A Phase II, Open Label, Multiple Arm Study of AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advanced Non-small Cell Lung Cancer
Condition: Adenocarcinoma Lung Cancer; Squamous Cell Lung Carcinoma
MeSH terms: Lung Neoplasms; Adenocarcinoma; Adenocarcinoma of Lung
Intervention: BYL719; INC280; LDK378; MEK162
Intervention description: BYL719 was dosed as 350 mg once daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to take BYL719 exactly as prescribed.; INC280 was dosed as 600 mg (tablet) or 400mg(Capsule) twice daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to takeINC280 exactly as prescribed.; LDK378 was dosed as 750 mg once daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to take LDK378 exactly as prescribed.; MEK162 was dosed as 45 mg twice daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to take MEK162 exactly as prescribed.
Intervention MeSH terms: Ceritinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma lung cancer,; squamous cell lung carcinoma,; NSCLC

Summary:

      The purpose of this study was to evaluate the anti-tumor activity of single agent BYL719,
      INC280, LDK378 and MEK162 in advanced NSCLC patients carrying specific molecular alterations.

      There is a great unmet medical need in NSCLC patients with advanced or metastatic disease.
      Novel approaches using targeted therapeutic agents for these patient populations with
      molecular characterization could potentially identify subsets of advanced NSCLC patients who
      would benefit from targeted kinase inhibition. Study treatments, BYL719, INC280, LDK378 and
      MEK162, which target PIK3CA, c-MET, ALK/ROS1 and MEK respectively, have shown promising data
      in either preclinical or clinical lung cancer settings.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced (stage IIIB or stage IV) NSCLC

          -  Must have specific molecular alterations

        Exclusion Criteria:

          -  Symptomatic central nervous system (CNS) metastases which are neurologically unstable
             or requiring increasing doses of steroids within the 4 weeks prior to study entry to
             control their CNS disease

          -  Radiation therapy within ≤ 4 weeks prior to study entry, with the exception of limited
             field palliative radiotherapy for bone pain relief.

          -  Any other malignancies within the last 5 years before study entry

          -  Major surgery ≤ 2 weeks prior to study entry or who have not recovered from side
             effects of such therapy