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A Study Of Crizotinib Versus Chemotherapy In Previously Untreated ALK Positive East Asian Non-Small Cell Lung Cancer Patients

Last updated on March 14, 2019

Study Location
The First Affiliated Hospital of Anhui Medical University, Department of Medical Oncology
Hefei, Anhui, 230002 China
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
NSCLC (Non-small Cell Lung Cancer)
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 for at least 2 weeks and

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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]

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 CYP3A inducers/inhibitors Concurrent use
of drugs that are CYP3A substrates with narrow therapeutic indices.

- Known HIV infection

- History of extensive disseminated/bilateral or known presence of Grade 3 or 4
interstitial fibrosis or interstitial lung disease, including a history of
pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung
disease, obliterative bronchiolitis, and pulmonary fibrosis, but not history of prior
radiation pneumonitis.

- Other severe acute or chronic medical conditions (including severe gastrointestinal
conditions such as diarrhea or ulcer) or psychiatric conditions, or end-stage renal
disease on hemodialysis, 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.

Active, not recruiting
A Study Of Crizotinib Versus Chemotherapy In Previously Untreated ALK Positive East Asian Non-Small Cell Lung Cancer Patients


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