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- Title
A Single-Arm Multi-Center Phase II Clinical Trial of Cadonilimab (anti-PD-1/CTLA-4) in Combination with or without Conventional Second-Line Treatment for Patients with Extensive Stage Small Cell Lung Cancer.
- Authors
Chen, Can; Chen, Minjun; Bai, Yuju; Li, Yajun; Peng, Jie; Yao, Biao; Feng, Jiangping; Zhou, Jian-Guo; Ma, Hu
- 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.
- Subjects
SMALL cell lung cancer; BISPECIFIC antibodies; CLINICAL trials
- Publication
Technology in Cancer Research & Treatment, 2024, p1
- ISSN
1533-0346
- Publication type
Article
- DOI
10.1177/15330338241249690