Small Cell Lung CancerPhase 2/3Drugs-SNPsNCT01064466

Pharmacogenomics ANDA SNP Clinical Study - Etoposide and Single Nucleotide Polymorphisms

A Phase 2/3 study testing ETOPOSIDE - Usual and ETOPOSIDE - Study in people with Small Cell Lung Cancer, run by Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair at 1 site 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 topoisomerase II gene single nucleotide polymorphisms and Etoposide (VP-16) therapeutic-effects in patients with 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: Small Cell Lung Cancer
What is being tested?: ETOPOSIDE - Usual and ETOPOSIDE - Study
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 600 participants
Where: 1 siteUnited States
Study dates: 16 Jul 2025to 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

Select 600 Small Cell Lung Cancer Patients who are suitable for lung tissue biopsy
Dosage Duration at least 45 days
The usual approach group - Recruit 300 double blind random group separated SCLC patients currently used the Chemotherapy on Etoposide Capsule after lung tissue biopsy, like as the usual approach group.
The study approach group - Recruit 300 double blind random group separated SCLC patients currently used the Chemotherapy on China Import Etoposide Capsule after lung tissue biopsy, like as the study approach group.

The inclusion criteria:

1. Clinical diagnosis of Small Cell Lung Cancer (SCLC)
2. Clinical lung tissue biopsy diagnosis of SCLC
3. Suitable for enough lung tissue biopsy of SCLC
4. Random and double blind
5. Measurable disease
6. Adequate organ functions
7. Adequate performance status
8. Age 24 years old and over
9. Sign an informed consent form
10. Receive blood-drawing

The exclusion criteria:

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
7. Serious Allergy to Drugs
8. Clot or 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

1 site in 1 country.

United States1 site

Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701
Rockville, Maryland, 20853

Other trials in United States

About this study

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

Explore the relationship between drug target CYP4503A4 gene single nucleotide polymorphisms and Etoposide (VP-16) side-effects in patients with small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.

Read the detailed description

The usual approach group, after lung tissue biopsy, 300 double blind random group separated SCLC patients currently used the Chemotherapy on ETOPOSIDE capsule, it will try to look for the relationship between the ETOPOSIDE therapeutic efficacy and the Topoisomerase II SNP Genotyping, and the relationship between the ETOPOSIDE therapeutic safety and the CYP4503A4 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.

The study approach group, after lung tissue biopsy, 300 double blind random group separated SCLC patients currently used the Chemotherapy on China Import Etoposide Capsule, it will try to look for the relationship between the ETOPOSIDE therapeutic efficacy and the Topoisomerase II SNP Genotyping, and the relationship between the ETOPOSIDE therapeutic safety and the CYP4503A4 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.

1) Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double blind SCLC patients.
2) Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind SCLC patients.
3) Calculate drug target gene SNPs in all 600 recruited double blind SCLC patients.
4) Correlate everyone patient drug target gene SNP to everyone patient drug efficacy.
5) Correlate everyone patient drug target gene SNP to everyone patient drug safety.
6) Mutually compare the usual approach group SNPs (300 double blind random group separated SCLC patients) with the study approach group SNPs (300 double blind random group separated SCLC patients).
7) Confirm the relationship between drug target gene SNPs and drug efficacy.
8) Confirm the relationship between drug target gene SNPs and drug safety.

Conditions: Small Cell Lung Cancer
Being tested: ETOPOSIDE - Usual, ETOPOSIDE - Study
Keywords: SCLC, Etoposide, SNP, Topo, CYP, Genotype, Oncology, Genetics, Lung, Cancer
Medical subject headings: Small Cell Lung Carcinoma, Neoplasms

What participants receive

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

ETOPOSIDE - UsualDrug
Also called Usual Etoposide Capsule Chemotherapy
Etoposide Capsule
ETOPOSIDE - StudyDrug
Also called Study Etoposide Capsule Chemotherapy
China Import Etoposide Capsule

Study groups in NCT01064466
Study group	Role	What they receive
ETOPOSIDE - Usual	Experimental	* Etoposide Capsule * Chemotherapy * Etoposide Capsule * Usual Approach Group Receives: Drug: ETOPOSIDE - Usual
ETOPOSIDE - Study	Experimental	* China Import Etoposide Capsule * Chemotherapy * China Import Etoposide Capsule * Study Approach Group Receives: Drug: ETOPOSIDE - Study

What is being measured

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

Find Etoposide Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.
1. Recruit 300 double blind random group separated SCLC patients currently used the Chemotherapy on Etoposide Capsule after lung tissue biopsy, like as the usual approach group.
2. Recruit 300 double blind random group separated SCLC patients currently used the Chemotherapy on China Import Etoposide Capsule after lung tissue biopsy, like as the study approach group.
3. Assay above every SCLC patient-specific Etoposide (VP-16) drug target (Topoisomerase II) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.
4. Assay above every SCLC patient-specific Etoposide (VP-16) drug target (CYP4503A4) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.
Measured: Duration at least 90 days

