Status:
NOT_YET_RECRUITING
Pharmacogenomics IND EXEMPT SNP Clinical Study - Alectinib and Single Nucleotide Polymorphisms
Lead Sponsor:
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Collaborating Sponsors:
UnitedHealthcare
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
22-75 years
Phase:
PHASE2
PHASE3
Brief Summary
Explore the relationship between drug target ALK gene single nucleotide polymorphisms and ALECENSA - Alectinib therapeutic-effects in patients with non-small cell lung cancer, based on Oxford precisel...
Detailed Description
The usual approach group, after biopsy diagnosis, 300 double blind random group separated NSCLC patients currently used the Chemotherapy on ALECENSA - alectinib hydrochloride capsule 600 mg orally twi...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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
Key Trial Info
Start Date :
November 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 28 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT05987956
Start Date
November 8 2025
End Date
December 28 2026
Last Update
June 6 2025
Active Locations (1)
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1
Medicine Invention Design, Inc. - IORG0007849
Rockville, Maryland, United States, 20853