Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms

Running, not enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: ALK-Positive Non-Small Cell Lung Cancer (NSCLC)

In brief

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 precisely sequencing drug targets' genes. Explore the relationship between drug target CYP4503A4 gene single nucleotide polymorphisms and ALECENSA - Alectinib side-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.

Key facts

Study ID

NCT05987956

Run by

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

People needed

600

Starts

2026-03-18

Expected to finish

2026-12-28

Last updated by the study team

2026-07-01

Who can join

Age: 24 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Omnicure Clinical Research — Doral, Florida, United States
• Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701 — Rockville, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.