NCT04757779

A Single-arm, Phase Ⅱ Clinical Trial of Anlotinib Hydrochloride Combined With Irinotecan or Docetaxel for Second Line Treatment of Nonsensitive Relapsed Small-cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: First People's Hospital of Hangzhou · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Anlotinib hydrochloride is a multi-target antiangiogenic drug. It was recommended by Chinese Society of Clinical Oncology(CSCO) guideline as a third-line treatment for advanced small-cell lung cancer. This study intends to assess the efficacy and safety of anlotinib hydrochloride combined with irinotecan or docetaxel for second line treatment of nonsensitive relapsed small-cell lung cancer.

Conditions

• Relapsed Small Cell Lung Cancer
• Anlotinib

Interventions

Type	Name	Description
DRUG	anlotinib hydrochloride combined with irinotecan or docetaxel	From the start of the study, the subjects are orally administered with anlotinib 12mg on empty stomach.Subjects need to take anlotinib 2 weeks continuously and stop for 1 week(every 3 weeks is a cycle),the dose of anlotinib can be adjusted as 12mg,10mg or 8mg according to adverse effects.On Day1 and Day8, subjects are required to inject irinotecan (65mg/m2)or docetaxel (60mg/m2) of a cycle,until disease progression or intolerable toxicity, for 4 cycles at most.

Timeline

• Start date: 2019-12-30
• Primary completion: 2022-12-30
• Completion: 2024-12-30
• First posted: 2021-02-17
• Last updated: 2021-02-17

Locations

1 site across 1 country: China