This is a randomized, double-blind, multicenter phase III clinical study to evaluate efficacy and safety of anlotinib hydrochloride capsule combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in subjects with advanced non-squamous cell non-small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
369
Anlotinib hydrochloride capsule 12mg 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)
Carboplatin injection AUC 5mg/mL/min, intravenous drip, on Day 1 in 21-day cycle.
Pemetrexed disodium f Injection 500mg / m2, intravenous drip, on Day 1 in 21-day cycle.
Placebo
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGAnhui Chest Hospital
Hefei, Anhui, China
RECRUITINGYijishan Hospital of Wannan Medical College
Wuhu, Anhui, China
RECRUITINGBeijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Progression free survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Time frame: up to 48 weeks
Overall response rate (ORR) assessed by Independent Review Committee (IRC)
Percentage of subjects achieving complete response (CR) and partial response (PR) based on IRC.
Time frame: up to 48 weeks
Overall survival (OS)
OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
Time frame: up to 48 weeks
Disease control rate(DCR)
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time frame: up to 48 weeks
Disease of Response (DOR)
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Time frame: up to 48 weeks
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Peking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe Sixth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGXuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGChinese Academy of Medical Sciences, Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGThe Second Affiliated Hospital of Chinese PLA Army Medical University
Chongqing, Chongqing Municipality, China
RECRUITING...and 49 more locations