NCT07145333Active, not recruitingPhase 2/3
Pharmacogenomics ANDA SNP Clinical Study - Topotecan and Single Nucleotide Polymorphisms
Explore the Relationship Between Single Nucleotide Polymorphisms and Topotecan Response and Toxicity in Patients With Small Cell Lung Cancer.
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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. 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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 14 Aug 2025
- Start date
- 5 Oct 2026
- Primary completion date
- 18 Dec 2026
- Lead sponsor
- Han Xu, M.D., Ph.D., FAPCR, Medical Director, IRB Chair
- Diseases
- Lung cancer
- NCT number
- NCT07145333
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 600
- From 5 Oct 2026 to the primary completion date, 18 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 2\. Treatment with other anti-cancer therapies and cannot be stopped currently
- 9\. Serious Risks or Serious Adverse Events of the drug product
- 10\. The prohibition of drug products
Other illness
- 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
Other
- 1\. Pneumonectomy
- 3\. Pregnancy
- 4\. Breast-feeding
- 8\. Clot or Bleed Tendency
- 11\. Have no therapeutic effects
- 12\. Follow up to the most current label
Who the study is looking for
- 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
Criteria the registry did not label
- 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 Topotecan 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 Topotecan Capsule after lung tissue biopsy, like as the study approach group.
Age in the registry: 24 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medicine Invention Design Incorporation Coordinator of this site? Confirm its status | Rockville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.