Ensayos clínicos

Inclusion Criteria

• Unresectable locally advanced or metastatic NSCLC with EGFR activating mutation (excluding exon 20 insertion) and presence of the T790M mutation
• Prior treatment with an approved or experimental EGFR-directed therapy 
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1 
• Adequate hematological and biological function
• Written informed consent on an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved ICF before any study-specific evaluation

Exclusion Criteria

• Eligibility for other enrolling clinical trials of rociletinib
• Leptomeningeal carcinomatosis or other untreated or symptomatic CNS metastases
  • Asymptomatic CNS metastases allowed if clinically stable without requirement for steroid dose increase for at least 4 weeks
• History of prior interstitial lung disease
• Concurrent use of QT-prolonging medication
• Cardiac abnormalities
  • Clinically significant abnormal 12-lead ECG
  • QT interval corrected using Fridericia's method (QTcF) > 450 ms 
  • Inability to measure QT interval on ECG 
  • Personal or family history of long QT syndrome 
  • Implantable pacemaker or implantable cardioverter defibrillator 
  • Resting bradycardia < 55 beats/min 
• Presence of serious or unstable concomitant systemic disorder incompatible with the clinical study 
  • Substance abuse
  • Uncontrolled intercurrent illness including active infection
  • Arterial thrombosis
  • Symptomatic pulmonary embolism
  • Other active malignancy associated with life expectancy of less than 1 year
• Pregnant or breastfeeding females 
• Male or female patients who refuse to use adequate contraception during the study and for 12 weeks after the last dose of rociletinib 
• Any contraindication, allergy, or hypersensitivity to rociletinib or excipients