Clinical trial · Interventional
Study of Anlotinib Hydrochloride Capsule in Subjects With Small Cell Lung Cancer
A Randomized, Double-Blind, Multicenter, Phase Ⅲ Study of Anlotinib Hydrochloride Capsule Combined With Topotecan Versus Placebo Combined With Topotecan in Subjects With Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Anlotinib hydrochloride is a multi-targeted receptor tyrosine kinase inhibitor that targets angiogenesis-related kinases such as VEGFR1/2/3, FGFR1/2/3, and other tumor-associated kinases involved in cell proliferation such as PDGFRα/β, c-Kit, and Ret have significant inhibitory activities.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib | Drug | — | UNRESOLVED |
| Placebos | Drug | — | UNRESOLVED |
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Anlotinib hydrochloride capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and topotecan 1.5mg/m2 IV d1-5.
- interventionNames
- Drug: Anlotinib
- Drug: Topotecan
- type
- PLACEBO_COMPARATOR
- label
- Placebo group
- description
- Anlotinib hydrochloride placebo given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and topotecan 1.5mg/m2 IV d1-5.
- interventionNames
- Drug: Placebos
- Drug: Topotecan
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Small cell lung cancer patients. 2. The clinical stage at baseline is extensive. 3. A measurable lesion. 4. Disease progression. 5. ≥ 18 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months. 6. Adequate laboratory indicators. 7. No pregnant or breastfeeding women, and a negative pregnancy test. 8. Understood and signed an informed consent form. Exclusion Criteria: 1. Has used topotecan and anlotinib hydrochloride capsules. 2. Has used other anti-angiogenic drugs and immunologically targeted drugs. 3. Has other malignant tumors within 5 years. 4. Symptomatic brain metastasis. 5. Has a variety of factors affecting oral medications. 6. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage. 7. Spinal cord compression. 8. Has received radiotherapy, chemotherapy, surgery less than 4 weeks before randomization. 9. Adverse events caused by previous treatment did not recover to grade 1. 10. Has received major surgical treatment within 4 weeks before randomization. 11. Arteriovenous thrombosis occurred within 6 months. 12. Has drug abuse history that unable to abstain from or mental disorders. 13. Has severe or uncontrolled disease. 14. Participated in other clinical trials within 4 weeks. 15. Tumor invades the large blood vessels. 16. Daily hemoptysis ≥2.5 mL within 1 month before the first dose. 17. According to the investigators' judgement.
References
Publications (0)
Data not yet available