An Umbrella Study of Recurrent, Extensive Stage Small Cell Lung Cancer Based on Molecular Typing
Summary
Small-cell lung cancer (SCLC) has a high degree of malignancy and extremely poor prognosis, slow progress in the treatment of ES-SCLC, and a more ideal posterior therapy needs to be explored. This is an I / II, phase umbrella study to explore afterline treatment options following progression of frontline platinum-containing therapy for small cell lung cancer. This study includes 2 parts: Part 1 will enroll patients with end of first-line platinum-containing therapy and progression interval of less than 180 days or more of second-line therapy (no first-line relapse time required). Part 2 will enroll patients with end of first-line platinum-containing therapy greater than 180 days. Based on the optimal selection of patients with recurrent broad-stage small cell lung cancer with different molecular and clinical characteristics, we further explored different treatment modes suitable for different populations through umbrella cohort studies.
Timeline
- Start
- 2025-12-31
- Primary completion
- 2030-06-30
- Completion
- 2030-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluzoparib | Small molecule | 100 mg | Oral |
| Subject | Lurbinectedin | Other / unclassified | 2.6 mg/m2 | Intravenous |
| Subject | Lurbinectedin | Other / unclassified | 3.2 mg/m2 | Intravenous |
| Subject | Serplulimab | Monoclonal antibody | 4.5 mg/kg | Intravenous |
| Subject | Temozolomide | Small molecule | 150 mg/m2 | Oral |
| Background | Carboplatin | Small molecule | 5 unknown | — |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Background | Etoposide | Small molecule | 100 mg/m2 | — |
| Background | Irinotecan | Small molecule | — | — |
| Background | Paclitaxel | Small molecule | — | — |
| Background | Topotecan | Small molecule | — | — |