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.
The subjects voluntarily participated in the study with full informed consent and signed written informed consent form.
Aged ≥18 years on day fo signing the informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy ≥ 3 months
Histologically or cytological confirmed the presence of mixed small cell lung cancer or non-small cell lung cancer components.
Toxicities from previous anti-tumor treatments have not resolved to grade 0 or 1 based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0), or to the levels specified in inclusion/exclusion criteria, except for alopecia.
Symptoms or signs of primary disease deterioration that the investigator judges clinically unacceptable, such as cachexia.
Presence of pleural effusion, pericardial effusion, or ascites, which was clinically symptomatic or requiring frequent drainage.
Parallel
AK112
DrugAK112 20mg/kg, intravenous \[IV\]),Q3W
Placebo
Other interventionPlacebo, intravenous \[IV\]),Q3W
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
Overall Survival (OS)
OS is defined as the time from randomization or first dosing to death due to any cause.
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
Objective Response Rate (ORR) assessed by BICR Per RECIST v1.1
ORR assessed by investigator Per RECIST v1.1
Disease control rate(DCR) assessed by BICR per RECIST v1.1
