Crizotinib for Lung Cancer

(Drugs-SNPs Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Han Xu, MD/PhD/FAPCR

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

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

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

Explore the relationship between drug target ALK gene single nucleotide polymorphisms and XALKORI - Crizotinib therapeutic-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets' genes. Explore the relationship between drug target CYP4503A gene single nucleotide polymorphisms and XALKORI - Crizotinib side-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.

Research Team

Han Xu, MD/PhD/FAPCR

Principal Investigator

Medicine Invention Design, Inc. - IORG0007849

Han Xu, MD/PhD/FAPCR

Principal Investigator

Medicine Invention Design, Inc. - IORG0007849

Han Xu, MD/PhD/FAPCR

Principal Investigator

Medicine Invention Design, Inc. - IORG0007849

Eligibility Criteria

This trial is for adults over 22 with non-small cell lung cancer (NSCLC) confirmed by a lung tissue biopsy. Participants must have measurable disease, good performance status, and proper organ function. They cannot be pregnant or breastfeeding, have serious bleeding tendencies or allergies to drugs, be undergoing other cancer treatments that can't stop, or have multiple cancers.

Inclusion Criteria

I am generally healthy and active.

My lung cancer was confirmed through a tissue biopsy.

Random and double blind

Exclusion Criteria

I have had a surgery to remove one of my lungs.

I have a condition that causes serious bleeding.

The prohibition of drug products

Treatment Details

Interventions

• Crizotinib (Tyrosine Kinase Inhibitor)

Trial Overview The study investigates how genetic differences in the ALK gene and CYP4503A gene affect the effectiveness and side effects of Crizotinib in NSCLC patients. It involves precise gene sequencing and compares standard Crizotinib treatment against a study variant under double-blind conditions.

Participant Groups

Group I: Crizotinib - Usual Experimental Treatment 1 Intervention

* XALKORI - Crizotinib * Chemotherapy * XALKORI - crizotinib capsule * XALKORI 250 mg taken orally twice daily * Usual Approach Group (high dose)

Group II: Crizotinib - Study Experimental Treatment 1 Intervention

* XALKORI - Crizotinib * Chemotherapy * XALKORI - crizotinib capsule * XALKORI 200 mg taken orally twice daily * Usual Approach Group (low dose)

Crizotinib is already approved in Japan, Canada for the following indications:

Approved in Japan as Xalkori for:

• Non-small cell lung cancer (NSCLC) with ALK rearrangements

Approved in Canada as Xalkori for:

• Non-small cell lung cancer (NSCLC) with ALK rearrangements

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

6

Recruited

2,400+