Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003)

Titre officiel

A Phase 3, Multicentre, Randomized, Double-Blind Study of MK-7684 With Pembrolizumab as a Coformulation (MK-7684A) Versus Pembrolizumab Monotherapy as First Line Treatment for Participants With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer

Sommaire:

Selon les principales hypothèses, le produit coformulé composé du pembrolizumab et du vibostolimab est supérieur au pembrolizumab seul en ce qui concerne la survie sans progression (PFS) selon les critères RECIST (Response Evaluation Criteria in Solid Tumours), version 1.1, évalués par un examen central indépendant à l’insu (ECII), et en ce qui concerne la survie globale (OS), chez les participants atteints d’un cancer du poumon non à petites cellules.

Description de l'essai

Primary Outcome:

  • Progression-Free Survival (PFS)
  • Overall Survival (OS)
Secondary Outcome:
  • Objective Response Rate (ORR)
  • Duration of Response (DOR)
  • Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
  • Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
  • Change from Baseline in Dyspnea Score (Item 8) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
  • Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13)
  • Change from Baseline in Chest Pain Score (Item 40) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13)
  • Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
  • TTD in Physical Functioning (Items 1-5) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
  • TTD in Dyspnea Score (Item 8) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
  • TTD in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13)
  • TTD in Chest Pain Score (Item 40) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13)
  • Number of Participants Who Experienced One or More Adverse Events (AEs)
  • Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)

Voir cet essai sur ClinicalTrials.gov

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