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

C

CTTQ

Status and phase

Unknown
Phase 3

Conditions

Small Cell Lung Cancer

Treatments

Drug: Placebos
Drug: Anlotinib
Drug: Topotecan

Study type

Interventional

Funder types

Industry

Identifiers

NCT04073550
ALTN-12-III-01

Details and patient eligibility

About

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.

Enrollment

184 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

184 participants in 2 patient groups, including a placebo group

Experimental group
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.
Treatment:
Drug: Anlotinib
Drug: Topotecan
Placebo group
Placebo Comparator 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.
Treatment:
Drug: Placebos
Drug: Topotecan

Trial contacts and locations

2

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Central trial contact

YuanKai Shi, Master

Data sourced from clinicaltrials.gov

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