Non Squamous Lung Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Crizotinib (PF-02341066)
INN of investigational material : Crizotinib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration fo
Sponsors
Pfizer Japan Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Histologically or cytologically proven diagnosis of locally advanced not suitable for local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung * Positive for translocation or inversion events involving the ALK gene locus * No prior systemic treatment for locally advanced or metastatic disease; Patients with brain metastases only if treated and neurologically stable with no ongoing requirement for corticosteroids * Evidence of a personally signed and dated informed consent document and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures including completion of patient reported outcome [PRO] measures.
Exclusion criteria
Exclusion criteria: * Current treatment on another therapeutic clinical trial. * Prior therapy directly targeting ALK * Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. - - Appropriate treatment with anticoagulants is permitted * Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial fibrillation of any grade, or QTc interval >470 msec * Pregnancy or breastfeeding * Use of drugs or foods that are known potent CYP3A4 inducers/inhibitors * Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices * Known HIV infection * Known interstitial fibrosis or interstitial lung disease * Other severe acute or chronic medical (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * PFS based on RECIST version 1.1 (documented by independent radiology laboratory) As with above | — |
Secondary
| Measure | Time frame |
|---|---|
| * ORR (documented by independent radiology laboratory), OS at 6 months and 1 year, OS and DR * Type, incidence, severity, seriousness and relationship to study medications of adverse events (AE) and any laboratory abnormalities * Plasma concentrations of crizotinib (including its active moieties, if appropriate) * Proportion of patients with each of the ALK fusion variants of the EML4-ALK fusion * Time to deterioration in pain, dyspnea, or cough patient reported disease symptoms * HRQoL, disease/treatment-related symptoms, and general health status * HCRU with respect to hospitalizations and concomitant medication use for select adverse events (eg, hematologic events) (HCRU: health care resource utilization) As with above | — |
Outcome results
None listed