ALK-Positive Non-Small Cell Lung Cancer (NSCLC)Phase 2/3Drugs-SNPsNCT05987956

Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms

A Phase 2/3 study testing ALECENSA - alectinib hydrochloride capsule in people with ALK-Positive Non-Small Cell Lung Cancer (NSCLC), run by Medicine Invention Design, Inc at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 24 to 64 years
Conditions the study is for: ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
What is being tested?: ALECENSA - alectinib hydrochloride capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 600 participants
Where: 2 sitesUnited States
Study dates: 18 Mar 2026to 28 Dec 2026
Phase: Phase 2/3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 24 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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. Sequential Assignment
4. Measurable disease

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5. Adequate organ functions
6. Adequate performance status
7. Age 24-64 years old
8. Sign an informed consent form
9. Receive blood-drawing

Who cannot join

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

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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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Omnicure Clinical Research
Doral, Florida, 33172
Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
Rockville, Maryland, 20853

Other trials in United States

About this study

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

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.

Read the detailed description

The usual approach group, diagnosed metastatic ALK-positive NSCLC, 300 Sequential Assignment group separated NSCLC patients currently used the Chemotherapy on ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily, it will try to look for the relationship between the Alectinib therapeutic efficacy and the ALK SNP Genotyping, and the relationship between the Alectinib therapeutic safety and the CYP4503A SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.

The study approach group, diagnosed metastatic ALK-positive NSCLC, 300 Sequential Assignment group separated NSCLC patients currently used the Chemotherapy on ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily, it will try to look for the relationship between the Alectinib therapeutic efficacy and the ALK SNP Genotyping, and the relationship between the Alectinib therapeutic safety and the CYP4503A4 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.

Detect drug target whole gene precision sequence of everyone patient for all 600 recruited Sequential Assignment NSCLC patients.
Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited Sequential Assignment NSCLC patients.
Calculate drug target gene SNPs in all 600 recruited Sequential Assignment NSCLC patients.
Correlate everyone patient drug target gene SNP to everyone patient drug efficacy.
Correlate everyone patient drug target gene SNP to everyone patient drug safety.
Mutually compare the usual approach group SNPs (300 Sequential Assignment group separated NSCLC patients) with the study approach group SNPs (300 Sequential Assignment group separated NSCLC patients).
Confirm the relationship between drug target gene SNPs and drug efficacy.
Confirm the relationship between drug target gene SNPs and drug safety.

Conditions: ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
Being tested: ALECENSA - alectinib hydrochloride capsule
Keywords: ALK, EGFR, NSCLC, SNP, Pharmacogenomics, Gene, Genetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ALECENSA - alectinib hydrochloride capsuleDrug
Also called ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily
- Usual Alectinib Chemotherapy (NDC...01)
- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily
- Study Alectinib Chemotherapy (NDC...86)
- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily

Study groups in NCT05987956
Study group	Role	What they receive
ALECENSA - alectinib hydrochloride capsule	Experimental	* Usual Alectinib Chemotherapy (NDC...01) * ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily * Usual Approach Group (NDC...01) (Patient 1-300) * Study Alectinib Chemotherapy (NDC...86) * ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily * Study Approach Group (NDC...86) (Patient 301-600) Receives: Drug: ALECENSA - alectinib hydrochloride capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated
- Select 300 Sequential Assignment group separated ALK-Positive Metastatic NSCLC patients currently using the Chemotherapy NDC...01 ALECENSA - alectinib 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, to be the usual approach group.
- Select 300 Sequential Assignment group separated ALK-Positive Metastatic NSCLC patients currently using the Chemotherapy NDC...86 ALECENSA - alectinib 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, to be the study approach group.
- Measure above every NSCLC patient-specific Alectinib drug target (ALK) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.
- Report every NSCLC patient-specific ALK SNP genotype in whole genome DNA sequence.
Measured: Up to 12 weeks
Measure and Report Alectinib Drug Targets' SNP Genotypes which are risk-associated
- Select 300 Sequential Assignment group separated ALK-Positive Metastatic NSCLC patients currently using the Chemotherapy NDC...01 ALECENSA - alectinib 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, to be the usual approach group.
- Select 300 Sequential Assignment group separated ALK-Positive Metastatic NSCLC patients currently using the Chemotherapy NDC...86 ALECENSA - alectinib 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, to be the study approach group.
- Measure above every NSCLC patient-specific Alectinib drug target (CYP3A4) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.
- Report every NSCLC patient-specific CYP3A4 SNP genotype in whole genome DNA sequence.
Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Mar 202628 Dec 2026

First posted14 Aug 2023
Study start18 Mar 2026
Primary completion18 Nov 2026 (estimated)
Study completion28 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ALK-Positive Non-Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Sequential
Model description: * The usual approach group (NDC...01) (Group 1) (Patient 1-300) * The study approach group (NDC...86) (Group 2) (Patient 301-600)
Masking: None (open label)
Enrolment: 600 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05987956
Sponsor's protocol ID: IND 168453 SNP
Other IDs: FWA00015357, NPI - 1831468511, NPI - 1023387701, IRB00009424, IORG0007849, IND 168453
Acronym: Drugs-SNPs
Status last verified: Oct 2026
First submitted: 29 Jul 2023
Last updated: 8 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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