• GEOQ
Titre A Randomized Phase 3 Study of the Combination of Pembrolizumab Plus Epacadostat Alone or With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer
Protocole ID MK-3475-715/KEYNOTE-715-05
ClinicalTrials.gov ID NCT03322566
Site Anatomique Poumon non à petites cellules
Phase Phase III
Stade Métastatique
Type étude Traitement
Médicament Epacadostat, Pembrolizumab, Chimio
Institution    CENTRE HOSPITALIER DE ST. MARY
      3830 av. Lacombe, Montréal, QC, H3T 1M5
CIUSSS DE L'OUEST-DE-L'ILE-DE-MONTREAL
Ville Montreal
Investigateur principal Dr Adrian Langleben
Coordonnateur Dora Bartulovic
Statut Actif en recrutement
Date d'activation
Critètes d'éligibilité
  • Histologically or cytologically confirmed diagnosis of stage IV NSCLC without epidermal growth factor receptor (EGFR)-sensitizing mutation, ROS1 and/or anaplastic lymphoma kinase (ALK) translocation
  • Measurable disease based on RECIST 1.1
  • Life expectancy of at least 3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function per protocol-defined criteria.
  • Provide tumor tissue sample.
Critètes d'exclusion
  • Known untreated central nervous system metastases and/or carcinomatous meningitis
  • History of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
  • Symptomatic ascites or pleural effusion.
  • Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
  • Active autoimmune disease that has required systemic treatment in past 2 years.
  • Has had an allogeneic tissue/solid organ transplant.
  • Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority.
  • Has known history of or is positive for active Hepatitis B (HBsAg reactive) or has active Hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
  • History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful.
  • Use of protocol-defined prior/concomitant therapy.