Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT05987956
Eligibility Criteria:
* Select 600 Non-Small Cell Lung Cancer Patients who are suitable for blood-drawing.
* 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 after biopsy diagnosis, 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 after biopsy diagnosis, like as the study approach group.
Inclusion Criteria:
* 1\. Clinical diagnosis of Non-Small Cell Lung Cancer (NSCLC)
* 2\. Clinical biopsy diagnosis of NSCLC
* 3\. Suitable for enough blood-drawing
* 4\. Random and double blind
* 5\. Measurable disease
* 6\. Adequate organ functions
* 7\. Adequate performance status
* 8\. Age 22 years old and over
* 9\. Sign an informed consent form
* 10\. 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
75 Years
Study:
NCT05987956
Study Brief:
Protocol Section:
NCT05987956