Timeline

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

16 Jul 202528 Dec 2026

First posted8 Feb 2010 (estimated)
Study start16 Jul 2025
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 Small Cell Lung CancerStudies 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: Randomised
Intervention model: Parallel groups
Model description: * The usual approach group (Oral) * The study approach group (Oral) (China Import)
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 600 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01064466
Sponsor's protocol ID: IND 178172 Commercial
Other IDs: FWA00015357, NPI - 1831468511, NPI - 1023387701, IRB00009424, IORG0007849, IND 178172
Acronym: Drugs-SNPs
Status last verified: Aug 2026
First submitted: 2 Feb 2010
Last updated: 27 Aug 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?

See locations

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All Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Explore the Relationship Between Single Nucleotide Polymorphisms and Etoposide Response and Toxicity in Patients With Small Cell Lung Cancer.
ClinicalTrials.gov ID: NCT01064466
Acronym / sponsor ID: Drugs-SNPs / IND 178172 Commercial
Conditions: Small Cell Lung Cancer
Keywords: SCLC, Etoposide, SNP, Topo, CYP, Genotype, Oncology, Genetics
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 600 participants (estimated)
Lead sponsor: Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB ChairIndustry (pharma, biotech, devices)
Collaborators: UnitedHealthcare
Study start: 16 Jul 2025 (actual)
Primary completion: 18 Nov 2026 (estimated)
Study completion: 28 Dec 2026 (estimated)
First posted: 8 Feb 2010 (estimated)
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.

Detailed description

1) Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double blind SCLC patients.
2) Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind SCLC patients.
3) Calculate drug target gene SNPs in all 600 recruited double blind SCLC patients.
4) Correlate everyone patient drug target gene SNP to everyone patient drug efficacy.
5) Correlate everyone patient drug target gene SNP to everyone patient drug safety.
6) Mutually compare the usual approach group SNPs (300 double blind random group separated SCLC patients) with the study approach group SNPs (300 double blind random group separated SCLC patients).
7) Confirm the relationship between drug target gene SNPs and drug efficacy.
8) Confirm the relationship between drug target gene SNPs and drug safety.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: * The usual approach group (Oral) * The study approach group (Oral) (China Import)

Arm	Type	Receives
ETOPOSIDE - Usual	Experimental	Drug: ETOPOSIDE - Usual* Etoposide Capsule * Chemotherapy * Etoposide Capsule * Usual Approach Group
ETOPOSIDE - Study	Experimental	Drug: ETOPOSIDE - Study* China Import Etoposide Capsule * Chemotherapy * China Import Etoposide Capsule * Study Approach Group

Who may qualify

Ages: 24 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

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
ETOPOSIDE - UsualAlso: Usual Etoposide Capsule ChemotherapyEtoposide Capsule	Drug	ETOPOSIDE - Usual
ETOPOSIDE - StudyAlso: Study Etoposide Capsule ChemotherapyChina Import Etoposide Capsule	Drug	ETOPOSIDE - Study

Primary outcome

Find Etoposide Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.
Time frame: Duration at least 90 days
1. Recruit 300 double blind random group separated SCLC patients currently used the Chemotherapy on Etoposide Capsule after lung tissue biopsy, like as the usual approach group. 2. Recruit 300 double blind random group separated SCLC patients currently used the Chemotherapy on China Import Etoposide Capsule after lung tissue biopsy, like as the study approach group. 3. Assay above every SCLC patient-specific Etoposide (VP-16) drug target (Topoisomerase II) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing. 4. Assay above every SCLC patient-specific Etoposide (VP-16) drug target (CYP4503A4) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.

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 27 Aug 2026.
FWA \< 00015357 \> \< Medicine Invention Design Incorporation (MIDI) \>Link provided by the sponsor.
IRB \< 00009424 \> \< Medicine Invention Design Incorporation (MIDI) \>Link provided by the sponsor.
IORG \< 0007849 \> \< Medicine Invention Design Incorporation (MIDI) \>Link provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Small Cell Lung Cancer

Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 3
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
Non-small Cell Lung Cancer
Recruiting
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RecruitingPhase 2
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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. (MIDI) - IORG0007849 - NPI 1023387701

HAN XU, MD/PhD/FAPCR study director

Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701

HAN XU, MD/PhD/FAPCR study chair

Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701

1 site 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 ETOPOSIDE - Usual and ETOPOSIDE - Study in people with Small Cell Lung Cancer, run by Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair at 1 site 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?

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 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Find Etoposide Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated. (time frame: Duration at least 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01064466.

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 27 Aug 2026.