Anlotinib has been approved as a third-line treatment for advanced non-small-cell lung cancer. A phase II clinical studies of small cell lung cancer (ALTER-1210) also showed that, compared with placebo, Anlotinib could improve the patients survival and had less toxic side effects after 2-3 line therapy. The purpose of this multicenter, randomized, prospective study is to investigate the efficacy and safety of Anlotinib as the maintenance therapy for Extensive-stage small cell lung cancer after combined with etoposide and cisplatin chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
116
etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1 and Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle, repeated every 21 days
etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, repeated every 21 days
Progression-free survival
The first day of treatment to the date that disease progression is reported
Time frame: From randomization,each 42 days up to PD or death(up to 24 months
Overall survival
The first day of treatment to death or last survival confirm date
Time frame: From randomization until death (up to 5 years)
Objective Response Rate
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Treatment-related adverse events
Treatment-related adverse events are assessed by common terminology criteria for adverse events(CTCAE) V4.0.
Time frame: the first date of treatment to 30 days after the last dose of study drug,assessed up to 24 months
Performance Status
Performance Status of patients will be assessed by Zubrod-Eastern cooperative oncology group(ECOG)-world health organization(WHO).
Time frame: the first date of treatment to 30 days after the last dose of study drug, assessed up to 24 months
Disease Control Rate
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
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