This is a randomized, double-blind, phase III clinical study to compare the efficacy and safety of AK112 to placebo as consolidation treatment for patients with limited stage small cell lung cancer who have not progressed following concurrent chemoradiation therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
560
Progression-Free Survival(PFS) assessed by Blinded independent center review(BIRC)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST v1.1
Time frame: Approximately 6 years
Overall Survival (OS)
OS is defined as the time from randomization or first dosing to death due to any cause.
Time frame: Approximately 6 years
PFS assessed by investigator per RECIST v1.1
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST v1.1
Time frame: Approximately 6 years
Objective Response Rate (ORR) assessed by BICR Per RECIST v1.1
Time frame: Approximately 6 years
ORR assessed by investigator Per RECIST v1.1
Time frame: Approximately 6 years
Disease control rate(DCR) assessed by BICR per RECIST v1.1
Time frame: Approximately 6 years
DCR assessed by investigator per RECIST v1.1
Time frame: Approximately 6 years
Duration of Response (DOR) assessed by BICR per RECIST v1.1
Time frame: Approximately 6 years
DOR assessed by investigator per RECIST v1.1
Time frame: Approximately 6 years
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe First Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Chest Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGCancer Hospital, Chinese Academy of Medical Sciences
Beijin, Beijin, China
RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGFujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGPLA No. 900 Hospital of the Joint Support Force
Fuzhou, Fujian, China
RECRUITINGLongyan First Hospital
Longyan, Fujian, China
RECRUITINGZhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, China
RECRUITING...and 43 more locations
Number of participants with adverse event (AE)
The number of participants experiencing an AE and the severity of AEs will be assessed. AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.
Time frame: Approximately 6 years