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This study examines the relationship between Alectinib treatment and single nucleotide polymorphisms (SNPs; individual genetic differences) in patients with ALK-positive metastatic non-small cell lung cancer. It enrolls patients aged 24 to 64 who have been taking Alectinib twice daily for at least 90 days. The study is in Phase 2/Phase 3 and is currently active but not recruiting new participants (active, not recruiting).
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
* Select 600 patients with Metastatic ALK-Positive Non-Small Cell Lung Cancer (NSCLC) as follows: * Took ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily more than 90 days * Had no further NSCLC metastatic or growth in more than previous 90 days * Dosage Duration at least 90 days * The usual approach group - Recruit 300 double blind random group separated NSCLC patients currently used the Chemotherapy NDC...01 on ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily, film coated diagnosed metastatic ALK-positive NSCLC, like as the usual approach group. * The study approach group - Recruit 300 double blind random group separated NSCLC patients currently used the Chemotherapy NDC...86 on ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily, film coated diagnosed metastatic ALK-positive NSCLC, like as the study approach group. Inclusion Criteria: * 1\. Metastatic ALK-Positive Non-Small Cell Lung Cancer (NSCLC) as follows: * Took ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily more than 90 days * Had no further NSCLC metastatic or growth in more than previous 90 days * 2\. Suitable for enough blood-drawing * 3\. Random and double blind * 4\. Measurable disease * 5\. Adequate organ functions * 6\. Adequate performance status * 7\. Age 24-64 years old * 8\. Sign an informed consent form * 9\. Receive blood-drawing Exclusion Criteria: * 1\. Pneumonectomy * 2\. Treatment with other anti-cancer therapies and cannot be stopped currently * 3\. Pregnancy * 4\. Breast-feeding * 5\. The patients with other serious intercurrent illness or infectious diseases * 6\. Have more than one different kind of cancer at the same time * 7\. Serious Allergy to Drugs * 8\. Serious Bleed Tendency * 9\. Serious Risks or Serious Adverse Events of the drug product * 10\. The prohibition of drug products * 11\. Have no therapeutic effects * 12\. Follow up to the most current label