This is a randomized, controlled, open-label, multicenter study to evaluate efficacy of AK105 injection combined with Anlotinib Hydrochloride Capsules versus standard second-line chemotherapy. Patients are treated with AK105 injection combined with Anlotinib Hydrochloride Capsules or standard second-line chemotherapy, with 1:1 random ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
528
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).
AK105 200mg intravenously (IV) on Day 1 of each 21-day cycle.
Paclitaxel injection 80mg / m² IV on Days 1, 8 and 15 of each 28-day cycle.
Overall survival (OS)
OS defined as the time from randomization to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Time frame: up to 45 weeks
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 45 weeks
Overall response rate (ORR)
Percentage of subjects achieving complete response (CR) and partial response (PR).
Time frame: up to 45 weeks
Disease control rate (DCR)
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time frame: up to 45 weeks
Duration 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 45 weeks
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Docetaxel injection 75mg / m² IV every 3 weeks of each 21-day cycle.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Shijitan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
The Sixth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, China
Beijing Luhe Hospital Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Quanzhou First Hospital
Quanzhou, Fujian, China
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
...and 35 more locations