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.
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
- Are there results?
- Not yet: the study is under way
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
Show all 11Show fewer
- 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
Show all 12Show fewer
- 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
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 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.
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Medicine Invention Design, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UnitedHealthcare, Omnicure Clinical Research, Responsible Party: Individual Sponsor: Han Xu, M.D., Ph.D., FAPCR, Medical Director, IRB Chair
- Responsible party
- Sponsor
- Investigators
- Han Xu, MD/PhD/FAPCR, Principal investigator, Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701Han Xu, MD/PhD/FAPCR, Study director, Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701Han Xu, MD/PhD/FAPCR, Study chair, Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701Anneyd Avalos, M.D., Principal investigator, Omnicure Clinical Research - Site 1Felipe Gascon-Rondon, M.D., Principal investigator, Omnicure Clinical Research - Site 2Jeffrey Levy, M.D., Principal investigator, Omnicure Clinical Research - Site 3Ellie Soheili, M.D., Principal investigator, Omnicure Clinical Research - Site 4Marc E. Csete, M.D., Principal investigator, Omnicure Clinical Research - Site 5
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Relationship Between Single Nucleotide Polymorphisms and Alectinib Response and Toxicity in Patients With Non-Small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT05987956
- Acronym / sponsor ID
- Drugs-SNPs / IND 168453 SNP
- Keywords
- ALK, EGFR, NSCLC, SNP, Pharmacogenomics, Gene, Genetics
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Medicine Invention Design, IncIndustry (pharma, biotech, devices)
- Collaborators
- UnitedHealthcare, Omnicure Clinical Research, Responsible Party: Individual Sponsor: Han Xu, M.D., Ph.D., FAPCR, Medical Director, IRB Chair
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 18 Nov 2026 (estimated)
- Study completion
- 28 Dec 2026 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- * The usual approach group (NDC...01) (Group 1) (Patient 1-300) * The study approach group (NDC...86) (Group 2) (Patient 301-600)
| Arm | Type | Receives |
|---|---|---|
| ALECENSA - alectinib hydrochloride capsule | Experimental | Drug: ALECENSA - alectinib hydrochloride capsule* 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) |
Who may qualify
- Ages
- 24 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALECENSA - alectinib hydrochloride capsuleAlso: 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 | Drug | ALECENSA - alectinib hydrochloride capsule |
Primary outcome
Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated
Time frame: Up to 12 weeks
* 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.
Measure and Report Alectinib Drug Targets' SNP Genotypes which are risk-associated
Time frame: Up to 12 weeks
* 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- FWA \< 00015357 \> \< Medicine Invention Design Incorporation \>Link provided by the sponsor.
- IRB \< 00009424 \> \< Medicine Invention Design Incorporation \>Link provided by the sponsor.
- IORG \< 0007849 \> \< Medicine Invention Design Incorporation \>Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Han Xu, MD/PhD/FAPCR principal investigator
Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
Han Xu, MD/PhD/FAPCR study director
Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
Han Xu, MD/PhD/FAPCR study chair
Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated (time frame: Up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.