Abstract 723TiP
Background
Immunochemotherapy has become the standard first-line treatment for patients with ES-SCLC. However, treatment options after progression on immunotherapy remain a clinical challenge. The currently recommended second-line chemotherapy brings limited survival benefits for immunotherapy-treated population. This study aims to investigate the efficacy and safety of Lipo-IRI alone or in combination with famitinib (a structural analog of sunitinib) or platinum in patients with ES-SCLC after failure of first-line immunotherapy.
Trial design
This is a multicenter, randomized, open-label, multicohort phase II trial conducted in China. Patients will be eligible if they are aged 18-75 years, have histologically or cytologically confirmed ES-SCLC, have an Eastern Cooperative Oncology Group performance status of 0-1, have progression after first-line immunotherapy, have at least one measurable lesion according to the Response Evaluation Criteria In Solid Tumors (version 1.1), have expected survival of at least 12 weeks, and have adequate organ function. Patients with asymptomatic or stable brain metastases can be enrolled. Prior exposure to anti-angiogenic drugs or topoisomerase I inhibitors is not allowed. A total of 102 patients will be randomly (1:1:1; stratification factor: platinum-sensitive or platinum-resistant disease) assigned to receive Lipo-IRI (100 mg/m2 once every 3 weeks) plus famitinib (20 mg once daily), Lipo-IRI plus investigator-selected platinum, or Lipo-IRI alone until disease progression or intolerable toxicity. The primary endpoint is progression-free survival (PFS). Secondary endpoints include objective response rate, 6-month PFS rate, overall survival, duration of response, disease control rate, and safety. The study is registered with ChiCTR.org.cn, ChiCTR2400083693.
Clinical trial identification
ChiCTR2400083693.
Legal entity responsible for the study
The authors.
Funding
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.