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.