

Voir cet essai sur ClinicalTrials.gov

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