Small Cell Lung Cancer
Conditions
Brief 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.
Interventions
DRUGTopotecan
A topoisomerase I inhibitor.
DRUGAnlotinib
A multi-target receptor tyrosine kinase inhibitor.
DRUGPlacebos
Anlotinib blank analog capsule.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) evaluated by IRC | up to 24 months | PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause; IRC defined as Independent Review Committee. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | up to 24 months | OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. |
| Overall Response Rate (ORR) | up to 24 months | Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR). |
| Disease Control Rate (DCR) | up to 24 months | Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD). |
| Duration of Overall Response (DOR) | up to 24 months | The time when the patient first achieved complete or partial remission to disease progression. |
| PFS rate at month 6 | up to 6 months | The percentage of PFS at month 6. |
| Progression Free Survival (PFS) evaluated by investigator | up to 24 months | PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause. |
| OS rate at month 12 | up to 12 months | The percentage of OS at month 12. |
| The efficacy of intracranial lesions | up to 24 months | To evaluate the efficacy of of intracranial lesions. |
| Adverse Event (AE) | up to 24 months | Safety data |
| Serious Adverse Event (SAE) | up to 24 months | Safety data |
| Abnormal laboratory test index | up to 24 months | Safety data |
| OS rate at month 6 | up to 6 months | The percentage of OS at month 6. |
Countries
China
Contacts
Primary ContactYuanKai Shi, Master
Outcome results
None listed