Alectinib Pharmacogenomics 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 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial investigates how genetic differences in patients with non-small cell lung cancer affect their response to ALECENSA treatment. By studying these genetic variations, researchers aim to improve the effectiveness and safety of the medication.

Eligibility Criteria

Adults over 22 with non-small cell lung cancer (NSCLC) who can undergo a lung tissue biopsy and have not used other anti-cancer therapies. They must be in good health otherwise, able to sign consent, and not pregnant or breastfeeding. Those with serious allergies, bleeding tendencies, multiple cancers, or severe illnesses cannot join.

Inclusion Criteria

My organs are working well.

I am physically active and can care for myself.

Sign an informed consent form

Exclusion Criteria

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

Treatment with other anti-cancer therapies and cannot be stopped currently

Pregnancy

Participant Groups

The study is looking at how genetic differences affect the way Alectinib works for NSCLC treatment. It involves precise gene sequencing to understand this relationship better and will compare usual Alectinib use against a study-specific approach.

Group I: Alectinib - Usual Experimental Treatment 1 Intervention

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

Group II: Alectinib - Study Experimental Treatment 1 Intervention

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

Alectinib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Alecensa for:

• Metastatic ALK-positive non-small cell lung cancer (NSCLC)
• Adjuvant treatment following tumor resection in patients with ALK-positive NSCLC

🇪🇺 Approved in European Union as Alecensa for:

• Metastatic ALK-positive non-small cell lung cancer (NSCLC)
• Adjuvant treatment following tumor resection in patients with ALK-positive NSCLC

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Medicine Invention Design, Inc. - IORG0007849 Rockville, MD

Who Is Running the Clinical Trial?

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

UnitedHealthcare Collaborator

References