Toripalimab Plus Anlotinib for the Maintenance of Extensive Stage Small Cell

This is a randomized, open, multicenter Phase III clinical study. A total of 136 participants are planned to be enrolled and randomly assigned to either the experimental group (platinum+etoposide → toripalimab plus anlotinib) or the control group (platinum+etoposide+ toripalimab → toripalimab) in a 1:1 ratio. The primary efficacy measures include PFS, while secondary endpoints include OS, DOR, ORR, DCR, progression free survival at 6 and 12 months, overall survival at 12 and 18 months, health-related quality of life (FACT-L), safety, etc. And in the III clinical study, tissue samples were collected before treatment, and tumor tissue and blood samples were taken from some patients after 3 cycles of maintenance treatment and treatment progression for single-cell sequencing and transcriptome sequencing to verify the underlying mechanism research

NCT Number	NCT06441344
Lead Sponsor	Taizhou Hospital
Conditions	SCLC, Maintenance Treatment
Enrollment	136 participants
Start Date	2024-07-01
Primary Completion	2026-05-01 (estimated)
Study Completion	2030-05-01 (estimated)
Updated on ClinicalTrials.gov	2024-06-04