ABSTRACT
BACKGROUND: Cadonilimab (AK104) is a bispecific IgG-single-chain Fv fragment (ScFv) antibody that binds to PD-1 and CTLA-4. Cadonilimab has shown encouraging anti-tumour activity and a favourable safety profile in several tumour types. In second-line treatment, there is no defined standard of care for patients with extensive-stage small-cell lung cancer (ES-SCLC). Cadonilimab is expected to show substantial clinical efficacy. OBJECTIVE: To assess the antitumor activity and safety of cadonilimab monotherapy or combination with conventional therapy in ES-SCLC patients who failed first-line treatment. METHODS: In this multicenter, open-label, phase II study, ES-SCLC patients who had failed first-line treatment, also aged 18 years to 70 years with histologically or cytologically confirmed ES-SCLC, and an Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0-2 were eligible. Patients will receive cadonilimab 10 mg/kg every three weeks (Q3 W) among 24 months until progressive disease (PD) or adverse events (AE) discovery. The primary endpoint is progression-free survival (PFS). TRIAL REGISTRATION: NCT05901584.
Subject(s)
CTLA-4 Antigen , Lung Neoplasms , Programmed Cell Death 1 Receptor , Small Cell Lung Carcinoma , Humans , Lung Neoplasms/drug therapy , Lung Neoplasms/pathology , Small Cell Lung Carcinoma/drug therapy , Small Cell Lung Carcinoma/pathology , Male , CTLA-4 Antigen/antagonists & inhibitors , Female , Middle Aged , Aged , Programmed Cell Death 1 Receptor/antagonists & inhibitors , Adult , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Neoplasm Staging , Immune Checkpoint Inhibitors/therapeutic use , Treatment Outcome , Young Adult , Antibodies, Monoclonal, Humanized/therapeutic use , Antibodies, Monoclonal, Humanized/administration & dosage , AdolescentABSTRACT
In this study, soil samples around Mawan coal-fired power plant (CFPP) in Shenzhen, a high background radiation area in South China, were analyzed for natural radionuclides. The activity concentration of (226)Ra, (232)Th, and (40)K in soils around Mawan CFPP ranged from approximately 72 to 358 Bq kg(-1) (averaged 204 Bq kg(-1)), 118 to 432 Bq kg(-1) (averaged 265 Bq kg(-1)), and 101 to 2168 Bq kg(-1) (averaged 1269 Bq kg(-1)), respectively, being found to be significantly higher than the world range values. The levels of these radionuclides in soil largely decreased with increasing distance from the CFPP, indicating a technologically enhanced natural radiation near the CFPP. The Raeq values for the soil samples around Mawan CFPP ranged from 346 to 878 Bq kg(-1), most of which exceeded the allowed maximum Raeq value of 370 Bq kg(-1). The operating of CFPP has increased the total radioactive dose received for the nearby population.
