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

Phase 3

• Conditions: Small Cell Lung Cancer
• Interventions: Drug: Placebos; Drug: Anlotinib; Drug: Topotecan

• Registration Number: NCT04073550
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-27
• Study First Submitted QC: 2019-08-27
• Last Update Submitted: 2019-08-27
• Study First Posted: 2019-08-29
• Last Update Posted: 2019-08-29
• Study Start: 2019-10-31
• Primary Completion: 2021-07-31
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 184

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Topotecan	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.
Placebo group	Placebos	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.
Experimental group	Anlotinib	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.
Placebo group	Topotecan	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Serious Adverse Event (SAE)	up to 24 months	Safety data
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.
Disease Control Rate (DCR)	up to 24 months	Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
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.
Overall Response Rate (ORR)	up to 24 months	Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR).
Duration of Overall Response (DOR)	up to 24 months	The time when the patient first achieved complete or partial remission to disease progression.
OS rate at month 6	up to 6 months	The percentage of OS at month 6.
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
Abnormal laboratory test index	up to 24 months	Safety data

Trial Locations

Locations (2)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China