SCLCPhase 2/3Drug-SNPNCT07145333

Pharmacogenomics ANDA SNP Clinical Study - Topotecan and Single Nucleotide Polymorphisms

A Phase 2/3 study testing Topotecan - usual and Topotecan - study in people with SCLC, 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 I gene single nucleotide polymorphisms and Topotecan 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: SCLC
What is being tested?: Topotecan - usual and Topotecan - 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: 5 Oct 2026to 28 Jun 2027
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. 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

Show all 10Show fewer

7. Adequate performance status
8. Age 24 years old and over
9. Sign an informed consent form
10. 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. 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 Incorporation
Rockville, Maryland, 20853

Other trials in United States

About this study

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

Explore the relationship between drug target CYP4503A4 gene single nucleotide polymorphisms and Topotecan 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 Topotecan capsule, it will try to look for the relationship between the Topotecan therapeutic efficacy and the Topoisomerase I SNP Genotyping, and the relationship between the Topotecan 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 Topotecan Capsule, it will try to look for the relationship between the Topotecan therapeutic efficacy and the Topoisomerase I SNP Genotyping, and the relationship between the Topotecan 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 double blind SCLC patients.
Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind SCLC patients.
Calculate drug target gene SNPs in all 600 recruited double blind SCLC 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 double blind random group separated SCLC patients) with the study approach group SNPs (300 double blind random group separated SCLC patients).
Confirm the relationship between drug target gene SNPs and drug efficacy.
Confirm the relationship between drug target gene SNPs and drug safety.

Conditions: SCLC
Being tested: Topotecan - usual, Topotecan - study
Keywords: SNP, Topotecan, TOPO, CYP, Genotype

What participants receive

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

Topotecan - usualDrug
Also called Usual Topotecan Capsule Chemotherapy
Topotecan Capsule
Topotecan - studyDrug
Also called Study Topotecan Capsule Chemotherapy
China Import Topotecan Capsule

Study groups in NCT07145333
Study group	Role	What they receive
Topotecan - usual	Experimental	* Topotecan Capsule * Chemotherapy * Topotecan Capsule * Usual Approach Group Receives: Drug: Topotecan - usual
Topotecan - study	Experimental	* China Import Topotecan Capsule * Chemotherapy * China Import Topotecan Capsule * Study Approach Group Receives: Drug: Topotecan - study

What is being measured

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

Find Topotecan 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 Topotecan 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 Topotecan Capsule after lung tissue biopsy, like as the study approach group.
3. Assay above every SCLC patient-specific Topotecan drug target (Topoisomerase I) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.
4. Assay above every SCLC patient-specific Topotecan drug target (CYP4503A4) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.
Measured: Duration up to 14 weeks

Timeline

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

5 Oct 202628 Jun 2027

First posted28 Aug 2025
Study start5 Oct 2026
Primary completion18 Dec 2026 (estimated)
Study completion28 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SCLCStudies 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: NCT07145333
Sponsor's protocol ID: IND 178174 Commercial
Other IDs: FWA00015357, NPI-1831468511, NPI-1023387701, IRB00009424, IORG0007849, IND178174
Acronym: Drug-SNP
Status last verified: Oct 2026
First submitted: 14 Aug 2025
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?

See locations

RecruitingObservational study
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A Study to Test How Well Different Doses of Obrixtamig (BI 764532) in Combination With Ezabenlimab Are Tolerated by People With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3
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Active, not recruitingPhase 1
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All SCLC trials

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 Topotecan Response and Toxicity in Patients With Small Cell Lung Cancer.
ClinicalTrials.gov ID: NCT07145333
Acronym / sponsor ID: Drug-SNP / IND 178174 Commercial
Conditions: SCLC
Keywords: SNP, Topotecan, TOPO, CYP, Genotype
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: 5 Oct 2026 (actual)
Primary completion: 18 Dec 2026 (estimated)
Study completion: 28 Jun 2027 (estimated)
First posted: 28 Aug 2025 (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.

Detailed description

Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double blind SCLC patients.
Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind SCLC patients.
Calculate drug target gene SNPs in all 600 recruited double blind SCLC 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 double blind random group separated SCLC patients) with the study approach group SNPs (300 double blind random group separated SCLC 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: 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
Topotecan - usual	Experimental	Drug: Topotecan - usual* Topotecan Capsule * Chemotherapy * Topotecan Capsule * Usual Approach Group
Topotecan - study	Experimental	Drug: Topotecan - study* China Import Topotecan Capsule * Chemotherapy * China Import Topotecan Capsule * Study Approach Group

Who may qualify

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

Key inclusion criteria (10 listed)

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

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
Topotecan - usualAlso: Usual Topotecan Capsule ChemotherapyTopotecan Capsule	Drug	Topotecan - usual
Topotecan - studyAlso: Study Topotecan Capsule ChemotherapyChina Import Topotecan Capsule	Drug	Topotecan - study

Primary outcome

Find Topotecan Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.
Time frame: Duration up to 14 weeks
1. Recruit 300 double blind random group separated SCLC patients currently used the Chemotherapy on Topotecan 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 Topotecan Capsule after lung tissue biopsy, like as the study approach group. 3. Assay above every SCLC patient-specific Topotecan drug target (Topoisomerase I) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing. 4. Assay above every SCLC patient-specific Topotecan 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 8 Oct 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 SCLC

RecruitingObservational study
Exploration of Whole-Brain Radiotherapy Combined With PD-1 Inhibitors on Brain Injury
Small Cell Lung Cancer ( SCLC ), Brain Injury
RecruitingPhase 2
A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC)
Small Cell Lung Cancer ( SCLC )
RecruitingPhase 3
DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemoimmunotherapy
Small Cell Lung Cancer (SCLC), Extensive-stage Small Cell Lung Cancer (ES-SCLC)
Active, not recruitingPhase 1
A Study to Test How Well Different Doses of Obrixtamig (BI 764532) in Combination With Ezabenlimab Are Tolerated by People With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3
Small Cell Lung Carcinoma (SCLC), Neuroendocrine Neoplasms
Active, not recruitingPhase 1
DAREONᵀᴹ-8: A Study to Test How Well Different Doses of BI 764532 in Addition to Standard of Care Are Tolerated by People With Advanced Small Cell Lung Cancer
Small Cell Lung Carcinoma (SCLC)

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 study chair

Medicine Invention Design, Inc. - IRB00009424 - IORG0007849

HAN XU, MD/PhD/FAPCR study director

Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701

HAN ID XU, MD/PhD/FAPCR principal investigator

Medicine Invention Design, Inc. - 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 Topotecan - usual and Topotecan - study in people with SCLC, 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?

The sponsor lists 10 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 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 Topotecan Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated. (time frame: Duration up to 14 weeks). 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 NCT07145333.

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.