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ACTIVE NOT RECRUITING
NCT05987956
PHASE2/PHASE3

Bioequivalence ANDA SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms

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

View on ClinicalTrials.gov

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 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.

Official title: Explore the Relationship Between Single Nucleotide Polymorphisms and Alectinib Response and Toxicity in Patients With Non-Small Cell Lung Cancer.

Key Details

Gender

All

Age Range

22 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2026-03-18

Completion Date

2026-12-28

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

DRUG

Alectinib - Usual

Usual Alectinib Chemotherapy (NDC...01) \- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily

DRUG

Alectinib - Study

Study Alectinib Chemotherapy (NDC...86) \- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily

Locations (1)

Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

Rockville, Maryland, United States