Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC
Condition: Non Small Cell Lung Cancer; ROS1 Proto Oncogene; Crizotinib
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Crizotinib
Intervention MeSH terms: Crizotinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non small cell lung cancer; NSCLC; ROS1; ROS1 positive; ROS1 proto oncogene; c ros tyrosine kinases; ROS1 positive NSCLC; ROS1 lung cancer; ALK negative; Lung Carcinoma; Neoplasm; Crizotinib; Xalkori; Previously treated or untreated; North East Asian

Summary:

      To assess treatment effectiveness and safety of oral crizotinib administered to East Asian
      patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive
      for a ROS1 positive gene mutation (translocation or inversion) and confirmed negative for an
      ALK mutation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or
             metastatic

          -  treatment-naïve or have received no more than 3 systemic treatment regimen(s)

          -  Positive for translocation or inversion events involving the ROS1 gene

          -  Negative for translocation or inversion events involving the ALK gene

          -  Patients with brain metastases are eligible if asymptomatic, or if treated, must be
             neurologically stable for at least 2 weeks and are not taking any contraindicated
             medications

          -  Any prior treatment (chemotherapy, radiation [except for palliative], or surgery) must
             have been completed at least 2 weeks prior to initiation of study medication

          -  At least 1 measurable tumor lesion as per RECIST v1.1

          -  Female or male, 18 years of age or older

          -  ECOG performance status 0 to 1

          -  Adequate organ function

          -  Signed and dated informed consent

          -  Willingness and ability to comply with scheduled visits, treatment plans, laboratory
             tests, and other study procedures, including completion of the PRO measures

          -  Agree to use effective contraception during the study period and for at least 90 days
             after completion of the study treatment

        Exclusion Criteria:

          -  Current treatment on another therapeutic clinical trial

          -  Prior therapy specifically directed against ALK or ROS1 fusion genes

          -  Spinal cord compression unless treated with the patient attaining good pain control
             and stable or recovered neurologic function, carcinomatous meningitis, or
             leptomeningeal disease

          -  known interstitial fibrosis or interstitial lung disease

          -  myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
             graft, congestive heart failure, or cerebrovascular accident including transient
             ischemic attack within 3 months prior to start of study treatment

          -  Ongoing cardiac dysrhythmias of NCI CTCAE v4.03 Grade >/=2, uncontrolled atrial
             fibrillation of any grade, or QTc >470 msec

          -  Pregnant or breast feeding

          -  Use of drugs or foods that are known potent CYP3A4 inhibitors or inducers

          -  Use of other anti-cancer drugs including traditional Chinese medicine on the SFDA list

          -  Evidence of active malignancy within last 3 years