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

Sponsor
First People's Hospital of Hangzhou
Study ID
NCT04757779
Phase
PHASE2
Status
Unknown

Conditions

  • Anlotinib
  • Relapsed Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • anlotinib hydrochloride combined with irinotecan or docetaxel — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 30, 2019
Status verified
Feb 2021
Primary completion
Dec 30, 2022
Completion
Dec 30, 2024

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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). 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.

Primary Outcome Measure

objective response rate（ORR） [ Time Frame: 2 years ]

Central Contacts

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