Study of Anlotinib Hydrochloride Capsule in Subjects With Small Cell Lung Cancer

• Status: Not yet recruiting
• Trial end date: 2022-07-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Treatments: Topotecan

Criteria

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.